LabMedica International March 2016

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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. 1 • 2-3/ 2016

DAILY CLINICAL LAB NEWS

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Gene Test Validated for Breast Cancer Therapy genetic test has been clinically validated in predicting which patients with early-stage breast cancer are unlikely to benefit from chemotherapy.

Many women with hormone receptor-positive breast cancers also undergo chemotherapy in order to destroy any cancer cells that many have

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Breakthrough Technology Characterizes Immune Response ssays enabling the identification and enumeration of antigen-specific T cells are critical tools in characterizing immune responses and harnessing T cell function for treatment of numerous diseases including cancer.

A novel multiplex assay has been developed that combines convention-

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al immune monitoring techniques and immune receptor repertoire sequencing to enable identification of T cells specific to large numbers of antigens simultaneously.

Scientists at Adaptive Biotechnologies (South San Francisco, CA, USA; www.adaptivebiotech.com) multiplexed 30 different antigens and

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Image: Courtesy of Luke Lee / University of California Berkeley

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Liquid Biopsy Tests Offer Game-Changer In Cancer Treatment

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Quick Test Minimizes Unnecessary Antibiotic Prescriptions

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-reactive protein (CRP) is a biomarker in blood, which indicates the presence of inflammation, and the amount of CRP in the body gives an indication of the severity of an infection.

Low levels of CRP are indicative of viral Cont’d on page 4

Early Warning Biomarker for Chronic Kidney Disease

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simple blood test for a specific protein can predict a person’s chances of developing chronic kidney disease five years before symptoms emerge, thus doing for kidney disease what cholesterol has done for cardiovascular disease.

Relatively high plasma levels of the specific protein soluble urokinase-type

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he ability to simultaneously detect and identify multiple biomarkers is one of the key requirements for molecular diagnostic tests that are becoming even more important as personalized and precision medicine place increased emphasis on such capabilities. Integrated optofluidic platforms can help create such highly sensitive, multiplexed assays on a small, dedicated chip and a method for multiplex fluorescence

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he diagnosis of celiac disease requires a tissue sample from the small intestine, which can be extremely unpleasant, but a blood test has been developed which provides a rapid, painless answer.

The tissue samples are taken by gastroscopy, which means a tube being inserted down the throat to the duodenum and then tissue samples must also be taken in order to obtain a definite diagnosis. This can be very

Image: A lung cancer tumor cell in situ

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On-Chip Optical Sensing Of Multiple Flu Strains

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Simplified Blood Test For Celiac Disease

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ersonalized cancer treatment requires the frequent tracing of cancer DNA in the blood, in order to determine and monitor the treatment most likely to work for the individual patient. Emerging liquid biopsy tests are now offering a noninvasive, simpler and more-effective alternative to surgical biopsies toward that end.

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plasminogen activator receptor (suPAR) have been associated with focal segmental glomerulosclerosis and poor clinical outcomes in patients with various conditions. Scientists at Rush University Medical Center (Chicago, IL, USA; www.rush.edu) and a large team of collaborators, measured plasma suPAR Cont’d on page 6

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Liquid Biopsy Tests Offer Game-Changer in Cancer Treatment he biotech company Roche, an acknowledged leader in research-focused healthcare with combined strengths in pharmaceutical and diagnostic innovation, is focusing on the development of new tools for personalized lung cancer diagnostics and treatment.

Personalized treatment demands genomic characterization of the patient’s tumor cells and DNA testing requires sampling of the tumor, either from surgical or liquid biopsy specimens. However, critically ill lung cancer patients may not be able to undergo a surgical biopsy and may not have enough accessible tumor tissue.

Liquid biopsy is a simple and noninvasive alternative to surgical biopsy in which traces of the cancer’s DNA in the blood can give clues about which treatments are most likely to work for that patient.

Genomic instability resulting in copy number variation is characteristic of malignant transformation and may be identified through next-generation massive parallel sequencing. Tumor-specific cell free DNA (cfDNA) is released by dying cancer cells into the serum and plasma where it provides a real-time, easily accessible target for this approach. Analysis of this type of liquid biopsy specimen is straightforward and not invasive so it can be easily repeated in order to monitor changes in the genetics of each lung cancer patient’s individual tumor.

Cancer cell genomics testing may be carried out with new generation assays such as the recently CEmarked Roche EGFR Mutation Test v2 for non-smallcell lung cancer (NSCLC), which allows clinicians to replace surgical biopsy specimens with readily accessible blood samples that contain tumor-specific cfDNA. The EGFR Mutation Test v2 is the first oncology assay from Roche (Basel, Switzerland; www.roche.com) that utilizes either plasma or tumor tissue as a sample.

The test identifies 42 mutations in the epidermal growth factor receptor (EGFR) gene, the most of any in vitro diagnostic (IVD) test on the market, and can also be used as an aid in selecting eligible patients with non-

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or self-limiting bacterial infections, and high levels indicate serious infection. Almost 80% of antibiotics are prescribed in primary care and respiratory tract infections (RTIs) are the reason for 60% of these antibiotic prescriptions. The vast majority of these infections are self-limiting or caused by viruses in which case antibiotics have little or no clinical benefit for patients. C-reactive protein point of care testing (CRP POCT) has successfully helped to identify patients who did not require antibiotics, when presenting with symptoms of RTIs. A study that was recently conducted that included 99 patients, aged 5 to 75 years who visited their general practitioner (GP) with a chesty cough. After undergoing a clinical scoring system, each patient’s CRP levels were measured at the point of care using the Afinion CRP test, a rapid in vitro diagnostic assay for quantitative determination of CRP (Alere; Waltham, MA, USA; www.alere.com). Only 13% of these patients needed antibiotic treatment as the CRP POCT had concluded higher CRP levels. Within one month, 17% of the 99 patients returned to the surgery and only 5% were prescribed antibiotics.

The study also provides insights on patients’ expectations of receiving antibiotics. All participants had to complete a questionnaire in which they were asked

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labmedica.com EDITORIAL BOARD Graham Beastall United Kingdom Claus Christiansen Denmark Hernán Fares Taie Argentina Bernard Gouget France Jocelyn M. Hicks United States Anders Kallner Sweden Tahir S. Pillay South Africa Christopher Price United Kingdom Andreas Rothstein Colombia Dmitry B. Saprygin Russia Rosa I. Sierra-Amor Mexico Gérard Siest France Peter Wilding United States Andrew Wootton United Kingdom

small-cell lung cancer (NSCLC) for therapy with an EGFR tyrosine kinase inhibitor (TKI). Additionally, Roche has developed a cfDNA sample preparation kit that is optimized for extracting the DNA from plasma.

