LMI May 2016

V I S I T

W O R L D ’ S C L I N I C A L L A B O R AT O R Y N E W S L E A D E R ISSN 1068-1760

Vol. 33 No. 3 • 5/ 2016

DAILY CLINICAL LAB NEWS

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Novel Immunoassay To Diagnose Dengue

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ntil now, it has been difficult to diagnose whether someone is suffering from dengue fever or whether they have contracted another flavivirus, such as yellow fever, West Nile virus, or Tick-borne encephalitis virus (TBEV).

Although there are already tests on the market, but none of them can

n a new approach using quantitative targeted proteomics, researchers have for the first time developed a way to use mass-spectrometry to measure hundreds of organ proteins in a single blood sample. The resulting protein patterns can help determine sepsis severity, which organs have been damaged, and may

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lead to faster diagnostics.

“We use the blood as a mirror reflecting what happens in the body,” said Johan Malmström biomedical scientist at Lund University (Lund, Sweden; www.lunduniversity.lu.se), whose brothers, medical intern Erik Malmström (Lund U.) and bioinformatician Lars Malmström University Cont’d on page 9

Image: Courtesy of EUROIMMUN

First Antibody Diagnostics Introduced for Zika Virus A

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urine diagnostic test has been created for prostate cancer that could mean that invasive diagnostic procedures that men currently undergo eventually become a thing of the past.

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Blood Test Detects Genes for All Known Inherited Heart Conditions

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rapid, simple blood test has been developed that can accurately detect all known genes associated with inherited heart conditions which are characterized by marked genetic and allelic heterogeneity and require extensive sequencing for genetic characterization.

Inherited heart conditions are

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new discovery about genetics underlying ischemic stroke may enable doctors to identify patients in greatest danger of having a second stroke using a commonly performed blood test and genetic profiling.

Researchers have now linked high levels of C-Reactive Protein (CRP) with increased risk for recurrent ischemic stroke. CRP, detectable in blood, is produced in the liver in response to inflammation, and is already

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Urine Diagnostic Test for Urological Malignancies

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fast, inexpensive and highly accurate test to screen newborns for cystic fibrosis has been developed.

The new method detects virtually all mutations in the cystic fibrosis gene, preventing missed diagnoses that delay babies’ ability to begin receiving essential treatment.

Cystic fibrosis (CF), which causes mucus to build up in the lungs, pancreas and other organs, is the most common fatal genetic disease in the

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Simple Blood Test Could Predict Risk of 2nd Stroke

Image: Indirect immunofluorescence (IIF) assay of cells infected with Zika virus

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new panel of two serological assays for Zika virus (ZIKV) infection fill the need for the rapid diagnosis and screening of wide populations. The tests enable sensitive and specific detection of antibodies (IgM, IgG) against the virus in blood of infected patients.

See article on page 4

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Advanced Test for Cystic Fibrosis

Protein Patterning: New Tool for Diagnosing Sepsis

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caused by gene mutations that have been passed down from relatives. If a mother possesses one of these faulty genes, there is a 50% chance that they will pass the mutation on to their child. These heart conditions include aortic valve disease, structural heart disease, long and short QT syndrome, Cont’d on page 8

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First Antibody Tests Available for Zika Virus new panel of two serological assays for Zika virus (ZIKV) infection fill the need for the rapid diagnosis and screening of wide populations.

The tests enable sensitive and specific detection of antibodies (IgM, IgG) against the virus in blood of infected patients. The test package, developed by Euroimmun AG (Luebeck, Germany; www.euroimmun.com), contains ELISA and indirect immunofluorescence (IIF) diagnostic tests and will shortly be used in studies at Fiocruz (Fundacao Oswaldo Cruz), an institute linked to the Brazilian health ministry.

“We have reacted immediately to the acute demand and developed ELISA and IIF tests which we have evaluated in cooperation with the Bernhard-Nocht Institute in Hamburg. The tests are suitable for the fast screening of large sample numbers and therefore enable monitoring of the virus spread,” said Katja Steinhagen, head of ELISA Infectious Serology, Euroimmun.

Serological tests are an important diagnostic supplement to direct detection, which is only effective during the viremic phase. Serological analyses are, moreover, crucial for epidemiological studies and monitoring. The Euroimmun test can detect both acute infections (in most cases from day-5 after onset of symptoms) and past infections. Test systems for direct detection of the virus (e.g., PCR) are useful only up to 5 days after onset of symptoms – after this, the virus itself is no longer detectable.

Zika fever is difficult to distinguish clinically from dengue fever and chikungunya fever, which manifest with similar symptoms and are endemic in much the same geographic regions. Thus, laboratory tests are crucial for effective differential diagnostics.

“Our ELISAs are based on very specific, recombinant antigens which are produced in our own research laboratories. Positive results are a clear indicator of a Zika virus infection” said Katja Steinhagen, “And our special immunofluorescence mosaics help laboratory physicians to investigate patient samples for other viral fever diseases in parallel. This is important for differential diagnosis, since in Latin America there are also dengue and chikungunya viruses, which cause similar symptoms and are transmitted by the same species of mosquitoes as the Zika virus. We hope our test systems can help to clarify as soon as possible whether there is a link between the cases of microcephaly and Zika infections.”

Euroimmun’s Anti-Zika Virus ELISA (IgM or IgG) tests provide automated detection using microplates coated with recombinant non-structural protein (NS1) from ZIKV. This highly specific antigen reduces cross-reactivity with other flaviviruses.

Euroimmun’s Anti-Zika Virus IIFT (IgM or IgG) utilizes ZIKV-infected cells as the antigenic substrate. Positive and negative results are easily evaluated by microscopy. With the “Arboviral Fever Mosaic 2, the ZIKV substrate is incubated in parallel with substrates for Chikungunya virus and Dengue virus serotypes 1 to 4.

This BIOCHIP combination enables secure interpretation of test results and differential diagnostic delimitation of ZIKV, Dengue virus, and Chikungunya virus infections.

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Researchers: Spread of Zika Outbreak Likely to Cross the Ocean In a new review, infectious disease experts provide recommendations and information about current risks posed by the Zika virus, and predict that the outbreak will shortly spread from the Americas into Africa and

Southern Europe.

Experts at the European Society of Clinical Microbiology & Infectious Diseases (ESCMID; Basel Switzerland; www.escmid.org) and its study group on Travelers & Migrants (ESGITM) are conducting research to gather more solid data to better assess risks associated with infection. They point to the need to find evidence on how the Zika virus affects the body, why it is spreading rapidly in the Americas, how else it can be transmitted apart from mosquito bites, and whether it is linked with congenital defects in babies and nervous system diseases.

The researchers discussed the threat posed, particularly to residents of Brazil and attendees of the upcoming 2016 Rio Olympics. They are also preparing for a possible outbreak in Europe and a return of the virus to the African continent where it was first isolated – Zika Forest, Uganda, 1947.

An international team led by Prof. Eskild Petersen from Aarhus University (Denmark) and Prof. Alimuddin Zumla, University College London (UK), published the review that concludes: “Molecular analyses of the virus are most urgently needed to understand whether a change in the virus can explain the rapid spread and the association with microcephaly in babies exposed to the virus during pregnancy.” Research is underway into treatments, vaccines, and better diagnostics, which will improve surveillance and assessment of risks.

“The emergence of Zika virus soon after the Ebola outbreak is yet another reminder for the urgent need for a coordinated global effort to have sufficiently resourced rapid-response groups for proactive surveillance and conduct of priority-research in emergency situations,” said Prof. Petersen.

Prof. Hakan Leblebicioglu, ESGITM chairperson, added: “Emerging and re-emerging infections usually arise from resource-limited countries and since the infrastructure for diagnostics is not well-established, the timely diagnosis and control of outbreaks are usually late. For this reason, an international collaboration for capacity-building of the laboratories and technologytransfer is essential.”

ESGITM board member Dr. Nick Beeching, from Liverpool School of Tropical Medicine, notes that Aedes mosquitoes are widespread and already responsible for epidemics due to dengue and chikungunya viruses. It is not known whether other types of mosquito more common in Europe can act as vectors for Zika virus and research on this is urgently needed.

Only 1 in 5 people infected with the virus show any symptoms, so that many people will be unaware that they have been infected. There is infection risk for travel to affected countries, unprotected sexual contact with someone who has recently returned from an affected area, and from transfusion of blood donated by those recently infected.

One of the main questions to be answered is why the virus was able to spread so rapidly now and why such huge outbreaks did not occur before. Also, until the Zika virus RNA sequence is analyzed (months) we will not know if it is a mutation or other factors that play a role in the apparent increased occurrence of microcephaly and Guillain-Barré syndrome in affected regions.

The paper was published February 4, 2016, in the International Journal of Infectious Diseases.

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Simple Blood Test Could Predict Risk of 2nd Stroke cont’d from cover

commonly tested for to measure patient risk of developing coronary artery disease. The new study suggests it could also be used for ischemic stroke patients. “The biggest risk of death for someone who has already had a stroke is to have another one,” said Stephen Williams, PhD, researcher at University of Virginia School of Medicine, UVA Health System (Charlottesville, VA, USA; www.uvahealth.com), “So it’s really important to be able to try and target those individuals who are at the highest risk.”

Ischemic strokes result from blockages preventing blood flow to the brain; they are responsible for approximately 85% of all stroke cases. (Hemorrhagic strokes result when blood vessels burst and bleed into the brain.). To better understand ischemic stroke, Dr. Williams and colleagues set out to determine

how genes affect the levels in blood of biomarkers such as CRP. Not only did they find that elevated CRP levels suggest increased recurrent stroke risk, they identified gene variations that drive those risks.

Dr. Williams envisions that doctors might focus on CRP levels and a patient’s genetic makeup to determine a patient’s overall risk of recurrent stroke.

But even CRP levels alone could be a valuable tool in assessing risk after the initial stroke. “Getting a CRP measure on someone is really simple. It’s just a blood draw. You don’t have to take something like a biopsy, which patients might have an aversion to,” he said, “It’s not very expensive, and it’s part of routine workups that could be done for patients.

However, combined with genetic information, we may have even more power to identify those at greatest risk.”

The study, by Williams SR et al, was published January 26, 2016, in the journal Neurology, on behalf of METASTROKE, the Genomics and Randomized Trials Network Collaborative Research Group.

Image: Red blood cells. A new study suggests that genetic profiling and/or the commonly used C-Reactive Protein (CRP) blood test could help identify ischemic stroke patients who are at high risk of having a second stroke (Photo courtesy of University of Virginia Health System).

Fast and Accurate Cystic Fibrosis Test for Newborns cont’d from cover

USA, affecting 30,000 people. To develop the disease, a child must inherit two mutated copies of the CF gene, one from each parent. Newborns in every state of the USA have been screened for CF since 2010, but the current tests have limitations.

Scientists at the Stanford University Medical Center (CA, USA; www.med.stanford.edu) and their colleagues have developed a highly sensitive, specific, rapid and cost-effective assay for comprehensive cystic fibrosis transmembrane conductance regulator gene (CFTR) analysis from dried blood spots, the common newborn screening specimen.

The unique design of CFseq, as the assay is called, integrates optimized dried blood spot sample processing, a novel multiplex amplification method from as little as one nanogram of genomic DNA, and multiplex next-generation sequencing of 96 samples in a single run to detect all relevant CFTR mutation types.

Sequence data analysis utilizes publicly available software supplemented by an expert-curated compendium of more than 2000 CFTR variants. Validation studies across 190 dried blood spots demonstrated 100% sensitivity and a positive predictive value of 100% for single-nucleotide variants and insertions and deletions and complete concordance across the polymorphic poly-TG and consecutive poly-T tracts. Additionally, they accurately detected both a known exon 2,3 deletion and a previously undetected exon 22,23 deletion. CFseq is thus able to replace all existing CFTR molecular assays with a single robust, definitive assay at significant cost and timesavings and could be adapted to high-throughput screening of other inherited conditions.

Curt Scharfe, MD, PhD, a professor and senior author of the study, said, “The assays in use are time-consuming and don’t test the entire cystic fibrosis gene. They don’t tell the whole story. Ultimately, we would like to develop a broader assay to include the most common and most troublesome newborn conditions, and be able to do the screening much faster, more comprehensively and much more cheaply.” The study was published on January 28, 2016, in the Journal of Molecular Diagnostics.

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Novel Immunoassay to Diagnose Dengue cont’d from cover

tell the difference between these individual flaviviruses and if a definitive diagnosis is required, a sample of the patient’s blood has to be sent to a high-security laboratory for analysis.

Scientists at the Fraunhofer Institute for Cell Therapy and Immunology (Leipzig, Germany; www.izi. fraunhofer.de) have developed a definitive antibody test for Dengue virus. Conventional antibody tests are performed by the health professional who draws the patient’s blood. If infected with the Dengue virus, the blood will contain specific antibodies produced by the body to attack the intruder. The laboratory staffer then

applies the blood to a test platform with dengue antigens that systematically bind with these antibodies. If, after a set reaction time, antibodies are found on the platform, the physician will assume that the patient has been infected with the Dengue virus.

The catch is that, although the antigens bind with the antibodies according to the lock and key principle, they almost always do so at the same site as all other flaviviruses. This means that, even when the test is positive, no one can say for sure that it is actually a case of dengue.

The scientists hope that their test will hit the market around one year from now. In a further step, they are

working on ways to differentiate between the four strains of the dengue pathogen. This could be an important breakthrough: Anyone who has survived a dengue-related illness has then acquired immunity against that specific pathogen, but when it comes to the other three strains, that person is at even greater risk. This is because the antibodies they produced to combat the first bout of dengue fever actually help the new virus to spread and make it much harder for that person to recover.

Dr. Sebastian Ulbert, Head of the Working Group on Vaccine Technologies, said, “We’ve succeeded in developing the first ever antibody test for dengue infections that is capable of distinguishing between dengue and other flaviviruses. Since our test is also based on detecting antibodies, it’s just as cheap and easy to run as its conventional counterparts. Our test system has the potential to differenti-

ate between the four viral strains.”

The new method can easily be integrated into existing test setups and at no extra cost to manufacturers.

Image: Researchers have developed a novel test to detect dengue fever (Photo courtesy of Photo Fraunhofer IZI).

Blood Test Detects All Known Inherited Heart Conditions Genes cont’d from cover

Noonan syndrome, familial atrial fibrillation and most cardiomyopathies.

Scientists at the Imperial College London (UK; www.imperial.ac.uk) working with their colleagues analyzed the blood samples of 348 participants from the National HeartCenter (Singapore; www.nhcs.com. sg). Genomic DNA was extracted from blood using Prepito DNA Blood 600 kit (Perkin Elmer, Waltham, MA, USA; www.perkinelmer.com) for targeted sequencing; EZ1 DSP DNA blood 48 kit (Qiagen, Venlo, Netherlands; www.qiagen.com) for whole exome sequencing, (WES) or the Qiagen QIAsymphony DNA kit for whole genome sequencing (WGS).