The EGFR Mutation Test v2 was designed to run on the cobas 4800 System, v2.1 or higher. The system can also be used for the detection of mutations in the KRAS and BRAF gene of tumor samples.

“Liquid biopsies could be a game-changer in cancer testing,” said Miro Venturi, global head diagnostics biomarkers at Roche. “In terms of patient acceptability and disease management, the benefits of noninvasive, quick and easily repeatable tests are clear. And in the longer term, liquid biopsies may ultimately be used to catch signs of cancer early, before symptoms arise. This could make a significant difference to the way we understand and treat cancer.”

A small number of liquid biopsy tests have already been approved and are available in some countries, and many more are in development. This new approach to cancer diagnostics is expected to revolutionize cancer detection and treatment.

Other types of diagnostic tests are also in development that can investigate tumor tissue or circulating tumor cells for multiple biomarkers at the same time or to determine whether there are multiple genetic defects present in the same tumor cell.

Quick Test Minimizes Unnecessary Antibiotic Prescriptions cont’d from cover

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whether they expected to receive antibiotics for their symptoms. Of the 26 patients expecting to receive antibiotics, only seven (27%) patients received them. Additionally, patients with lower CRP levels, who therefore would not have been suitable for antibiotics, were more likely to expect an antibiotic when asked.

CRP POCT takes less than five minutes from a finger stick blood sample to provide a quantitative result and helps to facilitate an effective conversation between patients and GPs around the rational use of antibiotics. The CRP POCT is already used in routine management in several European countries to aid diagnosis in suspected RTI and guide decision making regarding antibiotic prescribing.

Rob Cook, MD, who was involved in the study and a GP from London, said, “This study was conducted to see how feasible and useful CRP POCT is in real world general practice. We found that the test could be easily incorporated into routine care and provided very useful information for GPs and patients presenting with a cough. The vast majority of patients were reassured by a low CRP level and did not receive antibiotics.” The study was presented at the Royal College of General Practitioners (RCGP) Annual Conference held October 1-3, 2015, in Glasgow (UK; www.rcgp.org.uk).

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ISSN 1068-1760 Vol.33 No.1. Published, under license, by Globetech Media LLC; Copyright © 2016. All rights reserved. Reproduction in any form is forbidden without express permission. Opinions expressed are solely those of the authors, and do not represent an endorsement, or lack thereof, by the Publisher of any products or services.

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Breakthrough Technology Characterizes Immune Response cont’d from cover

identified 427 antigen-specific clonotypes from five individuals with frequencies as low as one per million T cells. The clonotypes identified were validated several ways including repeatability, concordance with published clonotypes, and high correlation with Enzyme-Linked ImmunoSpot (ELISPOT).

Antigen-specific T cells were identified using one of two approaches: either by dextramer binding or by CD137 upregulation following overnight incubation with mixtures of peptides. Dextramer-specific T cells were identified by incubating peripheral blood mononuclear cells (PBMCs) with pools of eight dextramers. The new assay was named MIRA for Multiplexed Identification of T cell Receptor Antigen specificity.

The ELISPOT results for four antigens were independently generated for each donor. ELISPOT measures the total number of antigen-specific T

cells secreting a particular cytokine. If all antigenspecific T cells secrete the cytokine measured by ELISPOT then results would be analogous to the sum frequency of antigen-specific clonotypes identified by MIRA. The scientists compared IFNELISPOT results with the sum frequency of antigen-specific clonotypes from each donor. There was a high correlation between results from both assays and MIRA readily detected antigen-specific clonotypes below 1 in 100,000 PBMCs, below estimates of the limit of detection for ELISPOT of around 4 spots per 100,000 PBMCs. Harlan Robins, PhD, Chief Scientific Officer and Co-Founder at Adaptive Biotechnologies, said, “With this new multiplex technology we now have the ability to assign antigen-specificity to T cell receptors (TCR) sequences at a massive scale.

Combined with our first-in-class technology for pairing TCR alpha and beta chain sequences at

high throughput, we now have the tools needed for efficient identification of functional immune receptors, which may lead to tremendous advancements in biomarker discovery and therapeutic development.” The study was published on October 28, 2015, in the journal Public Library of Science ONE. Image: A colored scanning electron micrograph (SEM) of T-lymphocytes (pink) that recognize antigens on a tumor cell (yellow) through T-cell receptors (Photo courtesy of Steve Gschmeissner / SPL).

Early Warning Biomarker For Chronic Kidney Disease cont’d from cover

levels in 3,683 persons enrolled in the Emory Cardiovascular Biobank and determined renal function at enrollment. Their mean age was 63 years; 65% were men; and the median suPAR level, 3,040 pg/mL and at subsequent visits in 2,292 persons. The relationship between suPAR levels and the estimated glomerular filtration rate (eGFR) at baseline, the change in the eGFR over time, and the development of chronic kidney disease (eGFR <60 mL per minute per 1.73 m2 of body-surface area) were analyzed.

Serum concentrations of high-sensitivity C-reactive protein (CRP) were determined with the use of a particle-enhanced immunoturbidimetry assay (FirstMark; GenWay Biotech, San Diego, CA, USA; www.thefirstmark.com) that has a lower limit of detection of 0.03 mg/L. Plasma levels of suPAR were measured with the suPARnostic kit (ViroGates; Birkerød, Denmark; www.virogates.com), which has a lower limit of detection of 100 pg/mL. The intra-assay variation is 2.75% and the interassay variation is 9.17%.

Of the 2,292 enrollees, 40% of subjects with high suPAR levels, greater than 3,040 ng/mL but no known kidney disease as indicated by, healthy eGFR levels, went on to develop chronic kidney disease over the course of five years. In comparison, only 10% of those with low suPAR levels at baseline developed the disease. Moreover, suPAR was shown to predict eGFR decline in patients with already established earlier stage kidney disease as well. From a cohort of patients with cardiovascular disease, the study divides suPAR levels into four quartiles: normal suPAR: less than 2,373 pg/mL; above normal: 2,373–3,030 pg/mL, high: 3,040–4,020 pg/mL, and very high: above 4,020 pg/mL. The study was published on November 5, 2015, in the New England Journal of Medicine.

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Molecular Diagnostics Platform and Dedicated HSV Assay Set to Debut latest-generation molecular diagnostics platform has already been cleared for use by the [US] Food and Drug Administration (FDA).

The Luminex Corporation (Austin, TX, USA; www.luminexcorp.com) has announced that the receipt of FDA clearance for the company’s new ARIES System and its dedicated ARIES HSV (herpes simplex virus) 1&2 Assay.

The herpes simplex virus 1 (HSV1) causes a lifelong, contagious infection, which is common and endemic throughout the world. It is mainly transmitted through oral-oral contact and causes “cold sores.” There is no cure, although treatment can reduce symptoms. HSV-2 infection, which causes genital herpes that is characterized by the occasional appearance of painful genital ulcers, is widespread and mainly sexually transmitted. It is estimated that up to 20 million people are newly infected with HSV-2 each year.

The ARIES system utilizes the Luminex proprietary MultiCode realtime polymerase chain reaction (PCR), and multiplex PCR-based technologies. MultiCode products, which are used for the early detection of infectious diseases and genetic-based conditions, are centered on the unique MultiCode bases, isoC and isoG. The synthetic isoC:isoG

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DNA base pair differs from the naturally occurring base pair in its hydrogen bonding pattern. As a result, the MultiCode bases, isoC and isoG, can only base pair with each other. This property enables site-specific incorporation of the isobases during amplification. The isoC and isoG MultiCode bases form the building blocks for Luminex’s next generation MultiCode assays for nucleic acid-based testing.

The ARIES instrument uses internal barcode scanning and other advanced features to minimize operator errors. Two independent modules each support from one to six cassettes, allowing for both STAT and batch testing. An integrated touch screen PC eliminates the need for a separate computer, stand-alone keyboard, and mouse; thus maximizing valuable bench space.

“We are pleased to have received a rapid clearance from the FDA for our game-changing ARIES System and ARIES HSV 1 & 2 Assay as it represents a significant milestone for Luminex and a turning point for the molecular diagnostic industry,” said Homi Shamir, president and CEO of Luminex. “There has never been more pressure on clinical laboratories to increase efficiency while improving the overall quality of patient care through the delivery of

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accurate and timely data. To solve this challenge, Luminex designed the ARIES sample to answer testing platform to streamline the workflow and raise the performance bar for all laboratory professionals no matter how big or small the setting. To increase ARIES’ utilization and drive rapid top-line revenue growth a key priority will be to rapidly expand our test menu to cover the full range of disease modules. We believe that the launch of ARIES will

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increase our potential market to cover 6,500 hospital labs, a 13-fold increase over our current available customer base in the USA.” Luminex introduced the ARIES products at the November 4-7, 2015, Association for Molecular Pathology (AMP) annual meeting in Austin (TX, USA).

Image: The ARIES molecular diagnostics platform (Photo courtesy of Luminex).

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On-Chip Optical Sensing Of Multiple Flu Strains cont’d from cover

detection of single bioparticles by creating color-dependent excitation spot patterns from a single integrated waveguide structure has been developed.

Biophysicists at the University of California, Santa Cruz (CA, USA; www.ucsc.edu) have described a novel method to perform diagnostic assays for multiple strains of influenza virus on a small, dedicated chip. They demonstrated a novel application of a principle called wavelength division multiplexing, which is widely used in fiber-optic communications. By superimposing multiple wavelengths of light in an optical waveguide on a chip, they were able to create wavelength-dependent spot patterns in an intersecting fluidic channel. Virus particles labeled with fluorescent markers give distinctive signals as they pass through the fluidic channel depending on which wavelength of light the markers absorb.

The team tested the device using three different influenza subtypes labeled with different fluorescent markers. Initially, each strain of the virus was labeled with a single dye color, and three wavelengths of light were used to detect them in a mixed sample. In a second test, one strain was labeled with a combination of the colors used to label the other two strains.

Again, the detector could distinguish among the viruses based on the distinctive signals from each combination of markers. This combinatorial approach is important because it increases the number of different targets that can be detected with a given number of wavelengths of light. For these tests, each viral subtype was separately labeled with fluorescent dye. For an actual diagnostic assay, fluorescently labeled antibodies could be used to selectively attach distinctive fluorescent markers to different strains of the influenza virus.

Holger Schmidt, PhD, a professor of Optoelectronics and lead author of the study, said, “A standard flu test checks for about ten different flu strains, so it’s important to have an assay that can look at 10 to 15 things at once. We showed a completely new way to do that on an optofluidic chip. Each color of light produces a different spot pattern in the channel, so if the virus particle is labeled to respond to blue light, for example, it will light up nine times as it goes through the channel, if it’s labeled for red it lights up seven times, and so on.” The study was published on October 6, 2015, in the journal Proceedings of the National Academy of Sciences of the United States of America (PNAS).

Image: A schematic view shows the optical waveguide intersecting a fluidic microchannel containing target particles.

Targets are optically excited as they flow past well-defined excitation spots created by multimode interference; fluorescence is collected by the liquid-core waveguide channel and routed into solid-core waveguides (red) (Photo courtesy of University of California, Santa Cruz).

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Diabetic Risk in Obesity Delineated by Metabolic Status he simple anthropometric measure of body mass index does not always reflect the biological effects of excessive body fat on health, thus additional molecular characterizations of obese phenotypes are needed to assess the risk of developing subsequent metabolic conditions at an individual level. A panel of markers has been discovered that helps identify if a person is pre-diabetic by measuring the fatty acids in their blood and this discovery may allow physicians to warn their patients years before the onset of diabetes, therefore allowing them to change their lifestyle patterns potentially avoiding the diagnosis of a chronic disease.

Scientists at the University of Hawaii Cancer Center (Honolulu, HI, USA; www.uhcancercenter.org) working with colleagues in China carried out four independent studies that included 312 subjects in the cohort, 132 healthy subjects were normal weight, 107 subjects were either overweight or obese, and 73

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subjects had been diagnosed with type 2 diabetes (T2D) complicated with hypertension, high cholesterol or hypertriglyceridemia. They also selected 62 subjects who were overweight/obese and metabolically healthy at baseline, of which, 50 became unhealthy overweight/obese and 12 remained healthy overweight/obese after ten years. Another cohort was from a metabolic surgery intervention study of 40 obese patients with T2D and 53 obese metabolically healthy volunteers.

Serum samples from the four studies were processed and analyzed using the same protocol. The samples were analyzed using Ultra Performance Liquid Chromatography coupled to a hybrid quadrupole orthogonal time of flight mass spectrometer (UPLCQTOF-MS), (Waters Corporation; Milford, MA, USA; www.waters.com). In the cross-sectional study, comprising 132 normal-weight (NW), 107 healthy overweight/obese subjects (HO), and 73 overweight/

obese subjects diagnosed with T2D, the team observed that there were significant differences among the three groups according to body mass index (BMI) and key metabolic markers.

Weiping Jia, PhD, a professor and senior author of the study said, “Currently there are no clinical tests that tell you the likelihood of developing diabetes, only exams that tell you for example if someone that is pre-diabetic has relatively high blood sugar or insulin levels. To know if you are likely to get diabetes in a few years is an important discovery. People can hopefully get tested for the disease during physical exams in the future.” The study was published on October 6, 2015, in the journal EbioMedicine.