Quality and quantity of extracted DNA were assessed by an ultravioletvisible spectrophotometer. For targeted sequencing pooled libraries were prepared using the inherited cardiac conditions (ICC) panel and were sequenced on the MiSeq (108 samples) or NextSeq 500 (144samples) benchtop sequencers (Illumina; San Diego, CA, USA; www.illumina.com) using paired-end, 150 bp reads. Pathogenic or likely pathogenic variants of 26 samples were identified using the ICC panel in a study cohort of 35 samples was subjected to Sanger sequencing.

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identify 174 genes known to increase the risk of 17 inherited heart conditions. The team found that the test was able to quickly identify all gene mutations in the blood samples that were associated with the 17 inherited heart conditions with up to 100% accuracy. The assay has better performance, shorter turnaround times, lesser informatics requirements and lower sequencing costs as compared to the WES, deep WES, and WGS. The assay is called the TruSight Cardio Sequencing Kit. James S. Ware, MD, PhD, a cardiologist and coauthor of the study said, “Without a genetic test, we often have to keep the whole family under regular surveillance for many years, because some of these conditions may not develop until later in life. This is hugely costly for both the families and the health system. By contrast, when a genetic test reveals the precise genetic abnormality causing the condition in one member of the family, it becomes simple to test other family members. Those who do not carry the faulty gene copy can be reassured and spared countless hospital visits. This new comprehensive test is increasing the number of families who benefit from genetic testing.” The study was published on February 17, 2016, in the Journal of Cardiovascular Translational Research.

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Protein Patterning: New Tool for Studying Sepsis cont’d from cover

of Zurich (Zurich, Switzerland; www.uzh.ch/en.html) are fellow researchers on the study. The team has succeeded to map the majority of all detected proteins from vital organs (e.g., heart, lung, liver, spleen, blood vessels) and have listed which proteins were specific to each organ. “If you see in a blood sample that the amount of proteins from a specific organ significantly increases, it indicates damage to this organ. The method provides an understanding of the molecular events that take place during the course of a disease, and the possibility, using the same analysis, to study how different organs are affected”, explained Dr. E. Malmström.

Sepsis is a very complicated and precarious condition in which the immune system starts to react erroneously in different ways to the bacterial infection. It is often difficult to diagnose because symptoms (including high breathing rate, fever, rapid pulse, pain, confusion) occur in milder conditions as well. Disease progression can be very fast and become fatal within a few hours. Therefore, there is a great need for faster diagnosis and better understanding of the course of the disease.

Another researcher, Dr. Adam Linder (Lund U.), has begun to develop a diagnostic method based on HBP, a protein emitted from white blood cells and reflects the risk of hypotension. The Malmström group’s study of hundreds of different proteins could eventually be used to select other important proteins that can serve as biomarkers for different aspects of sepsis.

The new method is already an important research tool: “There is so much we don’t know about sepsis. Why do not all patients react the same way – why do some organs suffer the most damage in some patients and not in others? Do different bacteria cause the disease to progress? Can you divide patients into different subgroups, or bacteria, or does each new combination of patients and bacteria lead to a specific form of sepsis?” asked Dr. E. Malmström. The researchers have conducted their studies on animals and are now moving on to human tissue.

Through a collaboration with surgeons at Skane University Hospital they have obtained samples of healthy tissue. Protein patterns of these samples can then be compared with the corresponding organ tissues in sepsis patients.

“Protein mapping like this has never been done before. The method can also be applied to other diseases for studying how pathological changes in various organs are reflected in a blood sample,” said Dr. Johan Malmström.

The study, by Malmström E, Kilsgard O, Hauri S, Smeds E, Herwald H, Malmström L, & Malmström J, was published January 6, 2016, in the journal Nature Communications.

Image: A red blood cell. Researchers have found that through studying protein patterns in blood samples they can more easily determine how severe a sepsis condition really is (Photo courtesy of Lund University).

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Study Shows Importance of mTORC1 and p21 Signaling in Head and Neck Carcinomas team of Spanish cancer researchers has found that over-activation of the mTORC1/ 4E-BP1/p21 molecular pathway is a frequent and clinically relevant alteration in head and neck squamous cell carcinomas (HNSCC).

Investigators at Centro Nacional de Investigaciones Oncologicas (Madrid, Spain; www.cnio.es) and the Central University Hospital of Asturias (Spain; www.hca.es) analyzed more than 270 biopsies of patients with head and neck cancers and found that about half of them showed high levels of p21 protein as well as mTOR activation.

The p21 (cyclin-dependent kinase inhibitor 1) protein is a potent cyclin-dependent kinase inhibitor, which binds to and inhibits the activity of cyclin-CDK2, -CDK1, and -CDK4/6 complexes, and thus functions as a regulator of cell cycle progression at G1 and S phase. In addition to growth arrest, p21 can mediate cellular senescence. The expression of the CDKN1A gene, which encodes p21, is tightly controlled by the tumor suppressor protein p53, through which this protein mediates the p53-dependent cell cycle G1 phase arrest in response to a variety of stress stimuli.

Mammalian target of rapamycin (mTOR) is a master regulator of protein synthesis that under ordinary conditions induces cells to grow and divide. However, in cancer cells the mTOR pathway does not func-

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tion correctly and signals tumor cells to grow, divide, undergo metastasis, and invade new, healthy tissues.

Functionally, mTOR is the catalytic subunit of two structurally distinct complexes: mTORC1 and mTORC2. Both complexes localize to different subcellular compartments, thus affecting their activation and function. MTORC1 is composed of the proteins mTOR, regulatory-associated protein of mTOR (Raptor), mammalian lethal with SEC13 protein 8 (MLST8), and the non-core components PRAS40 and DEPTOR. This complex functions as a nutrient/energy/redox sensor and controls protein synthesis. The activity of mTORC1 is stimulated by insulin, growth factors, serum, phosphatidic acid, amino acids (particularly leucine), and oxidative stress.

In the current study, the investigators described a new mechanism of regulation of p21 by the mTORC1/4E-BP1 pathway. The 4E-BP1 gene encodes eukaryotic translation initiation factor 4Ebinding protein 1, which is a member of a family of translation repressor proteins. The protein directly interacts with eukaryotic translation initiation factor 4E (eIF4E), which is a limiting component of the multi-subunit complex that recruits 40S ribosomal subunits to the 5’ end of mRNAs. Interaction of this protein with eIF4E inhibits complex assembly and represses translation. This protein is phosphorylated in response to various signals including UV ir-

radiation and insulin signaling, resulting in its dissociation from eIF4E and activation of cap-dependent mRNA translation.

The current study showed that non-phosphorylated 4E-BP1 interacted with p21 and induced its degradation. Accordingly, hyper-activation of mTORC1 resulted in phosphorylation of 4E-BP1 and stabilization of p21. In HNSCC, p21 levels strongly correlated with mTORC1 activity but not with p53 status. Clinical data indicated that HNSCC patients with p21 and phospho-S6-double-positive tumors presented a better disease-specific survival.

The study was published in the February 2, 2016, online edition of the journal Nature Communications.

Image: A section of a head and neck cancer biopsy was stained for p21 (brown) and for S6 phosphorylation (red). S6 phosphorylation depends directly on mTOR and, therefore, its detection is an indication of mTOR activity (Photo courtesy of Centro Nacional de Investigaciones Oncologicas).

Urine Diagnostic Test Created for Urological Malignancies cont’d from cover

The system developed composed of a gas chromatography column coupled to a metal-oxide gas sensor (GC-sensor) and a computer algorithm or pipeline. The pipeline involves chromatogram alignment, data transformation and feature selection algorithms in order to identify the features that best differentiate the medical condition. Scientists at the University of Liverpool (UK; www.liverpool.ac.uk) working with colleagues from other British institutions carried out a pilot study that included 155

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men presenting to urology clinics. Of this group, 58 were diagnosed with prostate cancer, 24 with bladder cancer and 73 with hematuria or poor stream without cancer. Aliquots of 0.75 mL of fresh urine were stored in septum-topped glass headspace vials (Supelco, Sigma Aldrich; Dorset, UK; www. sigmaaldrich.com) and frozen at −20 °C. The gas chromatography sensor system is known as the Odoreader. The GC-sensor was composed of a Clarus 500 gas chromatography (GC) oven (Perkin Elmer, Waltham, MA, USA; www.perkinelmer.com)

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fitted with a commercially available capillary column. The injection port of the GC was fitted with a 1 mm quartz liner and heated to a temperature of 150 °C. The volatile organic compounds (VOCs) present in the headspace of the urine mixture are passed through the GC, where they are separated according to their molecular weight, boiling point, polarity and chemical functionality.

The team found significant separation between prostate cancer and control samples, bladder cancer and controls and between bladder and prostate cancer samples. For prostate cancer diagnosis, the GC/ support vector machine (SVM) system classified samples with 95% sensitivity and 96% specificity after leave-one-out cross-validation (LOOCV). For bladder cancer diagnosis, the SVM reported 96% sensitivity and 100% specificity after LOOCV, while the double cross-validation reported 87% sensitivity and 99% specificity, with SVM showing 78% and 98% sensitivity between prostate and bladder cancer samples.

Chris S. J. Probert, MD, FRCP, FHEA, a professor of gastroenterology, and the senior author of the study, said, “There is an urgent need to identify these cancers at an earlier stage when they are more treatable as the earlier a person is diagnosed the better. After further sample testing the next step is to take this technology and put it into a user-friendly format.

With help from industry partners we will be able to further develop the Odoreader, which will enable it to be used where it is needed most; at a patient’s bedside, in a doctor’s surgery, in a clinic or walk-in center, providing fast, inexpensive, accurate results.”

The study was published on February 11, 2016, in the Journal of Breath Research.

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NuQ Blood Assay CE-Marked For Colorectal Cancer Detection blood-based diagnostic assay for detection of colorectal cancer has received Conformité Européenne (CE) marking. The test utilizes a proprietary technology platform that identifies and analyses fragments of chromosomes, called nucleosomes, circulating within the blood for the presence of epigenetic cancer signals. The announcement of the CE marking follows the presentation earlier this month of interim data of a 4,800-subject trial, which demonstrated that the NuQX001S (VolitionRx Limited; Namur Belgium; www.volitionrx.com) blood tests detected 81% of colorectal cancers at 78% specificity equally well for both for early- and late-stage cancers, as well as 63% of potentially pre-cancerous adenomas and 67% of high-risk adenomas, the most likely to become cancerous. The NuQ test utilizes the Company’s proprietary Nucleosomics technology platform.

The Company plans to offer a commercial test consisting of a panel of four to six individual enzyme-linked immunosorbent assays (ELISA); it is currently conducting ongoing clinical trials and following the CE compliance process on further assays in order to refine the make-up of the panel and produce the highest accuracy detection rates. VolitionRx anticipates launching its panel of CE-Marked assays for clinical use in Europe during 2016.

Gaetan Michel, PhD, CEO of Belgian Volition SA, commented, “Our recent results showed that a panel test of four NuQ assays successfully detected both early- and late-stage cancer well, which is critical for improving five-year survival rates. Achieving the first CE mark for our NuQX001S diagnostic assay demonstrates VolitionRx’s clear commitment to deliver these first-class quality products to physicians and their patients.”

Cameron Reynolds, MBA, president and CEO of VolitionRx, said, “We are now able to sell this assay clinically in the 28 member states of the European Union, as well as Switzerland, Turkey, Iceland, Norway, and Liechtenstein, an area with a total population of nearly 600 million people including over 150 million of screening age.”

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Image: Nucleosomics Technology: The DNA in every cell is wound around protein complexes in a beads-on-a-string structure. Each bead is called a nucleosome. When cells die, the body breaks the DNA string up into individual nucleosomes, which are released into the blood (Photo courtesy of VolitionRx Limited).

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HEMATOLOGY ANALYZER

BRAF MUTATION TEST

77 Elektronika

Beckman Coulter

Biocartis

The UriSed 3 uses brightfield and phase contrast microscopy to provide advanced visualization and recognition of formed elements in urine samples. It improves differentiation of hyaline casts, RBCs, crystals, yeast and overall diagnostic performance in central screening and specialist labs.

The DxH 500 is an open-vial instrument offering a throughput of up to 60 samples per hour. The system has been specifically designed for low-volume hematology workloads and to promote rapid specimen turnaround and reduce patient wait times in small- and medium-sized clinics.

The BRAF mutation test allows detection of BRAF mutations directly from FFPE tissue sections in 90 minutes with less than 2 minutes of hands-on time.

The test is performed on the Idylla RT PCR-based molecular system that offers fast and easy access to high-quality biomarker data.

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Novel Molecular Tool Detects Asymptomatic Malaria-Infected Individuals alaria control programs aiming at decreasing local transmission and achieving preelimination status require proper detection of Plasmodium parasites in the peripheral blood, both in febrile

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patients and asymptomatic carriers.

Asymptomatic carriers, representing the human reservoir contributing to the transmission of the parasites, generally have much lower parasite densities compared to symptomatic

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individuals, at detection thresholds of less than 200 parasites/ÎźL, below which the standard diagnostic tools such as microscopy and rapid diagnostic tests (RDTs) become less reliable.

A team of collaborating scientists led by those at Medical Research Council Unit (Banjul, The Gambia; www.mrc.gm) collected blood from 341 subjects whose median age was 9 years (range 1 to 68 years), and screened for malaria. From a single finger prick, blood samples were collected for RDT, thick blood film (TBF) and dried blood spots (DBS). The RDTs were read immediately in the field while the DBS and microscopy slides were taken to the field station at the end of each day for further processing. A novel molecular tool, the loop-mediated isothermal amplification (LAMP), targeting the apicoplast genome of Plasmodium falciparum was evaluated for the detection of asymptomatic malaria-infected individuals.

P. falciparum malaria prevalence was 37% (127/341) as detected by LAMP, 30% (104/341) by microscopy and 37% (126/341) by the SD Bioline Malaria Antigen P.f RDT (Standard Diagnostics, Inc.; Yongin-si, Republic of Korea; www.standardia. com). Compared to the reference polymerase chain reaction (PCR) method, sensitivity was 92% for LAMP, 78% for microscopy, and 76% for RDT; specificity was 97% for

LAMP, 99% for microscopy, and 88% for RDT. Turn-around time for the entire LAMP assay was approximately three hours and 30 minutes for an average of 27 Âą 9.5 samples collected per day, compared to a minimum of 10 samples an hour per operator by RDT and over eight hours by microscopy.

The authors concluded that with a shorter turn-around-time and high throughput processing, LAMP results would be available much faster than by microscopy and more reliably than with RDT, supporting the use of this diagnostic test for mass screening and treatment (MSAT) or focused screening and treatment (FSAT) campaigns. The apicoplast genome that this novel LAMP assays targets is unique to the parasite, thus ensuring high specificity. The study was published on October 9, 2015, in the Malaria Journal.

Image: A visualization of loop-mediated isothermal amplification (LAMP) reaction in a 96-well plate format showing color differences between positive and negative samples (Photo courtesy of the Medical Research Council Unit, Gambia).

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PRODUCT NEWS RAPID DIAGNOSTIC TEST

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CHROMOGENIC ASSAY

CENTRIFUGE

Coris BioConcept

Diagnostica Stago

EKF Diagnostics

The OXA-48 rapid test is designed for in vitro identification of Carbapenemase OXA-48-like in bacteria culture. Key advantages of the ready and easyto-use kit includes only 5 minutes hands-on time, 15 minutes reaction time, along with sensitivity and specificity of 100 percent.

The STA - ECA II is designed for measuring dabigatran (Pradaxa) concentration in plasma and is insensitive to lupus anticoagulants and heparin along with coagulation factor and fibrinogen levels.

It is intended for research use only, along with the associated calibrators and controls.

The Creamatocrit Plus is a mother’s milk fat and calories analyzer. This centrifuge with built-in tube reader provides a fast and accurate creamatocrit measure of mother’s milk and estimate of calories to help ensure that premature infants thrive. It is considered particularly useful in NICUs.

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Simplexa Direct Test Includes 53 New Virus Strains he Simplexa test kit for select virus strains can detect a total of 92 influenza and respiratory syncytial virus (RSV) virus strains, more than any other officially cleared molecular test kit.

These include all four influenza strains that global health experts recommend be included in vaccines during the northern hemisphere’s 2015-2016 influenza season: A/Switzerland/9715293/2013 (H3N2)-like virus; A/California/7/2009 (H1N1)like virus, B/Phuket/3073/2013-like virus, and B/Brisbane/60/2008-like virus.

In addition, the 46 new influenza strains include 20 avian influenza A and two swine influenza virus strains. These may be increasingly important to detect, as avian and swine influenza viruses can carry over into human populations. Influenza occurs globally, affecting an estimated 5% to 10% of adults and 20% to 30% of children, according to the World Health Organization (Geneva, Switzerland; www.who.org) statistics. Most seasonal flu activity

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in the Northern Hemisphere occurs between October and May, with peak season in the USA is between December and February.

The Simplexa Flu A/B & RSV Direct kit (Quest Diagnostics; Madison, NJ, USA; www.quest diagnostics.com) on the 3M Integrated Cycler (Focus diagnostics; Cypress, CA, USA; www.focusdx. com) is a real-time reverse transcriptase polymerase chain reaction (RT-PCR) molecular test for the in vitro qualitative detection and differentiation of Influenza A virus, Influenza B virus, and respiratory syncytial virus (RSV) ribonucleic acid (RNA) in nasopharyngeal swabs from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors.

Classified as Clinical Laboratory Improvement Amendments (CLIA) moderate complexity, the test can report results in about an hour through a proprietary process that eliminates nucleic acid extraction, a time consuming technique typically employed by molecular tests. The tests have received

from the US Food and Drug Administration (FDA, Silver springs, MD, USA; www.fda.gov) 510(k) initial clearance for combined molecular detection of influenza A, B and respiratory syncytial virus. Additional Simplexa tests aid in the detection and differentiation of influenza A, influenza B and RSV, Clostridium difficile, Group A Strep and Herpes simplex Virus (HSV) 1 and 2.

Image: The 3M integrated cycler with assay kits (Photo courtesy of Focus Diagnostics).

Cancer DNA in Blood Helps Personalize Liver Cancer Treatment iver cancer tumor specimens are difficult and sometimes dangerous to obtain, and noninvasive methods are required to assess cancer progression and characterize underlying genomic features. The detection of DNA released by damaged cancer cells, called circulating tumor DNA (ctDNA), in serum before surgery could predict the recurrence of cancer and its metastatic spread through the body in patients with an advanced form of the most common type of liver cancer.

Scientists at the Hiroshima University (Japan; www.hiroshima-u.ac.jp) and their colleagues analyzed 46 patients with hepatocellular carcinoma who underwent hepatectomy or liver transplantation and for whom whole-genome sequencing data was available. They designed personalized assays targeting somatic rearrangements of each tumor to quantify serum ctDNA. Exome sequencing was performed us-

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ing cell-free DNA paired primary tumor tissue DNA from a patient with recurrent liver cancer after transcatheter arterial chemoembolization (TACE).

The team used a chemiluminescent immunoassay (Fujirebio; Tokyo, Japan; www.fujirebio.com) and chemiluminescent enzyme immunoassay (Abbott Laboratories, Abbott Park, IL, USA; www. abbott.com) to analyze α-fetoprotein (AFP) and desγ-carboxy prothrombin (DCP), respectively. Thresholds for AFP and DCP abnormalities were defined as 10 ng/mL and 30 mAU/mL, respectively. Cellfree DNA was extracted from 100 μL of preoperative serum by the SMI-TEST (Genome Science Laboratories, Tokyo, Japan; www.gandgscience.co.jp).

Real-time polymerase chain reaction (PCR) analysis was performed on samples that tested positive in the detection assay and for which serial serum samples were available. PCR was performed using the

Mx300P System (Applied Biosystems, Foster City, CA, USA; www.appliedbiosystems.com).

The investigators were able to identify 25 common mutations in samples of cell-free DNA, which includes DNA from both normal cells and cancer cells, and DNA from tumors themselves. Furthermore, 83% of mutations identified in the tumor tissues could be detected in the cell-free DNA. They found ctDNA in seven patients and they say that ctDNA has the potential to be a noninvasive way of studying the genetic rearrangements that a cancer has undergone.

This information could help doctors provide targeted therapy specific to a patient’s cancer. They also demonstrated that the level of serum ctDNA reflected the treatment effect and the progression of hepatocellular carcinoma (HCC). The study was published in the September 2015 issue of the journal Cellular and Molecular Gastroenterology and Hepatology.

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LabMedica International

Cytokine Serum Levels Increased in Osteoporosis nterleukin 31(IL-31) is a proinflammatory cytokine mediating multiple immune functions, whose involvement in a wide range of diseases, such as atopic dermatitis, inflammatory bowel diseases and cutaneous lymphomas.

Osteoporosis is a systemic skeletal disease characterized by decreased bone mass and microarchitectural deterioration of bone tissue and an excessive bone resorption and/or an inadequate bone formation results in a subsequent increase in bone fragility and susceptibility to fractures.

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Blood Test Could Match and Monitor Cancer Patients and Treatment esearchers have found that new generation sequencing (NGS) of circulating cell-free DNA (cfDNA) in blood plasma could help successfully pair cancer patients with the most suitable therapy and track tumor progression to assess treatment effectiveness.

Genetic monitoring of a patient’s tumor provides information on how the cancer is changing and whether it is becoming resistant to treatment.

Researchers and clinicians from The Institute of Cancer Research (London, UK; www.icr.ac.uk) and The Royal Marsden Hospital (London, UK; www. royalmarsden.nhs.uk) examined genetic mutations in cfDNA extracted from 150 plasma samples from 39 patients, with late-stage cancer of known tumor mutation, who were participating in early-phase clinical trials of targeted drugs. Treatments targeted mainly the PI3K-AKT-mTOR pathway or MEK. This is the first study where a blood test has been used in this way during clinical trials of targeted drugs, showing that targeted-NGS of cfDNA has potential to simply and quickly monitor response to targeted therapy.

Tumor biopsies are generally taken only at the beginning of treatment, so information is unavailable about how tumor genetic makeup is changing in response to treatment. Blood testing could provide realtime updates, as well as help doctors identify patients suitable for clinical trials of new drugs.

“Tumors and the gene faults that drive them are unique and constantly evolving. It’s crucial that we understand these changes so doctors can choose the best treatments for each patient,” said study leader Prof. Johann de Bono, from the Institute of Cancer Research, London and The Royal Marsden, “We need to do more research, but this approach could have a huge impact on how we make treatment decisions, also potentially making diagnosis and treatment quicker, cheaper, and less invasive.”

“Blood tests like these are the future of cancer treatment and this study proves that they can work in practice – helping us to diagnose, analyze, and monitor tumors more easily,” said Dr. Kat Arney, science information manager, Cancer Research UK (London, UK; www.cancerresearchuk.org), “Thanks to research like this we’re developing new ways to shake the genetic foundations that underpin cancer and save more lives.” The study, by Frenel et al., was published October 15, 2015, in the journal Clinical Cancer Research.

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Scientists at the University of L’Aquila (L’Aquila, Italy; www.univaq.it) enrolled in a study 56 postmenopausal females with osteoporosis whose mean age 65.39 ± 9.68 years and 26 age-matched healthy postmenopausal women as controls. Bone mineral density (BMD) measurements were performed by using calcaneal quantitative ultrasound (QUS) technique, confirmed at the lumbar spine and hip by dual energy X-ray absorptiometry (DXA). Both patients and controls were divided according to age: less or more than 65 years, and disease severity: T-score levels and presence of fractures. The IL-31 protein levels were evaluated using a standard sandwich enzyme-linked immunosorbent assay (ELISA) kit (USCN Life Science; Houston, TX, USA; www.uscnk.com). The absorbance was measured at 450 nm by a microspectrophotometer model 340 ATTC (SLT Laboratory Instruments; Salzburg, Austria; www.tecan.com) and the results were expressed as pg/mL with the minimum de-

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tectable level of IL 31 less than 5.5 pg/mL. Osteoporotic patients exhibited elevated levels of serum IL-31 compared with healthy controls and IL31 expression was higher in over 65 years old patients compared to age-matched controls. In younger subjects no statistically significant differences were detected between patients and controls. No statistically significant differences were found between IL31 levels in patients affected by mild compared to severe osteoporosis neither between fractured osteoporotic women and those without fractures.

The authors concluded that there was an increase of IL-31 serum levels in postmenopausal women with decreased BMD. Although they did not reflect the severity of osteoporosis and/or the presence of fractures, they clearly correlated with age, as reflected by the higher levels of this cytokine in aged patients. The study was published on October 8, 2015, in the journal BMC Immunology.

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Respiratory Pathogen Diagnostic Panel Now Certified for Europe uropean certification (CE marking) has been granted for a diagnostic panel that incorporates tests for 21 clinically relevant viral and bacterial respiratory pathogens into a single closed microtiter plate well. The wide range of the Luminex Corporation (Austin, TX, USA; www.luminexcorp.com) NxTAG respiratory pathogen panel also includes such atypical bacteria as Chlamydophila pneumoniae, Mycoplasma pneumoniae, and Legionella pneumophila.

The NxTAG panel was designed for use with the Luminex MAGPIX instrument, which operates with fluorescent markers and magnetic microbeads. Each sample to be tested requires only minutes of handson time with no upstream reagent preparation. Simplified workflow allows extracted samples to be added directly to pre-plated, lyophilized reagents.

The wells are then sealed and ready for closed tube

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amplification and subsequent detection using the Luminex MAGPIX instrument. Innovative tube strip design offers laboratories the flexibility to manage variable sample demand by processing a single sample or up to as many as 96 samples per run, without wasting consumables or reagents, or the need to have full batches. Total turnaround time is just over three hours for 96 samples.

Onboard SYNCT Software provides a comprehensive approach to data analysis and reporting, and enables the NxTAG respiratory pathogen panel to integrate easily into any laboratory setting.

“As a leader in multiplexed solutions, we are excited to launch the next generation NxTAG Respiratory Pathogen Panel which delivers expanded coverage and a simple closed tube workflow, combined with the throughput and quality of results established by the xTAG Respiratory Viral Panel,” said

Thomas Pracht, Managing Director, EMEIA (Europe, Middle East, India, and Africa), at Luminex Corporation.

Image: The NxTAG respiratory pathogen panel simultaneously detects 21 respiratory pathogens in a single closed tube system (Photo courtesy of Luminex).

Test Predicts Whether Breast Cancer Metastasizes to the Brain omen can live for years with breast cancer that has begun to spread around the body, but the exception is when the cancer spreads to the brain, which usually indicates a woman is in her last few months of life.

The molecular chaperone αB-crystallin is expressed in estrogen receptor, progesterone receptor and human epidermal growth factor receptor-2 ‘triple-negative’ breast carcinomas and promotes brain and lung metastasis.

An international team of scientists led by those at University of British Columbia, (Vancouver, BC, Canada; www.ubc.ca) analyzed 969 breast cancer tumors which ultimately spread, or metastasized, to new sites in the body, from a database of almost 4,000 breast cancers from the British Columbia Can-

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cer Agency (BCCA) and 141 had spread first to the brain. The BCCA cohort includes 3,987 formalinfixed paraffin-embedded specimens from female patients with newly diagnosed, invasive breast cancer referred to BCCA from 1986 to 1992 that were used to construct large tissue microarrays (TMA) linked to detailed clinicopathological data and long-term outcomes with a median follow-up of 12 years.

TMAs were constructed from tissue blocks and αB-crystallin protein expression was evaluated by immunohistochemistry (IHC) using a mouse monoclonal antibody (Enzo Life Sciences; Farmingdale, NY, USA; www.enzolifesciences.com). Tumors were considered positive for αB-crystallin if there was any staining above background levels. The αBcrystallin protein expression was scored by a pathol-

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ogist who was blinded to clinical outcomes. Samples with less than 50 tumor cells present in the TMA core were excluded from the analysis and the TMAs were digitally scanned.

In the 855Met data set, αB-crystallin gene (CRYAB) expression was an independent predictor of brain as the first distant site of relapse. In the BCCA series, αB-crystallin protein expression was an independent prognostic marker of poor breast cancer-specific survival. Among patients with metastases, αBcrystallin was the strongest independent predictor of brain metastasis and the only independent predictor of brain as the first site of distant metastasis. Expression of αB-crystallin was also associated with worse survival. The study was published on October 21, 2015, in the journal npj Breast Cancer.

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Study Validates Use of Noninvasive Test for Defective Fetal Chromosomes German biomedical company has reported the successful validation of its qPCR (quantitative real-time PCR)-based noninvasive test for fetal genetic abnormalities such as trisomy 21 (Down’s syndrome).

LifeCodexx AG (Konstanz, Germany; http:// lifecodexx.com) recently announced that its qPCRbased PrenaTest had been successfully validated in a study of nearly 700 samples of maternal blood.

Starting from the ninth week of pregnancy, the PrenaTest is able to determine trisomy 21, trisomies 21, 18, and 13, as well as gonosomal aneuploidies (Turner, triple X, Klinefelter, and XYY syndromes), in blood samples from expectant mothers at risk for fetal aneuploidies. If desired, the gender of the child may also be determined. This assay acts as a supplement to the noninvasive prenatal diagnostic techniques already in use, but – in comparison with in-

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vasive examination methods – it does not involve the risk of procedure-related miscarriage.

The test method of the PrenaTest is based on the analysis of cell-free DNA (cfDNA) in the pregnant woman’s blood. The cfDNA is present in fragments and freely circulates in the maternal blood.

In addition to maternal cfDNA, the blood also contains approximately 2%–40% (on average approximately 10%) cell-free fetal DNA (cffDNA). The cffDNA essentially comes from the cytotrophoblast, that is, from placental cells of the growing embryo and is thus of extra-embryonic origin.

It develops through apoptosis and necrosis of the trophoblast cells and is continually excreted into the pregnant woman’s bloodstream. The lifespan of the DNA fragments is about two hours. Within a few hours after birth of the child, the cffDNA is no longer detectable in the mother’s blood. With the PrenaTest, the cffDNA in the maternal blood

is used to determine whether there is a chromosomal imbalance for a particular chromosome to thus determine a corresponding chromosomal disorder in the unborn child. Prenatal tests based on this method are known as noninvasive prenatal testing (NIPT).