FDA Approves First of Its Kind Companion Dx for Lung Cancer Patients he US Food and Drug Administration (FDA) have approved the first complementary diagnostic test to support use of OPDIVO (nivolumab) for non-squamous non-small-cell lung cancer (NSCLC) therapy.

Historically, the one-year overall survival in the second-line treatment of NSCLC has been about 26%. The new test, “PD-L1 IHC 28-8 pharmDx” from Dako Denmark A/S (Glostrup, Denmark; www.dako.com), an Agilent Technologies company, is a qualitative immunohistochemical (IHC) assay that can identify PD-L1 expression levels on the surface of NSCLC tumor cells and provide information on the survival benefit of therapy with OPDIVO for patients with non-squamous NSCLC. Dako developed the diagnostic through collaboration with Bristol-Myers Squibb, maker of OPDIVO, an immuno-oncology therapy FDA-approved for treatment of patients with previously treated NSCLC. Dako’s test was used to assess PD-L1 expression in the Phase-3 CheckMate 057 trial, in which OPDIVO demonstrated superior overall survival in patients with previously treated metastatic non-squamous NSCLC compared to chemotherapy. The FDA on October 9, 2015, expanded the indication for OPDIVO to include previously treated non-squamous NSCLC in addition to the squamous NSCLC indication. PD-L1 IHC 28-8 pharmDx is the first and only diagnostic assay FDA-approved to assess survival benefit associated with OPDIVO. PD-L1 testing is not required for use of OPDIVO, but it may provide additional information for physicians and inform patient dialogue.

“We are excited about Agilent’s involvement in these advancements and the potential PD-L1 IHC 288 pharmDx has in helping to provide information to oncologists considering OPDIVO for patients with non-squamous NSCLC,” said Jacob Thaysen, president, Diagnostics and Genomics Group, Agilent.

“We are proud to announce the recent FDA approval of OPDIVO based upon overall survival in an expanded indication for all appropriate patients with previously treated metastatic NSCLC,” added Michael Giordano, senior vice president and head of Development, Oncology, Bristol-Myers Squibb, “Our collaboration with Dako underscores our leadership in cancer innovation and our commitment to advancing research evaluating the potential role of PD-L1 in multiple tumor types.”

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Handheld Nanopore DNA Sequencer Rapidly Detects Viral Infections in Blood Samples handheld nanopore DNA sequencer was used to accurately identify and differentiate viruses in patient blood samples with an unprecedented sample-to-answer turnaround time of less than six hours.

The Oxford Nanopore Technologies (Oxford, United Kingdom; https://nanoporetech.com) MinION nanopore sequencer rapidly determines the sequence of subject DNA through the application of protein nanopore technology. The method is based on a protein channel – only a few nanometers in diameter – through which a single strand of DNA can pass. As the DNA strand passes through the nanopore, it generates a series of characteristic electrical signatures, from which nucleotide bases can be identified, and the sequence of the strand determined. The instrument is powered and operated by a laptop computer via a USB connection.

Investigators at the University of California, San Francisco (USA; www.ucsf.edu) used a MinION instrument to analyze blood samples from four patients for Chikungunya virus (CHIKV), Ebolavirus (EBOV), and Hepatitis C virus (HCV).

They reported that at high titers ranging from 107 to 108 copies per milliliter, reads to EBOV from two patients with acute hemorrhagic fever and CHIKV from an asymptomatic blood donor were detected within 4 to 10 minutes of data acquisition, while lower titer HCV virus (1x105 copies per milliliter) was detected within 40 minutes. Confirmation of results was obtained by sequencing with an Illumina Inc. (San Diego, CA, USA; www.illumina.com) MiSeq instrument.

Nanopore sequencing is a third-generation sequencing technology that has two key advantages over second-generation technologies – longer reads and the ability to perform real-time sequence analysis.

As of mid-2015, the MinION nanopore sequencer was capable of producing at least 100,000 sequences with an average read length of five kilobases, in total producing up to one gigabase of sequence in 24 hours on one flow cell.

In the current study, the investigators presented nanopore sequencing for metagenomic detection of viral pathogens from clinical samples with a sample-to-answer turnaround time of less than six hours. They also introduced MetaPORE, a real-time web-based sequence analysis and visualization tool for pathogen identification from nanopore data.

“To our knowledge, this is the first time that nanopore sequencing has been used for real-time metagenomic detection of pathogens in complex clinical samples in the setting of human infections,” said senior author Dr. Charles Y Chiu, associate professor of laboratory medicine at the

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University of California, San Francisco. “Unbiased point-of-care testing for pathogens by rapid metagenomic sequencing has the potential to radically transform infectious disease diagnosis in both clinical and public health settings. This point-of-care genomic technology will be particularly attractive in the developing world, where critical resources, including reliable electric power, laboratory space, and computational server capacity, are often severely limited. The study was published in the September 29, 2015, online edition of the journal Genome Medicine.

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Image: A close-up of the MinION nanopore sequencer (Photo courtesy of Dr. Andrew Kilianski, Edgewood Chemical Biological Center).

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Simplified Blood Test For Celiac Disease cont’d from cover

unpleasant, and children are put under anesthetic during this type of examination. Scientists from the Faculty of Medicine at the University of Oslo (Norway; www.med.uio.no) have now developed a new blood test that makes it much simpler to diagnose celiac disease. The test uses a reagent composed of human leukocyte antigen (HLA) molecules and fractions of gluten, which are added to the blood sample. A reagent is a substance to which something is added to detect the presence of another substance.

In this case the reagent binds itself to the T cells that are in the blood sample. Magnetized antibodies are

also added which in turn bind to the reagent.

Asbjorn Christophersen, PhD, a Postdoctoral fellow, said, “When the food that one eats enters the small intestine, it is reduced to tiny fractions and presented to the T cells on so-called HLA molecules. The HLA molecules present various elements of what one consumes, as well as what is inside the cells. The task of the T cells is to monitor cells to see if they are infected by viruses or bacteria. In the case of celiac disease, the T cells think that gluten is a virus or bacteria. The T cells send a message to the other immune cells to attack not only the gluten protein itself, but also cells, and an enzyme

that binds itself to gluten and thus the small intestine becomes inflamed.”

Dr. Christophersen added, “When we allow blood cells to flow through a magnetic column, the cells that react to gluten remain suspended in the column while all the other cells flow through it. We observe that celiac patients have a much higher number of gluten-reactive T cells in their blood than non-celiacs. The level is more or less independent of how much gluten they eat. We are now in contact with several leading international companies that are interested in using the technique for the diagnosis of celiac disease.”

Gene Test Validated for Breast Cancer Therapy cont’d from cover

spread beyond the breast and reduce the risk of recurrence. While some of these women may not need chemotherapy, there is currently no effective way of determining which women could safely avoid the treatment.

A large team of scientists led by those at the Montefiore Medical Center (Bronx, NY, USA; www. montefiore.org) used a 21-gene expression assay on 10,273 women ages 18 to 75 who had early-stage, hormone receptor-positive breast can-

cer, whereby the cancer is driven by estrogen or progesterone and that did not overexpress human epidermal growth factor receptor (HER2).

Prospective validation was performed with the use of archival tumor specimens from completed studies that used a prospective–retrospective design.

All the patients had an Oncotype DX Recurrence Score (Genomic Health, Redwood City, CA, USA; www.oncotypedx.com), a reversetranscriptase–polymerase-chain-reac-

tion 21-gene assay performed on ribonucleic acid (RNA) extracted from formalin-fixed paraffin-embedded tissue, performed in a central laboratory. Patients with a score of 0 to 10 were assigned to receive endocrine therapy alone, and those with a score of 26 or higher were assigned to receive chemotherapy plus endocrine therapy.

A total of 1,626 of whom were eligible, which was 15.9% of the total eligible population had a recurrence score of 0 to 10 (indicating low risk), 6,897 of whom were eligible which was 67.3% of the total eligible population had a score of 11 to 25 (indicating midrange risk), and 1,730 of whom were eligible being16.9% of the total eligible population, had a score of 26 or higher (indicating high risk). The median follow-up in the low-risk cohort was 69 months. The team found that around 99% of lowrisk women treated with hormone therapy alone did not experience

breast cancer recurrence within five years. Furthermore, the rate of invasive disease-free survival at five years was almost 94%, while the risk of cancer returning at a distant site was less than 1%.

The authors concluded that their prospective study involving uniformly treated patients with hormone-receptor-positive, HER2-negative, axillary node-negative breast cancer supports the clinical validity of the 21gene assay in identifying patients who may be safely spared adjuvant chemotherapy. Joseph A. Sparano, MD, the lead authors of the study, said, “The compelling results seen in this global study provide unequivocal evidence supporting the clinical utility of Oncotype DX to risk-stratify patients with early-stage breast cancer, and indicate that the findings are generalizable to everyday clinical practice.” The study was published on September 28, 2015, in the New England Journal of Medicine.

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Arterial Blood Liquid Biopsy Detects Circulating Melanoma Cells enous blood collection is simple and minimally invasive, and this approach has made circulating tumor cells (CTC) testing readily available to many cancer patients. The major drawback is the fact that CTCs are not always detectable for patients with clinically evident metastatic disease.

Currently, assays for CTCs have been approved for diagnostic purposes in metastatic breast, colorectal, or prostate cancer. In these diseases, the presence of CTCs in the peripheral blood is associated with decreased progression-free survival and decreased overall survival. The major challenge for this technology is that CTCs are not always found in the blood of patients with aggressive disease who would be expected to have high numbers.

Scientists at Thomas Jefferson University (Philadelphia, PA, USA; www.jefferson.edu) obtained blood specimens from both common femoral arteries and antecubital veins in 17 uveal melanoma patients with multiple hepatic metastases for CTC measurements. All patients had their primary uveal melanoma treated between 2000 and 2013. Ten patients had received radioactive plaque as their treatment for primary uveal melanoma and seven patients had enucleation of their affected eye. None of these patients had a local recurrence of primary uveal melanoma at the time of CTC measurement.

CTCs were analyzed using the standard

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CellSearch protocol and CellTracks Circulating Melanoma Cell Kit on the CellSearch System (Janssen Diagnostics, LLC, Raritan, NJ, USA; www. janssendiagnostics.com). Cells expressing CD146 (Mel-CAM) were immunomagnetically enriched and stained with phycoerythrin (PE)-conjugated antibody specific to high molecular weight melanoma associated antigen (HMW-MAA), which is specific for melanoma cells. Samples were scanned on the CellTracks analyzer II fluorescent microscope (Veridex, LLC; Raritan, NJ, USA; www.cellsearchctc.com).

The investigators compared blood samples taken from uveal melanoma patients’ veins compared to that collected from arteries, and found a much higher number of circulating tumor cells in blood collected from the arteries than in the veins. CTCs were detectable with greater frequency (100%) and in larger numbers (median 5, range 1 to 168) in all arterial blood specimens than in venous samples (52.9%; median 1, range 0 to 8). Patients with hepatic as well as extra-hepatic metastasis showed higher number of arterial CTCs, compared to patients with liver-only metastasis.

The authors concluded that their data indicated

that arterial blood, rather than venous blood, might be suitable for future investigation on CTCs in uveal melanoma patients. This would also raise the concern as to whether venous blood specimens are a suitable source for investigation on CTCs in other types of cancer. Although it is more technically difficult to collect blood from an artery than a vein, this study suggests that checking arterial blood may be a more accurate way of assessing circulating tumor number, and therefore metastatic disease. The study was published on September 18, 2015, in the journal EBioMedicine.

Image: The CELLSEARCH semi-automatic system that can capture and quantify circulating tumor cells (Photo courtesy of Janssen Diagnostics).

5-Gene Panel Confirmed for High-Risk Pediatric Rhabdomyosarcoma aper confirmed the usefulness of a five-gene panel for identifying children with a high-risk form of the muscle cancer rhabdomyosarcoma (RMS). RMS has two common histological subtypes: embryonal (ERMS) and alveolar (ARMS). PAX–FOXO1 fusion gene status has been shown to be a more reliable prognostic marker than alveolar histology, whereas fusion gene–negative (FN) ARMS patients are clinically similar to ERMS patients. Children with FN-RMS usually present with a more aggressive form of the disease.

A five-gene expression signature (MG5) was shown previously to identify two diverse risk groups within the population of FN-RMS patients, but this had not been independently validated.

In the current study, investigators at The Institute of Cancer Research (London, United Kingdom; www. irc.ac.uk) used a NanoString Technologies (Seattle, WA, USA; www. nanostring.com) nCounter analysis system to profile MG5 gene expression in samples taken from 68 patients from the Children’s Oncology Group’s (Monrovia, CA, USA; www.

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childrensoncologygroup.org) D9803 study of children with intermediaterisk RMS. Results revealed that the MG5 signature score showed a significant correlation with overall and failure-free survival. The MG5 test sorted fusionnegative patients into two distinct groups, based on the activity of the five genes. Patients with high scores had significantly worse survival chances than those with low scores, suggesting the test could ultimately be included in assessment of children with RMS. “Our research showed a significant link between a particular gene signature from tumor samples and higherrisk, aggressive rhabdomyosarcoma.