The data generated by the clinical validation study was presented on the occasion of the FMF (Fetal Medicine Foundation) Advances Course held December 5-6, 2015, in London (United Kingdom).

“For the first time leading medical associations in Europe recently recommended that NIPT can now be used as primary screening for fetal trisomy 21 in all pregnant women of any age or risk,” said Dr. Wera Hofmann, CSO of LifeCodexx AG. “Due to its rapid turnaround time and low cost, our qPCRbased PrenaTest will be the ideal noninvasive prenatal test which will allow doctors to implement the new recommendations into their clinical routine.”

Rapid Molecular Host-Response Assay May Improve Diagnosis of Sepsis microarray assay that measures classifier RNA transcript biomarkers in blood may help quickly differentiate sepsis from infection-negative systemic inflammation (INSI) in critically ill patients, according to a new study.

A team led by Leo McHugh, PhD, of Immunexpress Inc. (Seattle, WA, USA; www.immunexpress. com), reports the discovery and validation of a molecular classifier consisting of 4 RNA transcripts, SeptiCyte Lab, which in several selected patient cohorts was able to diagnose sepsis more accurately than procalcitonin or clinical parameters, and more quickly than blood culture.

Dr. McHugh and colleagues used microarray analysis to measure RNA expression levels of thousands of genes in blood samples from a cohort of 74 patients with sepsis and 31 post-surgical patients with INSI, thereby identifying the four genes (CEACAM4, LAMP1, PLA2G7, and PLAC8) that comprise the SeptiCyte Lab classifier. The researchers further validated the classifier in 5 additional cohorts from an independent Netherlands-based study, consisting of a total of 345 patients. In these cohorts, SeptiCyte Lab, which produced a result within 4–6 hours, was significantly better at differentiating patients with sepsis from patients with INSI than was procalcitonin or clinical parameters available to a clinician within 24 hours of ICU admission. In the validation cohorts, using a specified threshold SeptiCyte Lab was able to correctly identify 90% of patients with sepsis, with a specificity of 60%.

Validation in the Netherlands-based cohorts is preliminary, so larger clinical studies are needed that include patients from diverse geographic and hospital care settings. The researchers suggested that this assay could become a clinically useful tool: “In combination with clinical parameters and clinical judgment, SeptiCyte Lab may provide physicians with enhanced confidence in therapeutic decision-making for patients with systemic inflammation.”

The study, by McHugh L et al., was published December 8, 2015, in the journal PLOS Medicine.

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PRODUCT NEWS DIAGNOSTIC SOLUTION

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URINARY ANTIGEN TEST

BENCHTOP CENTRIFUGE

Savyon Diagnostics

Statens Serum Institut

Thermo Fisher Scientific

The CAS100 integrates sample prep, NA extraction, multiplexed amplification and detection, as well as data analysis. The user-friendly system is a fully automated sample-to-answer platform capable of detecting up to 100 targets for each sample within 90 minutes.

The ImmuView S. pneumoniae and L. pneumophila is a two-in-one rapid lateral flow test for qualitative detection of S. pneumoniae and L. pneumophila serogroup 1 in human urine samples. Key features include simple handling, and results in as little as 15 minutes.

The Medifuge is designed for simple operation, and features a large, brightly lit display with intuitive controls and a fast one-click closure. The four customizable programs allow users to quickly run routine protocols, while three deceleration profiles are designed to provide optimal separation.

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Noninvasive Prenatal Screening Test Validated for Trisomies iagnosis of fetal aneuploidies relies on invasive testing by chorionic villous sampling (CVS) or amniocentesis in pregnancies that are identified by screening to be at highrisk for such aneuploidies.

A recently developed cell-free DNA (cfDNA) test which uses the Ion Proton sequencing platform and an algorithm that determines the relative number of chromosomal copies enabling detection of fetal trisomies has been assessed.

Scientists at King’s College Hospital (London, UK; www.kcl.ac.uk) carried out a nested casecontrol study of stored maternal plasma from 242 singleton pregnancies at 11 to13 weeks’ gestation, including 201 with euploid fetuses, 35 with Down’s syndrome (trisomy 21), 4 with Edwards’ syndrome (trisomy 18), and 2 with Patau’s syndrome (trisomy 13). A noninvasive prenatal

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screening test (NIPT) was used to analyze the blood samples.

The samples were analyzed with the IONA test and IONA Software (Premaitha Health plc; Manchester, UK; www.premaitha.com). All 242 samples were processed with the IONA test that measures the relative amount of chromosomes 21, 18, and 13 in the maternal plasma sample to calculate a likelihood ratio to predict the presence of a trisomy. This data is coupled with the background risk associated with maternal age to determine an adjusted probability of the fetus having a trisomy of chromosome 21, 18, or 13.

Of the 242 samples; 35 were trisomy 21, 4 were trisomy 18, and 2 were trisomy 13, and therefore the IONA test detected 100% of all trisomies. This nested case-control study has demonstrated that in pregnancies considered by

the combined test to be at high-risk for trisomies 21, 18, or 13, cfDNA testing of maternal plasma at 11 to 13 weeks’ gestation by the IONA test and IONA software, correctly identified all trisomic pregnancies with no false positives.

The study was published online on September 21, 2015, in the Journal of Ultrasound in Obstetrics and Gynaecology.

Image: The IONA test for the screening plasma for trisomies 21, 18 or 13 (Photo courtesy of Premaitha Health).

Analysis of Circulating DNA Predicts Prostate Cancer’s Development of Drug Resistance nalysis of prostate cancer DNA circulating in the bloodstream identifies a mutation that indicates whether the tumor will become resistant to the drug-of-choice abiraterone, and enables the physician to choose an alternative treatment.

Androgen receptor (AR) gene aberrations are rare in prostate cancer before primary hormone treatment but emerge with castration resistance; therefore, determination of AR gene status using a minimally invasive assay would have broad clinical utility.

Towards this end, investigators at the Institute of Cancer Research (London, United Kingdom; www.icr.ac.uk) developed a targeted next-generation sequencing approach amenable to plasma DNA, which covered all AR coding bases and genomic regions that have been linked to prostate cancer.

The investigators sequenced 274 plasma samples from 97 castration-resistant prostate cancer pa-

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tients treated with abiraterone at two institutions.

They controlled for normal DNA in patients’ circulation and detected a sufficiently high tumor DNA fraction to quantify AR copy number state in 217 samples (80 patients).

Results revealed that patients with a specific mutation or an increase in the number of copies of the AR gene were 7.8 times less likely to have a reduction of more than 90% in their PSA (prostate specific antigen) levels, a widely used test to monitor the response of prostate cancer to treatment. The study also found that in about 15% of men given abiraterone who did not have either genetic aberration before starting treatment, it was acquired as resistance appeared and the drug stopped working. The mutation was detectable in the bloodstream several months before patients developed any physical symptoms.

Senior author Dr. Gerhardt Attard, clinician scientist at the Institute of Cancer Research, said, “The discovery of abiraterone was an important

step forward for patients with advanced prostate cancer, but we know it does not work for all men, and we have been searching for a marker that will tell us in advance which men will benefit. We are delighted to have developed a test that appears to predict very accurately whether a patient will respond to abiraterone, and that it can be performed on blood samples – removing the need to take a biopsy. We are now planning a clinical trial involving up to 600 men in which we aim to prospectively show that men who are positive with our test have significantly greater benefit from chemotherapy in preference to abiraterone or similar drugs.

Additionally, looking at tumor DNA in the blood of patients could potentially give us an overall picture of why the cancer is progressing all over the body, unlike a biopsy that only tells us about the area sampled.”

The study was published in the November 4, 2015, online edition of the journal Science Translational Medicine.

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LabMedica International

Commercial Assay Aids Physicians in Tamoxifen Drug Monitoring laboratory-developed test could help assess levels of several tamoxifen drug metabolites in a blood specimen which is important as five years of therapy with tamoxifen has been the standard of care for women with early stage, estrogen-receptor-positive (ER+) breast cancer following “curative” surgery.

Tamoxifen, taken for five years, reduces the risk of developing invasive breast cancer by about 50% in postmenopausal women who are at increased risk of getting the disease. However, compliance is an issue and patients could be further helped from precise prescribing as side effects from Tamoxifen are known to include mood swings, depression, and loss of libido, cataracts,

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Blood Cell Count Performed at Bedside With Innovative Biochip

blood clots, strokes, bone loss and the increase risk of endometrial and uterine cancer.

Medical experts from Quest Diagnostics (Madison, NJ, USA; www.questdiagnostics.com) show how the lab-developed test could help assess levels of several tamoxifen drug metabolites in a blood specimen. The scientists evaluated the blood serum from 155 women who were on 20 mg/day tamoxifen for more than six months. The patient population exhibited a wide range of concentrations of tamoxifen and its metabolites during therapy, reflecting individual differences in the ability to metabolize the drug.

The test is based on a tandem mass spectrometry, (LC-MS/MS) a technique used by world-class laboratories to measure hormones and vitamin D, the test allows physicians, for the first time, to employ a commercially available therapeutic drug

monitoring approach for their tamoxifen-treated patients. The test may also help physicians assess noncompliance with tamoxifen therapy, a common problem given side effects such as weight gain or loss.

Nigel Clarke, PhD, coauthor and a senior scientific expert responsible for technology innovation for Quest Diagnostics, said, “When people think of personalized medicine or precision medicine they often think of genetic testing to assess a drug against a gene variant. But a growing area in personalized medicine is the use of qualitative enzyme or drug metabolite testing to assess the biological impact of a drug rather than the indirect influence of genes.” The study was presented on December 11, 2015, at the San Antonio Breast Cancer Symposium held in San Antonio (TX, USA; www.sabcs.org).

here is a great need for an automated, portable point-of-care blood cell counter that could yield results in a matter of minutes from a drop of blood without any trained professionals to operate the instrument.

Expensive hematology analyzers are currently used as a gold standard for acquiring complete blood cell counts (CBCs) and for nearly all CBCs performed today, the patient must travel to either a hospital with a large laboratory or to a centralized laboratory testing facility.

Scientists at the University of Illinois at UrbanaChampaign (UIUC; Champaign, IL, USA; www. illinois.edu) developed microfluidic biochips capable of a partial CBC using only a drop of whole blood. Total leukocyte and their 3-part differential count are obtained from 10 mL of blood after onchip lysing of the red blood cells (RBCs) and counting of the leukocytes electrically using microfabricated platinum electrodes. For RBCs and platelets, one mL of whole blood is diluted with phosphate buffered saline (PBS) on-chip and the cells are counted electrically. The total time for measurement is under 20 minutes.

The team is already developing a portable prototype of the cell counter. The base unit of the reader will likely be hand-held and will take cartridges about the size of a credit card. They estimate the cost of a test will be around USD 10 instead of the USD 100 that a current test costs. The technology is scalable and the team also plans to investigate using it in other areas, such as animal diagnostics, blood transfusion analysis, and blood cell counting for managing chemotherapy treatments.

Umer Hassan, PhD, the first author of the study and an expert in bioelectronics, said, “There is huge potential for commercializing the technology and the translation of our technology will result in minimal to no experience requirement for device operation. Even, patients can perform the test at the comfort of their home and share the results with their primary care physicians via electronic means too.”

The study was published on December 11, 2015, in the journal Technology.

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PRODUCT NEWS URINE ANALYZER

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LAB IMAGING SYSTEM

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Adaltis

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The LabUMat features automated test tube handling and test strip dipping with flexible, customized testing, and reporting options. It has a color touch screen and is ideal for high volume urine test strip reading in medical labs.

The Hemo One offers extra diabetes diagnostics capabilities, featuring up to 25 positions including samples, calibrators, and QCs. It provides the first result after 10 minutes, followed by one result every minute, making it suitable for diabetic centers, doctor offices, and laboratories.

The CellaVision DM1200 automatically captures digital images of cells from blood smears and body fluid preparations for routine hematology testing.

With a loading capacity of 12 slides and approximately 20 slides throughput/hr, it is suitable for both large- and medium-sized labs.

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System Portfolio Includes High Medical Value Virology Assays ew commercial virology assays offer the latest generation of performance with dual target technology for Human immunodeficiency virus 1 (HIV-1) and dual probe technology for Hepatitis C virus (HCV).

These new molecular diagnostic assays increase the available menu on the cobas 4800 System, further improving efficiency and flexibility that allows laboratories to deliver results for rapid clinical decisions in countries accepting the Conformité Européenne (CE) marking.

All of the new virology assays can run simultaneously on the cobas 4800 System (Roche Molecular Diagnostics; Basel, Switzerland; http://molecular. roche.com) with optimized sample processing volumes for streamlining workflow that increases flexibility for patient sample management. With these additions, the cobas 4800 System now has a menu of 12 high medical value in vitro diagnostic (IVD) assays, making it the ideal solution for a highly effi-

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cient laboratory.

The three new virology assays can run simultaneously on the cobas 4800 System with two different sample processing volumes for HIV-1 and HCV (200 μL and 400 μL) and only 400 μL for HCV genotyping test (GT) streamlining workflow while increasing flexibility for patient sample management. The cobas HIV-1 is built upon the dual-target assay design and the test simultaneously amplifies and detects two separate regions of the HIV-1 genome, which are not subject to selective drug pressure, allowing for more reliable results to confidently and effectively quantify the amount of HIV-1 ribonucleic acid (RNA) in a patient’s blood.

The cobas HCV Genotyping is a highly accurate and sensitive real-time polymerase chain reaction (PCR)-based test for the qualitative identification of HCV genotypes 1 to 6 and genotype 1 subtypes a and b in human plasma or serum from individuals with chronic HCV infection. Identification of the in-

fecting genotype is required before a patient is prescribed antiviral therapy as response to treatment correlates to the HCV genotype. The cobas HCV employs a unique dual-probe approach to provide an extra layer of protection against mutations that can occur in the viral genome and is designed to accurately detect and quantify Hepatitis C virus ribonucleic acid (RNA) with state-of-the-art sensitivity in order to confirm active HCV infection or assess a patient’s response to antiviral therapy.

Image: The cobas 4800 is a fully automated sample preparation device, which amplifies and detects DNA targets using real-time polymerase chain reaction (PCR) (Photo courtesy of Roche).

Cancer-Associated Mutations Found in Patients with Unexplained Cytopenias atients with unexplained low blood counts and abnormally mutated cells who do not fit the diagnostic criteria for recognized blood cancers should be described as having clonal cytopenias of undetermined significance (CCUS).

Myelodysplastic syndromes (MDS) are clonal bone marrow disorders characterized by inefficient and dysmorphic hematopoietic differentiation, cytopenias of the peripheral blood, and increased risk of transformation to acute myeloid leukemia (AML).