This study is an important step towards introducing an approach that identifies children who are unlikely to benefit from current, standard treatments and can be offered more intensive or new treatment strategies that will improve their outcome,” said contributing author Dr. Janet Shipley, professor of cancer molecular pathology at The Institute of Cancer Research.

The paper was published in the October 15, 2015, online edition of the journal Clinical Cancer Research.

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Prognostic Index IdentifiesRisk of Testicular Cancer Relapse he assessment of just three features can identify those at most at risk of relapse of a common kind of testicular cancer known as non-seminomatous germ cell tumor (NSGCT) even where there is no evidence of tumor spread.

Predicting who does or does not need chemotherapy is important in order to minimize treatment, with its undesirable side effects and a new test could be used in clinics to make decisions about which patients should be given chemotherapy. Patients diagnosed with testicular cancer in the early stages face a choice between monitoring with treatment, if relapse occurs, and moving directly on to chemotherapy with its associated long-term side effects.

Scientists at The Institute of Cancer Research (Sutton, UK; www.icr.ac.uk) analyzed 177 tumor samples from patients with stage 1 non-semino-

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matous tumors, enrolled in clinical trials through the Medical Research Council (MRC) Clinical Trials Unit. Specifically these were patients diagnosed with stage I NSGCT (negative tumor markers and computer tomography scan confirming stage I) and enrolled post-operatively into a randomized study of two alternate imaging surveillance protocols.

Complete tumor cases were retrieved from each patient, and a full set of hematoxylin and eosin (H&E) sections from tumor for each case were examined by a board certified histopathologist. Sections were deparaffinized prior to immunochemical staining for C-X-C motif chemokine 12 (CXCL12) (R&D Systems; Minneapolis MN, USA; www. rndsystems.com). Antibodies were visualized using the Bond Polymer Refine Kit (Leica Biosystems; Newcastle, UK; www.leicabiosystems.com).

Immunostaining was performed on the Leica Bond-Max automated immunostainer. To investigate CXCL12 as a marker for relapse prior to application to the clinical trial sample sets, the team first studied the tissue microarrays (TMA) representing 59 cases.

The tests were validated in an additional group of 80 patients. The vast majority of patients were in the low-risk group: 94.3% did not relapse in two years. In the moderate-risk group, 65.9% did not relapse. Strikingly, only 30% of patients did not relapse in the highrisk group. The authors concluded that CXCL12 and percentage embryonal carcinoma both stratify patients’ relapse risk over and above vascular invasion alone. This is anticipated to improve the stratification of patients and identify high-risk cases to be considered. The study was published on October 3, 2015, in the journal Clinical Cancer Research.

Elevated Levels of Small Nucleolar RNA Predict More Aggressive Colorectal Cancer igh levels of the small nucleolar RNA SNORA42 in patients with colorectal cancer (CRC) have been shown to indicate that the patient may have a tumor that is especially aggressive, resistant to treatment, and prone to migrate and metastasize.

Small nucleolar RNA SNORA42 is a non-coding RNA (ncRNA) molecule that functions in the modification of other small nuclear RNAs (snRNAs). This type of modifying RNA, called a snoRNA, is usually located in the nucleolus of the eukaryotic cell, which is a major site of snRNA biogenesis. SNORA42 belongs to the C/D box class of snoRNAs, which contain the conserved sequence motifs known as the C box (UGAUGA) and the D box (CUGA). Most of the members of the box C/D family function in directing site-specific 2’-O-methylation of substrate RNAs. As recent evidence had revealed a new role

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for snoRNAs in oncogenesis, investigators at Baylor University Medical Center (Dallas, TX, USA; www.baylorhealth.edu) systematically evaluated dysregulation of snoRNAs in CRC and clarified their biomarker potential and biological significance in CRC. Results revealed that SNORA42 was overexpressed in colorectal cancer cells, compared with normal tissue, and its expression significantly correlated with disease progression. Overexpression resulted in the cancer cells’ ability to multiply rapidly, form tumors, migrate, invade normal tissue, and survive apoptosis. When SNORA42 was experimentally suppressed, these effects were reversed. Elevated expression appeared to be a predictor for recurrence and poor prognosis in patients with colorectal cancer.

The paper was published in the October 15, 2015, online edition of the journal Gut.

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Meridian’s Malaria Assay Takes Detection and Prevention to New Levels

By Karen Appold Interviewees: Ken Kozak, Chief Technical Officer, Meridian Bioscience, Inc.; Prof. Daouda Ndiaye, Department of Parasitology-Mycology, Cheikh Anta Diop University of Dakar, Senegal LabMedica: Why was a better test for malaria needed?

Kozak: Current testing methodologies are not sensitive enough to detect all active malaria cases, especially those who are carriers of the disease with low levels of parasitaemia.

LabMedica: How does illumigene® Malaria differ from other malaria tests?

Kozak: illumigene® Malaria, which leverages the power of loop-mediated isothermal amplification (LAMP), is orders of magnitude more sensitive in detecting the malaria parasite (Plasmodium spp.) than rapid diagnostic tests (RDTs) and microscopy. Given this, along with the fact that illumigene Malaria employs a simple procedure using stabilized reagents, it has the potential to revolutionize malaria diagnosis and establish the new gold standard.

Meridian Bioscience offers two different molecular-based assays that can detect very low levels of parasites. Depending on the species, illumigene Malaria can detect 2 - 0.25 parasites per microliter (µL) from human venous whole blood samples, while illumigene Malaria Plus identifies 0.2 - 0.063 parasites per µL. Other Nucleic Acid Amplification based assay systems that can detect one or two parasites per microliter require extraneous equipment such as heat blocks, centrifuges for sample purification, and expensive thermocycling instrumentation. Since illumigene Malaria only requires a power source to run, it is designed to be run outside of a traditional clinical laboratory. It can perform 10 assays at a time, and its reader/incubator has a small 8½-by-11 inch footprint.

Photo: UCAD staff and collaborators; HARVARD, CDC Atlanta, USAID, BROAD, NIH, TULANE, MRC, UBM, UG, Meridian Bioscience

LabMedica: How was illumigene Malaria tested?

Who was involved in developing the clinical trials?

Kozak: The Centers for Disease Control and Prevention (CDC) initially challenged illumigene’s DNA amplification assay with a series of blinded samples, in which it performed well. Given this, the CDC offered us technical assistance and recommended clinical trial sites. We selected a laboratory in Senegal, Africa, managed by Prof.

Ndiaye – a Harvard PhD world expert physician in malaria diagnosis. He worked with our protocols and generated the necessary data to demonstrate the assay’s strong utility.

The blinded study compared microscopy, RDT, and PCR methods to our assays. The CDC performed the PCR assays and also provided us with enumerated parasites, which showed that illumigene’s assays’ limits met The World Health Organization’s standards and recommendations.