Scientists at the Moores Cancer Center, (La Jolla, CA, USA; www.cancer.ucsd.edu) and their colleagues performed a prospective study to examine the frequency and types of mutations encountered in 144 patients with unexplained cytopenias. Patients had a complete medical history as well as screening tests that included a complete blood count with differential, iron studies, reticulocyte count, erythropoietin level, vitamin B12, and folate levels.

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Genomic DNA was extracted from the bone marrow aspirate samples and selected exons and flanking sequences of 22 myeloid genes were amplified by multiplex polymerase chain reaction (PCR). Libraries were created using a Fluidigm Access Array system (Fluidigm Corporation; South San Francisco, CA, USA; www.fluidigm.com). Amplicon libraries were split to be sequenced on the Illumina MiSeq platform (Illumina; San Diego, CA, USA; www.illumina.com) in duplicate. For all cases, assignment to the diagnostic group was performed centrally at Genoptix Medical Laboratory (Carlsbad, CA, USA; www.genoptix.com).

Based on bone marrow findings, 17% of the enrollees were diagnosed with MDS, 15% with idiopathic cytopenias of undetermined significance (ICUS) and some evidence of dysplasia, and 69% with ICUS and no dysplasia. Bone marrow DNA was sequenced for mutations in 22 frequently mu-

tated myeloid malignancy genes. Somatic mutations were identified in 71% of MDS patients, 62% of patients with ICUS and some dysplasia, and 20% of ICUS patients and no dysplasia. In total, 35% of ICUS patients carried a somatic mutation or chromosomal abnormality indicative of clonal hematopoiesis.

Rafael Bejar, MD, PhD, assistant professor of medicine and senior author of the study, said, “We don’t know to what extent patients who have low blood counts and mutations are at increased risk of developing an overt malignancy. We hope that by defining CCUS, future studies will follow these patients to learn what these mutations mean for their future as their genetically abnormal cells may represent early stages of subsequent blood cancers.” The authors concluded that CCUS is a more frequent diagnosis than MDS in cytopenic patients. The study was published on October 1, 2015, in the journal Blood.

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LabMedica International

Alzheimer’s Risk Genes Linked to Brain Atrophy wo genetic variants previously linked to Alzheimer’s disease (AD) have been more specifically tied to brain atrophy that is characteristic of the disease. A direct link has been found of common variants of two genes to atrophy in cortical and hippocampal regions of the brain, which are associated with memory and other key functions. It is also believed to be the first to link the atrophy to protein levels in the blood produced by the genes.

Neurobiologists at the Indiana University School of Medicine (Indianopolis, IN, USA; www.indiana.edu) and their colleagues conducted a study in 50 participants with no cognitive difficulties and 90 who had been diagnosed with mild cognitive impairment, a condition that is associated with increased risk of developing Alzheimer’s disease. All of the participants were 50 years or older. The team investigated the top nine genetic variants that have been associated with Alzheimer’s disease risk, not including the apolipoprotein E (APOe4) gene that has long been linked to increased risk for several characteristics of Alzheimer’s disease.

The team used magnetic resonance imaging tools to measure brain size and genetic analysis, the scientists looked for associations between the genetic variants and atrophy in the cortical and hipWORLD’S MEDICAL PRODUCT pocampal regions of the brain, which are established physical biomarkers of Alzheimer’s disease. Peripheral blood expression array data was obtained using the 1-million SNP Illumina Human Omni-Quad array and Illumina Human BeadChips (Illumina; San Diego, CA, USA; www.illumina.com). After explicit matching of cortical and hippocampal morphology they computed in 3D the cortical thickness and hippocampal radial distance measures for each participant.

The scientists found that just two genetic variants of the Membrane-Spanning 4-Domains, Subfamily A, Member 6A (MS4A6A rs610932) and the ATP-Binding Cassette, Sub-Family A (ABC1), Member 7 (ABCA7 rs3764650) were significantly associated with cortical and hippocampal atrophy.

Exploratory MS4A6A and ABCA7 peripheral blood expression analyses revealed a similar pattern of associations with cortical neurodegeneration.

Liana G. Apostolova, MD, the Barbara and Peer Baekgaard, professor of Alzheimer’s Disease Research and senior author of the study said, “We also found that the levels of the protein products of Connecting Buyers with these genes, circulating in the peripheral Suppliers Worldwide blood, were associated with the cortical and hippocampal atrophy. This finding Reach new sources of supply suggests that those results of gene expresIdentify latest products and technologies sion could become useful biomarker Send inquiries directly to suppliers blood tests for Alzheimer’s disease.” The Receive latest product alerts study was published online on November Chat live with suppliers 5, 2015, in the journal Neurobiology of Aging.

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Image: The single nucleotide polymorphism (SNP) Human Omni-Quad array (Photo courtesy of Illumina).

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LabMedica International May/2016

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The Stat Profile pHOx Ultra provides up to 20 critical care tests from one small, 210-microliter sample in two minutes. It allows up to 30 specific userdefined subsets (panels) to be created for patient populations such as pulmonary, surgical, pediatric or emergency care.

The QuikRead 101 consists of the instrument, accuracy dispenser, and reagent kits for in vitro diagnostic use. It produces quantitative or qualitative results and has been designed and calibrated for both photometric and turbidimetric measurements.

The STA-ECA II ecarin-based assay measures the anticoagulant effect of direct thrombin inhibitors. It is insensitive to lupus anticoagulant, heparin and variations in levels of coagulation factors and fibrinogen. Long onboard stability (3 days) and at 28°C (28 days) makes it ideal for lab use.

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Compounds Detected in Breath Samples Specific to Ovarian Cancer iagnosing cancer today usually involves various imaging techniques, examining tissue samples under a microscope, or testing cells for proteins or genetic material.

In search of safer and less invasive ways to tell if someone has cancer, analyzing breath and defining specific profiles of compounds in breath samples is under investigation, but translating these exhaled disease fingerprints into a meaningful diagnosis has required a large number of sensors, which makes them impractical for clinical use.

Chemical engineers at the Technion, Israel Institute of Technology (Haifa, Israel; www. technion.ac.il) and their colleagues developed a small breath-diagnostic array based on flexible gold-nanoparticle sensors for use in an “electronic nose.” Flexible sensors based on molecularly modified gold nanoparticles (GNPs) were inte-

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grated into a dynamic cross-reactive diagnostic sensing array.

Individual dynamic flexible sensor could selectively detect parts per billion (ppb) level VOCs that are linked with ovarian cancers in exhaled breath and discriminate them from environmental VOCs that exist in exhaled breath samples, but do not relate to ovarian cancer per se. Strain-related response successfully discriminated between exhaled breath collected from 43 volunteers, 17 of whom had ovarian cancer, with data from a single sensor being sufficient to obtain 82% accuracy, on breath samples irrespective of important confounding factors, such as tobacco consumption and comorbidities. The approach raises the hope of achieving an extremely simple, inexpensive, portable, and noninvasive diagnostic proce-

dure for cancer and other diseases. The study was published online on September 9, 2015, in the journal Nano Letters.

Image: A representation of breath sample analyses for the diagnosis of ovarian cancer (Photo courtesy of Technion).

Predisposing Gene Associated With Cowden Syndrome new gene has been discovered that is associated with Cowden syndrome, an inherited condition that carries high risks of thyroid, breast, and other cancers, and a subset of noninherited thyroid cancers.

Cowden syndrome (CS) is an underdiagnosed difficult-to-recognize autosomal-dominant disorder characterized by multiple hamartomas and an increased predisposition to breast, thyroid, endometrial, and other cancers and other non-neoplastic phenotypes that include macrocephaly and mucocutaneous findings.

Scientists at the Cleveland Clinic (Cleveland, OH, USA; http://my.clevelandclinic.org) and their colleagues subjected germline genomic DNA extracted from peripheral-blood leukocytes of the eligible proband to exome sequencing. Exome enrichment was performed, and subsequent 100 bp paired-end sequencing was performed with a HiSeq 2000 platform (Illumina, San Diego, CA, USA; www.

A

illumina.com). Mutations in candidate genes of interest were validated by polymerase chain reaction (PCR)-based region-specific mutation analysis through Sanger sequencing. Sequencing was performed in the forward and reverse directions with ABI 3730xl DNA Analyzers (Applied Biosystems; Foster City, CA, USA; www.appliedbiosystems.com).

Exome sequencing and targeted genotyping identified Sec23 homolog B, COPII coat complex component (SEC23B) as a candidate gene in a CS-affected family with predominant thyroid cancer. Further analyses uncovered that SEC23B mutations are present in up to 3% of unrelated Cowden syndrome patients and in 4% of patients with non-syndromic thyroid cancer. With up to 50% of Cowden syndrome patients testing negative for all known genetic mutations, the syndrome remains an under-diagnosed and difficult-to-recognize condition.

Patients with Cowden syndrome develop non-

cancerous growths, called hamartomas that can appear on the skin in mucous membranes and in the intestinal tract. Cowden syndrome predisposes individuals to several types of cancers, an 85% lifetime risk of breast cancer, a 35% risk for epithelial thyroid cancer, and increased risks of uterine, kidney and colon cancers as well. At least one in 200,000 people are affected by the disease.

Charis Eng, MD, PhD, the senior author of the study said, “This isn’t the first time we discovered novel genetic mutations in Cowden syndrome, but what was truly remarkable is that the SEC23B gene had been identified back in 2009 as the cause of a very rare type of anemia, but not cancer. Our data not only identified a novel cancer-predisposing gene, particularly in thyroid cancer, but also highlighted how cellular stress responses can be hijacked by cancer cells to promote their survival.”

The study was published on October 29, 2105, in the American Journal of Human Genetics.

LabMedica International May/2016

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Edited by Tahir Pillay MBChB, PhD, FRCPath(Lon), FCPath(SA) IFCC members may send news to: Tahir Pillay MBChB, PhD, Head, Dept of Chemical Pathology, Faculty of Health Sciences, University of Pretoria, Private Bag Bag x323, Arcadia, 0007, South Africa Tel: (27) 12 319-2116; Fax: (27) 328 6000; Email: enews@ifcc.org

NEWS

In Memoriam:

Global IFCC Community Mourns The Loss of Prof. Gérard Siest

by Dr. Bernard GOUGET, Chair, IFCC Nominations Committee; Chair, IFCC General Conference Madrid March 2016 t is with great sadness that we inform you of the death of our colleague Gérard Siest in Rome on April 9, 2016 at 80 years of age.

Gérard Siest was born May 13, 1936 in Hayange (Moselle). Receiving his degree in pharmacy in 1959, his Licence ès sciences in 1965 and his Doctorate in Pharmaceutical Science in 1966, as Professor at the Faculty of Pharmacy, he taught biochemistry from 1974 to 2006. His whole career was spent in Nancy.

Dr. Siest was Chairman of the Science Council of the Nancy I University biology and pharmaceutical Science Council from 1979 to 1990. He was Dean of the Nancy I biology and pharmaceutical science faculty from 1978 to 1982 and Vice-Chairman of the Nancy I University from 1979 to 1989.

He was elected to the French National Academy of Pharmacy as a national representative, becoming a member of the 2nd Section in 1995 and then the 3rd Section in 2011. He was also a member of the Belgian Academy of Medicine. He was a Knight of of the Order of the Academic Palms (1984) and Officer of the French National Order of Merit (1992).

He was the Director of the Center for Preventive Medicine in Vandoeuvre-lèsNancy (1968-2005). Starting in 1970 he initiated quality control for medical biology laboratories, which remains today a major activity with continuing training by the Association Biologie Prospective.

In Lorraine he was the founder and tirelesss organizer of the Biologie Prospective Colloquia in Pont à Mousson (1970--1996 and 2006), which brought together highly influential experts and attracted the entire international medical biology community. In Pont-à-Mousson's conference center of Abbaye des Prémontrés were born the theory of reference values; the reconciliation of the drug therapies, enzymology, biochemistry, epidemiology and pharmacogenetics of cardio-vascular disease; the beginnings of precision medicine, and new concepts in managing and organizing medical biology labs. These events changed the way people saw clinical biology and brought Dr. Siest international renown among medical biologists, manufacturers and people in healthcare generally.

The Pont-à-Mousson meetings took on a new life in Santorini, Greece, where they were arranged in collaboration with his wife, Prof. Sophia Viskivis, as the Biologie Prospective Santorini Conferences, devoted to personalized medicine and genetics and held under the auspices of the European Society of Pharmacogenomics and Personalised Therapy (ESPT), which he chaired from 2011 forward.

As Chairman of the French Clinical Biology Society (SFBC) in 1984-1985, he fostered numerous international collabo-

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IFCC OFFICE Via Carlo Farini 81, 20159 Milan, ITALY Tel: (39) 02-6680-9912 • Fax: (39) 02-6078-1846 E-mail: ifcc@ifcc.org • Web: www.ifcc.org Office Hours: 8.30-13.00 and 13.30-17.30 Staff Members: Paola Bramati, Silvia Cardinale, Silvia Colli-Lanzi

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LabMedica International May/2016

rations with medical biology societies in other nations. In this regard he set up a joint commission between the SFBC and Spain's SEQC concerning reference values, which was a precursor to uniform international standards and the establishment of reference laboratories. By getting national societies to spur each other on, he was able to develop joint international projects that enhanced the visibility of medical biology and its importance in the patient pathway. He sat on the board of direccont’d on page 26

Prof. Gérard Siest

News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information

NEWS cont’d from page 25

Global IFCC Community Mourns the Loss of Prof. Gérard Siest

tors of numerous international institutions.

His enthusiasm and forward thinking led him to chair the International Federation of Clinical Chemistry (IFCC) from 1991 to 1996. He established the notion of laboratory medicine, which he had added to the IFCC's motto. During this time, the International Federation saw its greatest growth in countries seeking membership. During his chairmanship, he established the technical secretariat in Nancy, he re-organized the IFCC structure by creating the Education and Management Division and the Congresses and Conference Divisions.He inspired the creation of the European Federation (FESCC) and the EC4. He formalized collaborations with WASPaLM and he finalized the agreements with COLABIOCLI and APFCB. He established also the link with IRMM for reference materials, Lastly, he helped a great many French people to join the IFCC. His reputation was critical to the IFCC's/ EFLM’s auspices of EuroMedLab Paris 2015.

His intense international activity brought him honorary memberships in a number of scientific societies and honorary doctorates from several universities. He was also a member of the European Medications Agency (EMA) in London.

He is the author of over 834 articles and dozens of books and directed several publications. His work was recognized in 27 prestigious awards from the most celebrated scientific institutions in 16 countries. He was managing editor of Clinical Chemistry and Laboratory Medicine (CCLM) from 1998 to 2009, turning it into a fixture of the international scientific world that would become the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM), published by Walter de Gruyter, In addition, he held many editorial posts including editor-in-chief of Drug Metabolism and Personalized Medicine (2010-2015), and member of the editorial board of Nutrition, Metabolism and Cardiovascular Disease (since 2004), Phar-

macogenomics (since 2005), Personalized Medicine (since 2005), Pharmacogenomics and Personalized Medicine: Advances and Applications (since 2010).

His personality was one-of-a-kind. Always he was an energetic, tireless and tenacious worker. As was clear in Madrid at the IFCC General Conference (March 1820, 2016), his mind was full of plans and projects. We have just lost a talented colleague and an irreplaceable, visionary person — extraordinary in so many respects — who inspired several generations of professionals.

He gave us a tremendous amount both in terms of science and of promoting a major discipline, medical biology and laboratory medicine.

We share the grief of those dear to him and of his very many friends and colleagues. Our thoughts and feelings are with his wife, his children and his family.

The religious ceremony was held on April 2O in Bernécourt 54700 (Meurthe et Moselle, Franc) Gérard, we shall not forget you!

IFCC Launches Charitable Foundation for Clinical Lab Development in Emerging Nations FCC was proud to launch the Foundation for Emerging Nations (FEN) at the General Conference in Madrid in March 2016. This short article aims to give readers information about the purpose and organisation of the FEN; how donations can be made; and how applications for project funding may be submitted.

Full details of the FEN may be found at www.ifccfoundation.org

Swiss Law by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).

What is the FEN? The FEN is a non-profit making Charitable Trust established in 2016 under

Why is the FEN important?

A high percentage of all clinical decisions are influenced by the results of

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What is the purpose of the FEN? “The Foundation is devoted to fund raising and to supporting programmes that help to improve the quality and delivery of laboratory medicine services, particularly in emerging nations.”

laboratory medicine investigations.

Consequently, patient safety and clinical outcomes are dependent on the quality of laboratory medicine services. In developed countries laboratory medicine services are of high quality, and most are accredited against an international standard. In emerging nations there is scope for improvement in the quality of laboratory medicine services but educational support is required.

What projects are suitable for funding by the FEN? The FEN is able to support projects in emerging nations that are organised by societies, groups or individuals, provided that the project will lead to an outcome that: can be assessed in terms of quality improvement, and/or; provides a baseline for local support to continue the project.

Projects shall be educational in nature and may occur at undergraduate or postgraduate level. Suitable projects will be in line with the Mission, Aims and Overall Strategic Direction of IFCC, although the FEN is not restricted to supporting projects nominated by IFCC Members. Examples of suitable projects are given at www.ifccfoundation.org What are the governance arrangements for the FEN? The FEN is governed in strict accordance with Swiss Charity Law, involving: An elected Board of Directors holding regular meetings with minutes; Annual report and independently audited accounts in Swiss Francs; Independent expert reviewers of project proposals.

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Who are the elected Members of the FEN Board of Directors?

The inaugural Board of Directors comprises five persons with extensive experience of laboratory medicine and/or the operation of Charitable Trusts in healthcare: Dr. Graham H Beastall (UK) Chair; Prof. Thomas Brinkmann (Ger-

many); Dr. Lucia Monaco (Italy); Prof.

Tomris Ozben (Turkey); Dr. Michelle Rossier (Switzerland) Who will provide financial support for the FEN? IFCC has provided ‘start-up’ finance for the FEN. Further sponsorship may be provided by: Other Charitable Trusts active in healthcare; Global commercial organisations active in healthcare; National or international organisations with an interest in education in health; Individual donors interested in improving patient safety in emerging nations.

How can donations be made to the FEN? Potential donors to the FEN are encouraged to contact the Chair of the Board of Directors (chair@ifccfoundation.org) to discuss their donation and how it may be used and acknowledged. All donations will be deposited into the FEN bank account, with the following details: Bank: Credit Suisse, Geneva, Switzerland; Account Name: IFCC Foundation for Emerging Nations; Swift code: CRESCHZZ12A; IBAN: CH33 0483 5158 8655 2100 0; Account number: 0251-1588655-21 How can an application for project funding from the FEN be made?

The application form may be downloaded from www.ifccfoundation.org.

The deadline for receipt of applications is 31 May 2016.

LabMedica International May/2016

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News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information

IFCC Committee of Evidence Based Laboratory Medicine (C-EBLM): A Profile

by Chris Florkowski, C-EBLM Chair, Canterbury Health Laboratories, Christchurch, NZ urrent full members include Chris Florkowski (NZ, Chair), Hernan Fares-Taie (Argentina), Karina Rodriguez-Capote (Canada), Julien Wills (France) and Annie Zemlin (South Africa), supported by corresponding members including Nuria Gimenez (Spain). Each member offers different

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skills as well as regional perspectives from around the globe.

Our overall objective is to promote the rational use of scarce laboratory resources for optimal healthcare outcomes by promoting the tools of EBLM into daily practice. In particular, we seek to raise the profile of labora-

IFCC Committee of Analytical Quality (C-AQ): A Profile he Committee of Analytical Quality (C-AQ) is part of IFCC’s Education and Management Division (EDC) whose mission is to provide IFCC members and the healthcare community with education relevant to Clinical Chemistry and Laboratory Medicine, directed at scientific, management and clinical issues. CAQ’s current members are Egon Amann (DE), David Grenache (US), Alexander Haliassos (GR), Annette Thomas (UK), and Graciela Velazquez (PY). In addition, there are 25 Corresponding C-AQ Members.

Within this framework, C-AQ promotes the education and training of laboratory professionals on international standards and practices of analytical quality. This includes, for example, Internal quality control procedures, external quality assessment schemes (proficiency testing programs), and Pre-analytical and Post-analytical concepts, besides others.

Educational and training needs of emerging nations on analytical quality issues in the Clinical Laboratory are addressed. Courses and materials were (and continuously are being) developed and provided to interested parties around the world. For example, Quality Assurance workshops were conducted in recent years in Croatia, Vietnam, Nepal, Tunisia and Sri Lanka. In addition, guidance documents and publications are being developed and provided via web sites and online courses.

Three current C-AQ projects are briefly discussed here:

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The Directory of EQA Services helps to meet External Quality Assurance (EQA) requirements Clinical Laboratories are regulatory required to establish and maintain External Quality Assurance (EQA) programs. It is often not trivial to find suitable organizing bodies helping in initiating specific programs for a given clinical laboratory, in particular in developing countries. To address this need, C-AQ recently developed a new data base and placed it on C-AQ’s web site for open access: the “Directory of EAQ Services.”

What is this Directory and how was it created?

C-AQ contacted all “IFCC countries” and other associated known bodies, via

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letter, asking for filling in the “blank” lines in the provided EXCEL sheet. Criteria were pre-assigned in columns. Examples are: “Country,” “Organizing Body,” “Name of EQA,” “Website Address,” “E-Mail Address,” and “Open to International.” Together with the indicated area of clinical application (like clinical chemistry, hematology, immunology, microbiology, molecular pathology, POCT, etc.), the returned information was collated into the present Directory available on the C-AQ web site (www.ifcc.org). This Directory/Data Base is accessible for all interested parties and can help in identifying the appropriate EQA program and organizing body in establishing this program in your laboratory.

This Directory is a “living document” and will be updated on a regular basis.

Teaching materials for Internal Quality Control (IQC) and External Quality Assurance (EQA) Two new documents, useful for teaching (and self-teaching) purposes were also placed recently on C-AQ’s website (see above link). These materials are self-explanatory and can serve a simple purpose: Understanding the need for internal and external quality requirements and their fulfilment in the clinical laboratory.

Besides these two documents, additional articles on quality-related questions are displayed and can be accessed on C-AQ’s website. This includes a “Minimum requirement list” to assist countries to plan and design an external quality assurance scheme, and the document “Procedure for Planning an EQA Scheme.”

Quality topics related “Resources Table” C-AQ currently works on a small data base which will group relevant publications under the three criteria: “Pre- and Post-analytical topics,” “Internal Quality Control,” and “External Quality Assessment.” These publications are current and include IFCC- (and other sourced) documents which offer guidance for many aspects of analytical quality-related questions. This work is underway and the “Resources Table” is expected to be ready soon for display on C-AQ’s IFCC website.

by Prof. Dr. Egon Amann, C-AQ Chair

NEWS

tory medicine as a value added resource. Our aims are to promote the understanding and the methodology of EBLM through educating laboratory professionals about finding, appraising and acting on the evidence.

Specifically, we seek to raise awareness of how to perform (and critique) primary diagnostic studies, how to carry out systematic reviews and how to make and implement evidencebased guideline recommendations in laboratory medicine. At the recent IFCC General Conference in Madrid, Hernan Fares-Taie, together with his young scientist son, Santiago presented all the media resources, including the Radio “El Microscopio” broadcasts with which they have successfully connected with large audiences in the

Latin American world. The challenge is how to extend this more globally.

We have traditionally supported workshops and visiting lecturers over many years, as well as many conference symposia. Given the increasing challenges of supporting face-to-face activities, however, we are currently canvassing international opinions on how to better approach the learning of EBLM. We have developed an IFCC curriculum for EBLM and are actively contributing modules to the IFCC eAcademy. This will include specific learning objectives, together with questions and eventually the opportunity to provide evidence of having completed the learning activities. We are aiming to promote self-guided learning with truly global access.

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EFLM CORNER

European Federation of Clinical Chemistry and Laboratory Medicine

Editor: Harjit Pal Bhattoa, MD, PhD, EuSpLM

Prof. Sverre Sandberg Elected New EFLM President

EFLM Executive Board 2016-2018

by Ana-Maria Simundic, EFLM EB Secretary rof. Sverre Sandberg (Norway) was elected as new President of the EFLM at the recent EFLM General Meeting held in Madrid on March 21, 2016. For the election of the position as EFLM Vice-President, the two candidates Prof. Michael Neumaier (Germany) and Prof.

Damien Gruson (Belgium, France) received the following votes: Prof. Michael Neumaier: 16 votes, Prof. Damien Gruson: 15 votes.

We are pleased to announce that the EFLM Executive Board is now composed as follows: President: Prof. Sverre Sandberg (Norway); Past-President: Prof.

Mauro Panteghini (Italy); Vice-President: Prof. Michael Neumaier (Germany); Secretary: Prof. Ana-Maria Simundic (Croatia); Treasurer: Dr. Huib Storm (The Netherlands); Member-at-Large: Prof. Grazyna Sypniewska (Poland); Member-at-Large: Prof. Tomas Zima (Czech Rep).

A debt of gratitude to the outgoing EFLM President, Prof. Mauro Panteghini, for his successful mandate and to the outgoing EFLM Past President, Prof. Ian Watson, who finished his term in the Executive Board.

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President: Sverre Sandberg

Secretary: Ana-Maria Simundic

Past-President: Mauro Panteghini

Treasurer: Huib Storm

Vice-President: Michael Neumaier

Member-at-Large: Grazyna Sypniewska

Member-at-Large: Tomas Zima

News from EFLM National Societies French Society of Clinical Biology (SFBC)

Norwegian Society of Medical Biochemistry (NSMB)

This is to inform you that SFBC has a new EFLM National Representative: Dr. Michel Vaubourdolle (Hôpitaux Universitaires Est Parisien, Paris) replacing Dr. Bernard Gouget. A warm welcome to Dr. Vaubourdolle as EFLM National Representative and a big thanks to Dr. Gouget for his always prompt involvement in all activities promoted by EFLM.

This is to inform you that NSMB has a new EFLM National Representative: Dr. Anne-Lise Bjørke Monsen (Haukeland University Hospital, Bergen) replacing Dr. Ann Helen Kristoffersen. A warm welcome to Dr. Bjørke Monsen and a big thanks to Dr. Kristoffersen for the involvement in EFLM activities in her 4 year term of office as EFLM National Representative.

EFLM Course: Developing Medical Tests That Improve Patient Outcomes November 9–11, 2016, Leiden, The Netherlands aboratory medicine has a poor record bringing new tests to market in a timely and effective way. Evidence based laboratory medicine (EBLM) provides the underlying principles for how a new biomarker should go through the test evaluation process but these principles alone do not appear to have guided better evaluation.

This course aims to address that gap by extending the principles of EBLM to provide some practical tools for the key processes of test evaluation.

Key Features of 21/2 day course: The course will be interactive and talks by keynote speakers will be followed by practical assignments.

Test evaluation – definitions and basic concepts Tools to conduct test evaluation including: Identifying unmet needs for biomarkers; Clinical pathway mapping to define the role and purpose of biomarkers in changing outcomes; Determination of analytical and clinical performance character-

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istics of biomarkers; Assessing the clinical effectiveness of biomarkers.

Talks to highlight the differing perspectives and experience of key stakeholders and experts in test evaluation Practical assignments to understand the use of test evaluation tools.

Target Audience: Qualified laboratory professionals; Researchers involved in biomarker development and test evaluation; Clinicians involved in biomarker use and evaluation in clinical practice; Healthcare company and regulatory representatives.

Secure your space at a Course delivered by the EFLM Test Evaluation Working Group.

Keynote Speakers: Rita Horvath, Patrick Bossuyt, Sverre Sandberg, Sally Lord, Phillip J Monaghan, and others. For further information, visit the course website at: www.eflm-testevaluation-course.eu. The participation is limited to 60 attendees – early registration within May 31.

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EFLM CORNER

European Federation of Clinical Chemistry and Laboratory Medicine

European Representation in the IFCC: A Historical Outline

In Memoriam: Prof. Gérard Siest

by Prof.Michael Neumaier, Vice-President EFLM (on behalf of the EFLM Executive Board)

by Ian D Watson, Chair of the EFLM History Task and Finish Group

ith great sadness we just had to learn that our dear colleague, fellow scientist and friend Prof. Dr. Gérard Siest has passed away.

Not only was Prof. Gérard Siest an untiring pacemaker of Clinical Chemistry and a restless protagonist to promote and sharpen the scientific profile of our profession.

For many years, his presence on scientific and general conferences was like an institution to us, and you could always be sure to find him around somewhere. Whether talking to colleagues in private conversation or participating in lively floor discussions, he was at his best when sharing his enthusiasm for new projects and his visions for the advancement of scientific Laboratory Medicine.

Gérard certainly had an impressive talent to get people interested in his ideas, and often - in good humor - he directly had a job from them.

During his brilliant professional career, Prof. Siest was always willing to take the baton to promote academic and scientific affairs. He served in the university Nancy both as dean of his faculty as well as vice president. He was president of IFCC (1991-196), and his presidential term is still regarded seminal for the strategic positioning of IFCC for the 21st century, particularly in bringing regional societies together.

Many of his activities have become “brands” like the Santorini conferences that he organized with Dr. Sophie Siest for so many years. We continue to be grateful for his excellent 12-year period as Editor-in-

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Photo: The first EFLM Executive Board (from left): M. Pazzagli, K. Pullki, R. Horvath, M. Hallworth, H. van Pelt, V. Blaton

The Beginnings, FESCC In the 1970’s a number of clinical chemists from a number of countries were concerned about the comparability of the profession in Europe.

From this initiative a Directive was developed. In 1987 at the World Congress in The Hague a meeting of the European Society Presidents was convened by Gerard Sanders, the NVKC President, from this a vocational training program was developed. It was clear that collaboration was beneficial and that a European regional organization had relevance and benefit; a Steering Committee under Prof.

Valdique was formed which consulted European societies in 1992. In 1993 FESCC (Forum of European Societies of Clinical Chemistry) was formed with Hermann Wisser as the first President and was recognized by IFCC with the support of the IFCC President Gérard Siest. FESCC focused its efforts on education, being particularly active in the Balkans.