LabMedica: How much better is your malaria test vs. the gold standard (microscopy)? How many more patients was your test able to detect during clinical studies?

Kozak: The illumigene Malaria can detect infected individuals that are out of the reach of other tests.

The average microscopy (the current Gold Standard) laboratory test can detect 50 to 100 parasites per µL. The microscopy experts at the Senegal lab could detect 20 parasites per µL. Even when compared to a laboratory with strong microscopy expertise, illumigene Malaria still detected about 10% more positives than microscopy.

This was in an area with high prevalence. This number could significantly increase if used in lower prevalence regions at labs that do not have the experience in tropical medicine.

Photo: Ken Kozak and Prof. Douda Ndiaye, at Meridian Bioscience Malaria launch meeting in Paris, France.

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LabMedica: What are the main barriers to diagnosing malaria effectively, and how does illumigene overcome them?

Prof. Ndiaye: Malaria is most prevalent in subSaharan Africa, where medical centers are typically overcrowded and under equipped. Laboratory technicians are often unskilled in diagnosing the mosquito-borne infectious disease, with false-positives as high as 75% of cases in preelimination settings due to submicroscopic parasitemia and 40% of inexperienced healthcare practitioners making incorrect diagnoses using microscopy. Diagnostic tools require several year’s training in microscopy and regular refresh training, which demand substantial financial support. illumigene technology is simple, accurate, and easy to use; specialist technical expertise is not required. The test is stable at room temperature.

LabMedica: Discuss the importance of a quick and accurate diagnosis.

Prof. Ndiaye: Malaria is one of the top three killers of children worldwide, claiming one life every minute. In just two hours, malaria can progress from a mild case to a life-threatening one. Some patients die within 24 hours. illumigene results are available in less than 50 minutes. Earlier diagnosis enables the correct treatment to be prescribed, which leads to better clinical outcomes for someone with malaria and keeps malaria treatments for the right people.

LabMedica: What other disease areas is illumigene involved in?

Kozak: illumigene tests using LAMP technology are already used to diagnose infectious diseases including Clostridium difficile, whooping cough, and the Herpes Simplex Virus, where they have proved highly accurate. Malaria is the tenth assay available on the illumigene platform, which is used in nearly 1,500 institutions worldwide.

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Biomarkers Predict HIV Return When Treatment Stopped reatment of Human Immunodeficiency virus 1 (HIV-1) infection with antiretroviral therapy (ART) in the weeks following transmission may induce a state of “post-treatment control” (PTC) in some patients, in whom viremia remains undetectable when ART is stopped.

Primary HIV-1 infection (PHI), the period within weeks to months of seroconversion, may provide insights into how this reservoir is activated and whether it can be suppressed, as stopping ART initiated in this early stage has in certain patients been associated with periods of aviremic remission, in some cases for over 10 year.

Scientists at the John Radcliffe Hospital (Oxford, UK; www.ouh.nhs.uk) and their collaborators retrospectively analyzed data from a randomized study of patients with primary HIV infection involved in the SPARTAC trial. They compared the Tcells of 154 patients in Europe, Brazil and Australia who had their ART treatment interrupted after 12 or 48 weeks. T-cells play a central role in protecting the immune system. They devised a panel of 18 biomarkers to measure parameters of host immunity and markers of the HIV-1 reservoir.

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The investigators used a variety of methods including the measurement of HIV-1 DNA, the quantitation of unspliced cell-associated HIV-1 RNA Transcript which was performed on the Lightcycler 480 (Roche; Basel, Switzerland; www.roche.com), quantification of the HIV-1-specific CD8 response was performed by IFN- ELISpot analysis (R&D Systems; Minneapolis, MN, USA; www.rndsystems.com), fluorescent activated cell sorting run on a MAQSquant flow cytometer (Miltenyi Biotec; San Diego, CA, USA; www. miltenyibiotec.com). Interleukin-6 (IL-6) and D-dimer were quantified using commercial assays.

The scientists found that high levels of the T-cell exhaustion markers programmed cell death protein 1 (PD-1), T-cell immunoglobulin domain and mucin domain-3 (Tim-3) and Lymphocyte-activation gene 3 (Lag-3) measured prior to ART strongly predict time to the return of viremia. The data suggests that the size of the reservoir is determined

by T-cell-mediated immunity in early HIV-1 infection, reflected in the number of associations between HIV-1 DNA and immune biomarkers at baseline. Once ART is commenced and viral replication is suppressed, the CD4 T-cell count recovers

and the HIV-1 reservoir declines.

The authors concluded that participants undergoing treatment interruption after 48 weeks of ART reveals potential new biomarkers that should be considered in larger studies exploring PTC. The correlations between measures of T-cell-mediated immunity and HIV-1 DNA prior to therapy make a case for the reservoir size being determined by Tcell function early in infection. T-cell exhaustion markers may identify those latently infected cells with a higher proclivity to viral transcription. The study was published on October 9, 2015, in the journal Nature Communications.

Image: The Miltenyi MACSQuant flow cytometer analyzer (Photo courtesy of The McGowan Institute).

Commercial Kits Evaluated for Rapid Diagnosis of Tuberculosis he tuberculosis (TB) interferon-gamma release assay (IGRA) detects the release of interferon-gamma (IFN-γ) in fresh heparinized whole blood samples from test subjects.

In IGRA assays, the blood samples are incubated with mixtures of the two specific Mycobacterium antigens present in Mycobacterium tuberculosis: early secretory antigenic target 6 (ESAT-6) and culture filtrate protein 10 (CFP-10). Scientists at the Chinese Center for Disease Control and Prevention (Beijing, China; www.chinacdc.cn) enrolled a total of 1,026 participants at three hospitals, including 597 tuberculosis (TB) patients diagnosed clinically

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(517 patients with pulmonary TB and 80 patients with extrapulmonary TB) and 429 negative controls (244 patients with pulmonary disease but not TB, or with non-tuberculosis mycobacterial lung diseases), and 185 healthy people. Detection performance indicators including sensitivity, specificity, and the Youden index (YI) were used to evaluate performance of commercial IGRA kits.

Blood specimens and sputum samples were tested and analyzed with bacteriological assays (including sputum smear and bacterial culture) and the three commercial cellular immune detection kits: TB.IGRA (Beijing Wantai Biopharm Co., Ltd.; Beijing, China;

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www.ystwt.cn), QB.SPOT (Kinghawk Pharmaceutical Co., Ltd.; Beijing, China; www.kinghawk828. om), and T-SPOT.TB (Oxford Immunotec; Oxford, UK; www.oxfordimmunotec.com) simultaneously.