Presidents: 1987-1990 – Hermann Wisser (Germany); 1991-1993 – Pierre Valdique (France); 1993-1996 – Josep Queralto (Spain); 1996-1999 – Vladimir Palicka (Czech Republic); 2000-2007 – Victor Blaton (Belgium).

EC4 While efforts to form FESCC reflected a desire for representation of the geographical continent of Europe, those societies whose nations were members of the European Economic Community recognized that there were particular issues, specifically the ease of movement between member countries; there was an informal meeting around 1977-1978 chaired by Ad Jansen [Netherlands] as there was a need for comparable competencies to be defined and communicated to decision makers; after a quiescent period EC4 (European Communities Confederation of Clinical Chemistry) was re-launched at EuroMedLab in

Nice in 1993. Along with developing a syllabus, the required training periods and attainments were identified, forming the basis for a voluntary register with the post-nominal of Eur Clin Chem the first certificates were awarded in 1998.

Presidents: 1996-1999 – Gerard Sanders (Netherlands); 1999-2005 – Rob Jansen (Netherlands); 20052007 – Mike Hallworth (UK).

Post-Merger – EFCC/EFLM With the expansion of the EU there was increasing commonality between FESCC and EC4 it was clear that a single organization would suffice; the FESCC and EC4 Presidents worked to form the European Federation of Clinical Chemistry and Laboratory Medicine (EFCC) at the 2007 EuroMedLab in Amsterdam; the acronym changed to EFLM when registered as a not-for-profit organization in 2013. The EC4 Register continued as an autonomous entity linked to EFLM. Presidents: 2007-2008 – Victor Blaton (Belgium); 2008-2009 – Mike Hallworth (UK); 2009-2011 – Andrea (Rita) Horvath (Hungary); 20112013 – Ian Watson (UK); 20132016 – Mauro Panteghini (Italy).

More Information: The EFLM History Task and Finish Group would value recollections from those who have been involved with EFLM’s predecessor organizations.

We would particularly value any documentation and photographs. Please contact me, Ian Watson at iandwat@ me.com or by phone: +447889324549.

An expanded version of this poster is available on the EFLM website: www.eflm.eu Acknowledgement: My thanks to past and present officers of FESCC, EC4, EFCC and EFLM for their recollections, documentation and photographs that have provided the background information.

Chief of CCLM that resulted in a steep incline in visibility and impact of one of our core scientific journal.

Similarly successfully, he did so for a number of other journals related to his prime research interests. Although long retired, he took to such time-consuming and strenuous tasks, because he clearly saw and emphasized the importance of strengthening publication organs capable to give laboratory sciences the appropriate forum and visibility.

His enthusiasm and efficiency in “getting the job done” was greatly appreciated as is reflected by the fact that he was elected board member in a number of scientific societies, where he served until now. It is therefore not surprising that he received numerous awards for his valuable contributions.

His last “pet project” was the foundation of the European Society for Pharmacogenomics and Personalized Therapy, a task he took on with his usual vigour. Within few years, he had built ESPT into a real success story and, as president of ESPT, continued to promote it together with many young and talented colleagues to a major platform for modern diagnostic science and health care.

On behalf of the European Society for Clinical Chemistry and Laboratory Medicine and all its members, the Executive Board of EFLM wants to express the sincerest condolences to Prof. Siest´s wife and our colleague Dr. Sophie Siest, his children and family for the tragic loss experienced.

4th Joint EFLM-UEMS Congress: Laboratory Medicine at the Clinical Interface Warsaw, 21-24 September 2016 he 4th Joint EFLM-UEMS Congress in Warsaw is the largest European event in Laboratory Medicine and Clinical Diagnostics in 2016. More than 50 international experts in the field of clinical medicine and laboratory diagnostics will present state of the art lectures and more than 700 participants, both laboratory professionals and clinicians, from all over the world are expected.

The Congress program includes scientific symposia, plenary lectures, poster sessions, debates, and educational workshops. Congress topics are selected to address hot topics of medicine, in areas such as cardiology, oncology, nephrology, neurology, endocrinology, transplantation, immunology, microbiology, paediatrics, among others. Laboratory diagnostics at the clinical interface spans from next generation sequencing, assessment of cell free DNA, mass spectrometry, to point-of-care-testing for diagnosing

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and predicting disease as well as for guiding and monitoring therapy.

The organizers particularly encourage young physicians, laboratory professionals, scientists, and researchers to submit their work. All abstracts will be reviewed by an international evaluation committee and the best abstracts will be selected as oral presentations. There are reduced registration fees for all young scientists <35 years and travel bursaries are available to participate in the Congress. Industry sponsored workshops will give the diagnostic industry the opportunity to present their latest innovations to a specialist audience.

Don’t miss this important event in the beautiful Warsaw. We look forward to seeing you in Warsaw this September!

Prof. Grazyna Sypniewska (EFLM, PTDL), President of the Congress and Organizing Committee Chair; Prof.

Eberhard Wieland (UEMS) Scientific Programme Committee Chair LabMedica International May/2016

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EFLM CORNER

Turkish Biochemical Society Marks 40th Anniversary he Turkish Biochemical Society (TBS) celebrated its 40th anniversary with a number of scientific and social activities during the 27th National Biochemistry Congress, which was held in the charming city of Antalya, during November 3–6, 2015.

The meeting was organized by TBS under the auspices of EFLM and IFCC, along with contributions from well-known IVD companies. More than 600 participants attended, and nearly 148 of them were students in their postgraduate education.

The opening ceremony started with the honorary speech of Nazmi Ozer (the former president) who gave a wonderful overview of the history of TBS with many photos from the past activities. After the ceremony of the honor awards given to colleagues who had served 40 years in the society, the opening talk was given by a celebrity, one of the most well-known stand-up artists (also a scriptwriter and a caricaturist), Gani Mujde. The participants welcomed this delightful and embracing talk, titled “God let our biochemistry match” that had many anecdotes from real life.

The scientific program of the Congress covered a large area of themes in laboratory medicine that were presented in 5 plenaries and 11 symposia. There was a wide range of interesting presentations from mass spectrometry and clinical laboratory to Vitamin D & Vitamin K2 relationship and bone metabolism markers, from food additives and their effects on toxicology and laboratory medicine, from noninvasive prenatal tests to innovations in the teaching of laboratory practices. All were delivered by wellknown speakers and experts and focused on quality assessment, standardization and method evaluation, performance criteria of laboratory tests, laboratory errors and patient safety. One of the most interesting plenaries was given by Asst. Prof. Dr. Mazhar Adli (Adli Lab, University of Virginia, School of Medicine, Dept. of Biochemistry & Molecular Genetics) about CRIPSR/Cas9 technology that is used for epigenome editing, chromatin structure manipulation, and imaging purposes.

As there are TBS members who are also very active in EFLM or IFCC working groups/ committees, the 27th National Biochemistry Congress included some unique sessions. Abdurrahman Coskun, TBS representative on EFLM and a member of the EFLM Working Group on Biological Variation (WG-BV), rationally questioned quality specifications in clinical laboratories and addressed to the hot topic of biological variation. TBS also has

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a very effective working group of Preanalytical Phase, led by Mehmet Senes. Their work was introduced in a session, and a very fruitful product of the group’s work, “Handbook of the guidelines for obtaining venous blood samples (phlebotomy)” was distributed to all participants of the Congress. “Guidelines on Clinical Laboratory Management of Chronic Kidney Disease,” written by Dogan Yucel, TBS President and a member of the IFCC Task Force for Chronic Kidney Disease (TF-CKD) was distributed to all participants of the Congress.

There were 263 posters submitted, out of which, 2 were selected every day by the Scientific Committee as the “Poster of the Day” and these were exhibited in a special area. There were 58 oral communications and majority of these were presented by young colleagues, as our association is very interested in motivating young laboratory professionals.

Laboratory medicine is in a permanent partnership with the clinical diagnostic industry and TBS specifically focuses on close relationship with our stakeholders, namely the IVD sector. During the Congress an exhibition of reagents, equipment, supplies, software, was organized by 31 diagnostic and research related companies some of which also gave valuable support for the attendance or accommodation of many young scientists to the Congress. Besides, TBS conducted a hallmark panel in collaboration with ARTED (Producers of Investigative Medical Technologies) on the future of IVD sector in Turkey, and this was followed by lively discussions.

There were five pre-congress workshops (scientific project writing, flow cytometry, optimization of the clinical laboratory, novel approaches in cancer research, mass spectrometry practice in clinical laboratory) and over 100 participants attended these.

All presentations and the abstracts of the congress were published in the special issue of Turkish Journal of Biochemistry (indexed in SCI Expanded, Journal Citation Reports/Science Edition, Chemical Abstracts, Directory of Open Access Journals, Index Copernicus, Embase, Scopus), a joint publication of de Gruyter and TBS. This Congress also included a very attractive and engaging social event; the Silent Auction. All senior colleagues who had contributed immensely to the advancement of biochemistry and laboratory medicine in the previous years donated some special objects (such as a book pub-

Photo: TBS Executive Board with former and honorary presidents

lished in the 1940’s, or a congress bag from the first congresses or a painting made by themselves, etc.) to this auction. All objects were displayed through the congress and offers were collected. On the gala dinner, the last offers were obtained for each object, and the bid was ended with the highest offer given. It was a very stimulating and delightful time for all participants. All the income from Silent Auction was put in a bursary fund in TBS to be used for young scientists in the coming years.

We are all very pleased with the scientific quality and the diversity of the presentations, the lively scientific interactions and networking as well as the appealing social program of the 27th National Biochemistry Congress. The success of this conference is a great motivation and challenge for the future of TBS. Last but not least, TBS is proud of its 40 years of history. Forty years of continuous and outstanding work brought a dual success in the development of the society. It is a dual success because TBS, with its members, not only contributed immensely

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to the improvement and advancement of clinical laboratory profession in Turkey but also in biochemistry and molecular life sciences, two areas that form the scaffold of all developments in laboratory medicine. The outcome is an active society with more than 2200 members and three branches in Istanbul, Izmir, and Adana. Besides being the member of IFCC since 1997, The Society has other international scientific affiliations with Federation of European Biochemical Societies (FEBS, 1978); International Union of Biochemistry and Molecular Biology (IUBMB, 1978); Balkan Clinical Laboratory Federation (BCLF, 1996); European Federation of Laboratory Medicine [EFLM (formerly FESCC, 1997]; Balkan Association of Biosciences (BAB, 1999); European Communities Confederation of Clinical Chemists (FESCC + EC4, 2007); World Association of Society of Pathologists and Laboratory Medicine (WASPaLM, 2013). We trust our next generation of young laboratory professionals who will carry the society even further in the coming years.

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2015 ANNUAL REPORT GENERAL ASSEMBLY EFLM held its Eighth General Meeting (GM) during the EuroMedLab in Paris (France) on Sunday, June 21, 2015. During the GM, EFLM President, Mauro Panteghini (MP), provided an overview of the recent EFLM activities since the last GM held in Liverpool. The importance of the EEFLM’s ongoing program supporting the presence of Executive Board (EB) members at NSs national congresses was emphasized as an excellent opportunity for EFLLM to strengthen its connections with EFLM NSs. MP briefly reported on the outcome of the 1st EFLM Strategic conference held in Milan, November 24–25, 2014, and the subsequent formation of the Task Force on Performance Specifications in L Laboratory Medicine and Task and related Finish Working Groups.

The role of young scientists in EFL LM was promoted by opening full member positions in EFLM working groups (WG) and granting bursaries to support their attendance at EFLM meetings. For instance, EFLM had received 76 applications for bursaries for the Euromedlab 2015 congress, out of which 10 best applicants were granted EFLM bursaries. MP also provided an overview of the progress of the 2014–2015 EFLM Strategic Plan. At the end of his presentation, MP thanked all EFL LM officers for their hard work.

Huib Storm (HS), EFLM Treasurer, gave a financial report.

Audit of the EFLM financial matters had been done in accordance with GAAP (General Accountant Audit principles). Two subsequent years were audited (2013 and 2014) by the certified auditor who checked whether the financial operations were in accordance with the existing legal rules and principles. The audit was successful and EFLM obtained a certificate proving that EFLM accounts were maintained fully in accordance with the Belgian law and GAAP. HS presented the balance sheets for 2013 and 2014 and explained each balance line. EFLM GM approved the balance sheet for 2013 and 2014 and the internal budget for 2014 and 2015.

During the GM elections were held and following EB members were elected: Mauro Panteghini re-elected as EFLM President Sverre Sandberg re-elected as EFLM Vice President Huib Storm elected for a second two-year term as EFLM Treasurer Ana-Maria Simundic elected for a second two-year term as EFLM Secretary Grazyna Sypniewska and Tomas Zima elected as Members-at-Large e The next GM will be held in Madrid in conjunction with the IFCC General Conference on March 21, 2016.

EXECUTIVE BOARD Through the EFLM program entitled EFLM Presence at NS meetings, during 2015 EB members participated in three EFLM NS meetings hosted by Bosnia and Herzegovina, Poland and Croatia.

EB has recently launched a call for nominations for the EFLM President and EFLM Vice President. Voting for these two EB positions shall take place in Madrid at the ninth GM. EFLM EB has discussed on several occasions the IFCC proposal on theselection of regional representatives in the IFCC EB. EFLM EB in principle believes that an individual representing a Region should be selected and participate in the policies and actions of a Region, and should be elected within that Region using the Region agreed electoral process.

This ensures a meaningful contextual representation of the Regional EB.

COMMITTEES Committee – Communication (C-C) A major effort of C-C during 2015 was dedicated to a rearrangement of the EFLM website, where a great care was devoted to improve the document retrieval in the EFLM publication list and to a better organization of the educational material. Following the publication of the EFLM corporate policy, an agreement has been reached with a number of IVD com-

panies to host in the EFLM web site their logo and some news. To improve the services for the Member Societies, the Table of Content of Clinical Chemistry and Laboratory Medicine (CCLM) is regularly sent through the EFLM mass mailing list that includes now more than 4,000 addresses. To increase the presence of EFLM within the professional community, a Linkedin group was created to promote discussions on relevant themes.

Committee – Education and Training (C-ET) EFLM has entitled C-ET to establish the EFLM continuing professional development (CPD) crediting system. To perform this task EFLM has decided to establish a specific Task and Finish group. C-ET has been involved in the organization of 15th EFLM Postgraduate Course, 11th Symposium of Balkan region and in selection of the venues of 5th EFLM-UEMS Congress and 22nd EuroMedLab. WG-Distance education (WG-DE) produced five e-seminars in 2015.

Committee – Profession (C-P) and EC4 Foundation Version 5 of the EC4 Syllabus for education and training of specialists in laboratory medicine across the EU community has reached its penultimate draft for circulation to EFLM EB and EC4 representatives early in 2016. Having accomplished this remit and the production of a Common Training Framework (CTF), the C-P WG on Syllabus/CTF was dissolved at the end of 2015.

WG on Recognition of professional qualifications continued its lobbying of the EU Commission for recognition of specialists in laboratory medicine under the EU Directive 2013/55/EU. EFLM and EC4 agreed to continue their subscriptions to CEPLIS (Council for the Liberal Professions in the EU) during 2016 as well as EU Commission lobbying activities on behalf of the profession. This second WG was also dissolved at the end of 2015, but its key leads have been invited to join an expanded C-P for 2016.

Concern was expressed at C-P and EC4 meetings in 2015 of the diminishing infrastructure around EC4 as more and more Europe-wide leadership for laboratory medicine transfers to EFLM. This was noted to be manifested through decreasing numbers of individuals seeking to join the EC4 Register as specialists in laboratory medicine and decreasing numbers of “hits” on an out-of-date EC4 web site. There is broad agreement that the leadership for achieving recognition of specialists through presentation of a CTF supported by 10 EU member states should now come from EFLM. C-P chair was requested to seek to dissolve the current EC4 Foundation and create an EFLM Foundation by end 2016 to which the necessary human, capital and organizational resources could be dedicated to achieve recognition of specialists in laboratory medicine through a register across the EU. Committee – Quality and Regulations (C-QR) C-QR performed a survey on the accreditation status in the different European countries. C-QR members published a paper on flexible scope approach for accreditation. At the end of 2015, C-QR was restructured by closing the WG-IVD and adding one WG-IVD member into the WG-A/ISO. Committee – Science (C-S) The nine WGs under this C (Biological Variation, Cardiac Markers, Guidelines, Harmonization of the Total Testing Process, Patient Focused Laboratory Medicine, Personalized Laboratory Medicine, Postanalytical Phase, Preanalytical Phase and Test Evaluation) and the three Task and Finish Groups (Laboratory Testing for Dyslipidemia, Critical Results and Standardization of the Color Coding for Blood Collection Closures) constitute the backbone and substance of the C-S. All groups have been active in pursuing their terms of reference, by performing studies, publishing original research reports, reviews and position papers. Members of the groups have also lectured at numerous international conferences and courses.

20–21, 2015, Porto (Portugal) 2. EFLM Symposium on Education in Clinical Chemistry and Laboratory Medicine, April 24–26, 2015, Prague (Czech Republic) 3. 11th EFLM Symposium for Balkan Region, May 14–15, 2015; Belgrade (Serbia) 4. EFLM Symposium Cutting Edge of Laboratory Management in Europe (CELME), October 1–2, 2015, Prague (Czech Republic) 5. 15th EFLM Continuous Postgraduate Course in Clinical Chemistry and Laboratory Medicine, October 24–25, 2015, Zagreb (Croatia)

PUBLICATIONS 1. Boursier G, et al; Working Group Accreditation and ISO/CEN standards (WG-A/ISO) of the EFLM. Accreditation process in European countries - an EFLM survey.

CCLM 2015, in press 2. Topic E, et al. How to assess the quality of your analytical method? CCLM 2015;53:1707-18.

3. Thelen MH, et al; Working Group Accreditation ISO/CEN standards (WG-A/ISO) of EFLM. Flexible scope for ISO 15189 accreditation: a guidance prepared by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO). CCLM 2015;53:1173-80.

4. Watson ID, et al; EFLM Working Group on Patient Focused Laboratory Medicine. European views on patients directly obtaining their laboratory test results. CCLM 2015;53:1961-6.

5. Ajzner É, et al; Joint Working Group on Postanalytical Phase (WG-POST) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and European Organization for External Quality Assurance Providers in Laboratory Medicine (EQALM). An international study of how laboratories handle and evaluate patient samples after detecting an unexpected APTT prolongation. CCLM 2015;53:1593-603.

6. Bartlett WA, et al; Biological Variation Working Group, European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). A checklist for critical appraisal of studies of biological variation. CCLM 2015;53:879-85.

7. Malentacchi F, et al; European Federation of Clinical Chemistry and Laboratory Medicine (EFLM); European Society of Pharmacogenomics and Personalized Therapy (ESPT) Joint Working Group on Personalized Laboratory Medicine (WG-PLM). Is laboratory medicine ready for the era of personalized medicine? A survey addressed to laboratory directors of hospitals/academic schools of medicine in Europe. CCLM 2015;53:981-8.

8. Simundic AM, et al. Compliance of blood sampling procedures with the CLSI H3-A6 guidelines: An observational study by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PRE). CCLM 2015;53:1321-31.

9. Lippi G, et al; European Federation for Clinical Chemistry and Laboratory Medicine Working Group for Preanalytical Phase. Preanalytical quality improvement. In pursuit of harmony, on behalf of European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working group for Preanalytical Phase (WG-PRE). CCLM 2015;53:357-70.

10. Mancini I, et al; European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)–European Society of Pharmacogenomics and Theranostics (ESPT) joint Working Group Personalized Laboratory Medicine (WG-PLM).

Implementation of a companion diagnostic in the clinical laboratory: the BRAF example in melanoma. Clin Chim Acta 2015;439:128-36.

11. Simundic AM, et al. Color coding for blood collection tube closures - a call for harmonization. CCLM 2015;53:371-6.

MEETINGS EFLM has organized five meetings during 2015: 1. 3rd EFLM-BD Conference on Preanalytical Phase, March

Special Supplement to Lab Medica International • 32

Mauro Panteghini, EFLM President

Prepared by Ana-Maria Simundic EFLM Executive Board Secretary February 12, 2016

Industry News

DiaSorin Acquires Molecular Diagnostics Concern in the US iaSorin (Saluggia, Italy; www. diasorin.com) and Quest Diagnostics (Madison, NJ, USA; www.questdiagnostics.com) have announced an agreement under which DiaSorin will buy the Focus Diagnostics (Cypress, CA, USA; www.focusdx. com) immunodiagnostic and molecular diagnostic products business.

As a result of the acquisition, DiaSorin will have access to Focus' product lines, including the Simplexa molecular line, the HerpeSelect HSV serology line, and the DxSelect immunofluorescence assay (IFA) and enzyme-linked immunosorbent assay (ELISA) assays. This will significantly increase its presence in the growing market of infectious disease molecular testing. DiaSorin will also strengthen its offering in the U.S. market by gaining access to approximately 200 hospitals served today by Focus.

Gaining access to the current Focus customer base in the United States, which consists mainly of large hospitals, will also allow DiaSorin to speed up U.S. market penetration of its LIAISON Immunoassay platform.

The company will also leverage its commercial presence worldwide to

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distribute Focus products in markets in Europe and Asia. Under the terms of the agreement, DiaSorin will pay to Quest Diagnostics USD 300 million in cash for all the tangible and intangible assets of Focus used to develop, manufacture, and distribute its molecular diagnostic products and its traditional immunoassay ELISA products.

"The combination of DiaSorin and Focus products will create a unique portfolio of specialty products, especially in the clinical area of infectious disease, which will continue to strengthen the leadership of DiaSorin in this segment," said Carlo Rosa, CEO of DiaSorin. "Also, this acquisition offers DiaSorin access to a large number of premier US hospitals that are served today by Focus, a market segment that is strategic for DiaSorin to grow in the future by combining the Focus molecular products with its broad LIAISON product line."

"As a leader in diagnostic products, DiaSorin is well positioned to build on the Focus platform of innovation to deliver continuing value to Focus' employees, customers and patients," said Steve Rusckowski, president and CEO of Quest Diagnostics.

In Vitro Diagnostics Market Projected for Swift Growth he global in vitro diagnostics (IVD) market is expected to expand rapidly owing to an aging population, chronic lifestyle related diseases, and increased usage of personalized medicine and point-ofcare (POC) testing. These are the latest findings of Grand View Research (San Francisco, CA, USA; www. grandviewresearch.com), a market research and consulting company.

Applications of IVD include oncology, cancer, nephrology, cardiology, drug testing, autoimmune diseases, diabetes and infectious diseases, with tests being used by a wide range of customers, including academic institutes, hospitals, and laboratories. Home testing is another application resulting from innovations and advancement in various IVD technologies, further enhancing the increasing role of POC disease diagnostics. This, along with the need for identification of malaria and filiarsis pathogens, are some of the key drivers of IVD market.

Increased consumer awareness of serious health issues such as diabetes, cancer, and sexually transmit-

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ted diseases are also rapidly altering the healthcare environment, creating a need for point-of-care (POC) recognition and detection of communicable diseases such as respiratory infections, respiratory syncytial virus (RSV), influenza, and pneumonia. Of particular interest is the tissue IVD market, which is expected to rise owing to the increasing incidents of lung and bronchus cancer, melanoma, and prostate breast cancer diagnosis.

Product-wise, the in IVD market is segmented into instruments, services, data management systems, reagents, and kits that are intended to diagnose, cure, prevent, or treat a particular disease. Different techniques are involved, including molecular diagnostics, blood tests, clinical chemistry, microbiological diagnostic techniques, and flow cytometry. The most commonly used technologies include electrolyte and metabolic panels; lipid and renal profiles; hematology, coagulation, and hemostasis microarrays; and radioimmunoassay and specialty chemicals, among others.

International Calendar For a free listing of your event, or a paid advertisement in this section, contact:

International Calendar, LabMedica International P.O.Box 802214, Miami, FL 33280-2214, USA Fax: 1-954-893-0038 • E-mail: info@globetech.net

JULY 2016 European Society for Human Reproduction and Embryology Annual Meeting – ESHRE 2016. Jul 3-6; Helsinki, Finland; Web: www.eshre.eu AACC 2016 – 67th Annual Meeting of American Association for Clinical Chemistry. Jul 31-Aug 4; Philadelphia, PA; Web: www.aacc.org

AUGUST 2016 FIME 2016 – Florida International Medical Exhibition. Aug 2-4; Miami, FL, USA; Web: www.fimeshow.com

SEPTEMBER 2016 34th International ISBT – International Society Blood Transfusion Congress. Sep 38; Dubai, UAE; Web: www.isbtweb.org Eurotox 2016 – 52nd Congress of the European Societies of Toxicology. Sep 4-7; Istanbul, Turkey; Web: www.eurotox2016.com 55th Annual ESPE Meeting – European Society of Paediatric Endocrinology. Sep 1012; Paris, France; Web: www.espe2016.org 19th Annual Meeting of the ESCV – European Congress of Virology. Sep 14-17; Lisbon, Portugal; Web: www.escv.org ASCP 2016 – American Society for Clinical Pathology. Sep 14-17; Mandalay Bay, Las Vegas; Web: www.ascp.org 26th International CPOCT Symposium.

Sep 21-24; Copenhagen, Denmark; Web: www.aacc.org 4th Joint EFLM-UEMS Congress Labora-

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Sep 21-24; Warsaw, Poland; Web: www. ifcc.org/ifcc-congresses-and-conferences 15th International Congress on Antiphospholipid Antibodies. Sep 21-24; Istanbul, Turkey; Web: www.isbtweb.org ESP 2016 – 28th European Congress of Pathology. Sep 25-30; Cologne, Germany; Web: www.esp-pathology.org 42nd Annual Meeting of the American Society for Histocompatibility and Immunogenetics (ASHI). Sep 26-30; St. Louis, MO, USA; Web: www.ashi-hla.org BSACI – British Society of Allergy & Clinical Immunology Annual Meeting. Sep 29Oct 1; Telford, UK; Web: www.bsaci.org

OCTOBER 2016 BCLF 2016 - 24th Meeting of Balkan Clinical Laboratory Federation. Oct 1-4; Tirana, Albania; Web: www.bclf.info 40th European Congress of Cytology. Oct 2-5; Liverpool, UK; Web: www.britishcytology. org.uk Analytica China. Oct 10-12; Shangai, China; Web: www.analyticachina.com/ ASHG 2015- The American Society of Human Genetics. Oct 18-22; Vancouver, Canada; Web: www.ashg.org

NOVEMBER 2016 Association for Molecular Pathology (AMP) Annual Meeting 2016. Nov 10-12; Charlotte, NC, USA; Web: www.amp.org MEDICA 2016. Nov 16-19; Dusseldorf, Ger-

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International Calendar many; Web: www.medica.de WASPaLM 2016- 29th World Congress of Pathology. Nov 18-21; Las Vegas, NV, USA; Web: www.waspalm.org 14th Asia-Pacific Federation for Clinical Biochemistry and Laboratory Medicine Congress. Nov 26-29; Web: www. apfcbcongress2016.org

JANUARY 2017 The British Fertility Society (BFS) Annual Meeting. Jan 5-7; Edinburgh, UK; Web: http://fertilityconference.org CBRD 2017 - 4th Caribbean Biomedical Research Days. Jan 16-18; Gros Islet, Saint Lucia; Web: www.stress-and-behavior.com

FEBRUARY 2017 SLAS 2017 - Society of Laboratory Automation and Screening. Feb 4-8; Washington, DC, USA; Web: www.slas.org Labquality Days2017. Feb 9-10; Helsinki, Finland; Web: www.labquality.fi

MARCH 2017 Pittcon Conference and Expo 2017. Mar 59; Atlanta, GA, USA; Web: http://pittcon.org KIMES 2017. Mar 16-19; Seoul, Korea; Web: www.kimes.kr ARABLAB 2017. Mar 20-23; Dubai, UAE; Web: www.arablab.com MEDLAB Asia Pacific 2017. Mar 29-31; Singapore; Web: www.medlabasia.com

APRIL 2017 ENDO 2017 – Endocrine Society Annual Meeting. Apr 1-4; Orlando, FL, USA; Web: www.endocrine.org MEDICAL FAIR INDIA. Apr 6-8; New Delhi, India; Web: http://medicalfair-india.com ECCMID 2017. Apr 22-25; Vienna, Austria; Web: www.eccmid.org/eccmid_2017

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MAY 2017 Biomarkers & Diagnostics World Congress 2017. May 2-4; Philadelphia, PA, USA; www.biomarkerworldcongress.com ISLH 2017 – International Society of Laboratory Hematology. May 4-6; Honolulu, HI, USA; Web: www.islh.org 19th European Congress of Endocrinology. May 20-23; Munich, Germany; Web: www.ese-hormones.org/meetings ESPID 2017- European Society for Paediatric Infectious Diseases. May 23-27; Madrid, Spain; Web: www.kenes.com/ espid_2017_lp ESHG 2017 - European Human Genetics Conference. May 27-30; Copenhagen, Denmark, Web: www.eshg.org

JUNE 2017 EuroMedLab 2017. June 11-15; Athens, Greece; Web: www.ifcc.org FOCIS 2017 - Federation of Clinical Immunology Societies. June 14-17; Boston, MA, USA; Web: www.focisnet.org 2017 BIO International Convention. June 19-22; San Diego, CA, USA; Web: http:// convention.bio.org

JULY 2017 FEMS 2017- 7th Cong. of European Microbiologists. July 9-13; Valencia, Spain; Web: www.fems-microbiology2017.kenes.com AACC 2017 – 68th Annual Meeting of American Association for Clinical Chemistry. July 30-Aug 3; San Diego, CA, USA; www.aacc.org

SEPTEMBER 2017 ESP 2017 - 29th European Congress of Pathology. Sep 2-6; Amsterdam, Netherlands; www.esp-congress.org

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