Sputum samples from the pulmonary TB patients were subjected to smear acid-fast staining, followed

by Mycobacterium culture on Löwenstein–Jensen medium. Among 597 clinically diagnosed TB patients, the sensitivity of T-SPOT.TB, QB-SPOT, and TB-IGRA was 78.2%, 78.9%, and 74.9%, respectively, with no significant difference in sensitivity among the three kits. For the 80 extrapulmonary TB cases, the sensitivity of T-SPOT.TB, QB-SPOT, and TB-IGRA was 66.3%, 70.0%, and 68.8%, respectively, with no significant difference in sensitivity among the three kits. For the 517 PTB patients, the sensitivity of T-SPOT.TB, QB-SPOT, and TBIGRA was 81.1%, 80.3%, and 75.8%, respectively.

This was compared to 24.7% (125/507) for smear staining and 45.0% (219/487) for bacterial culture.

There was a significant difference in sensitivity between the bacterial methods and the three kits.

There was a significant difference in sensitivity of TSPOT.TB and QB-SPOT between PTB and extrapulmonary TB patients, but not for TB-IGRA. The authors concluded that the data obtained in the current study suggest that the three commercial kits have comparable detection performance in PTB when the bacteriological method is used as the “gold standard.” These kits will also be a very useful aid in the clinical detection and diagnosis of M. tuberculosis infection, especially in patients with smear-negative and culture-negative and extrapulmonary TB. The kits will be beneficial for TB control in China and elsewhere. The study was published online on September 7, 2015 in the International Journal of Infectious Diseases.

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PRODUCT NEWS URINE CCM TUBE

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FLOCKED SWABS

CONTROL FORMULATION

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The VACUETTE urine CCM tube stabilizes the bacterial count in urine to allow for microbiological testing. The high solubility of the powder stabilizer enables the sample to remain within a constant temperature of 20–25 °C for up to 48 hours, and a safety cap offers hygienic working conditions.

The PurFlock Ultra and HydraFlock flocked swabs use multi-length fibers to create a web-like structure that collects and retains more specimen than traditional swabs. They are the most efficient swabs available for collecting, absorbing and releasing viable cells in lab research and diagnosis.

The new formulation for Dip&Spin urinalysis dipstick/microscopics control features improved crystal sediment component with Calcium Oxalate Dihydrate (COD) in their native octahedral morphology. They are easily identifiable via standard light microscopy and automated microscopy methods.

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Pancreatic Cancer Tumor and Stroma Subtypes Discovered sing a novel approach in the largest gene expression analysis to-date of pancreatic cancer (PC), researchers have identified subtypes of PC tumors and of surrounding stroma tissue, potentially paving the way for more personalized therapeutics.

Dense surrounding stroma tissue can block drugs from reaching PC tumors, but can also help prevent the cancer from spreading. A new multi-institutional collaborative study, led by researchers of the Lineberger Comprehensive Cancer Center, University of North Carolina (UNC) School of Medicine (Chapel Hill, NC, USA; www.med.unc.edu) sheds light on the conflicting role of the stroma by revealing subtypes of PC stroma and tumors based on molecular characteristics.

“We still treat PCs as one entity, while for some other cancers we personalize treatment based on an individual patient’s tumor genetics or other characteristics,” said senior author Jen Jen

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Yeh, MD, associate professor and vice chair for research, Surgery Dept., UNC School of Medicine, “We believe these results will set the groundwork for future clinical trials, allow treatments to be assigned based on the subtypes, and guide the development of new therapies.”

The study provides the most rigorously validated classification system for pancreatic ductal adenocarcinoma to-date. Previous studies that identified PC subtypes were likely confounded by the large amount of surrounding stroma intermixed with both normal and cancerous pancreatic tissue. To solve this problem, the team, led by Richard Moffitt, PhD, postdoctoral research associate at UNC Lineberger, used a mathematicsbased approach called blind-source-separation.

“PC is a particularly difficult cancer to analyze because of its confounding stroma, so we needed to marry the right data analysis technique to the right problem,” said Dr. Moffitt.

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The approach allowed the researchers to separate normal from cancerous and stroma tissues.

They were then able to examine gene expression patterns for each type in tissue samples from five different institutions: analyzing 145 primary and 61 metastatic tumors, 17 cell lines, as well as 46 normal pancreatic samples and 88 samples of normal, non-cancerous tissue outside of the pancreas.

They discovered 2 subtypes of pancreatic stroma, which they named “normal” and “activated.”

Patients with the activated subtype had worse survival outcomes. “This study helps make sense of researchers’ conflicting findings about stroma—that it can either promote or be a barrier to tumor spread,” said Prof. Yeh, “We are seeing 2 distinct types of stroma in patients.”

Their analysis also revealed 2 subtypes of PC tumors. The subtype they called “basal-like” is linked to worse outcomes for patients: only 44% of patients with basal-like subtype lived 1 year after surgery, compared to 70% survival for patients with the other subtype, called “classical.”

Basal-like tumors trended toward a better response to adjuvant therapy. “If we know that your tumor is aggressive, then it may be important to treat your whole body first with neo-adjuvant therapy, which is therapy given prior to surgery, as opposed to just trying to remove the tumor with surgery at the outset,” said Prof. Yeh, “In addition, the basal-like subtype is very similar to basal breast and bladder cancers, which respond to therapies differently than other tumor subtypes, so we are very interested in seeing whether or not this is true for PC as well.”

The findings suggest that treatment decisions should be based on both a patient’s stroma and tumor subtype. Clinical trials will investigate how patients with the different subtypes respond to treatment. “For pancreatic cancer in particular, it’s a race against the clock,” said Prof. Yeh, “you don’t have a lot of time to try different therapies.”

The study, by Moffitt RA et al, was published online September 7, 2015, in the journal Nature Genetics.

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PRODUCT NEWS LAB BIOMARKER

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Increased D-Dimer levels occur during fibrinolytic processes, indicating thrombus degradation. DDimer offers a reliable biomarker for exclusion of thrombotic events. The ready-to-use assay with high precision and diagnostic sensitivity ensures reliable negative prediction of thrombotic events.

The Agility system offers a fully automated platform for true ELISA optimization. State-of-the-art robotic processing delivers unparalleled precision, eliminating nearly all manual steps. Key features include an intelligent design, an intuitive, easy-touse interface, and continuous sample loading.

The ELITe InGenius sample-to-result system consolidates complex MDx needs in one easy-to-use and flexible solution. It features a sample-to-result solution with comprehensive test menu for quantitative/qualitative monitoring of pathogens following solid organ/stem cell transplantation.

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Ebolavirus Found in Semen Months After Symptom Onset he main mode of transmission is direct contact with the blood or body fluids of a person with Ebolavirus disease (EVD) or from the body of a person who died from EVD; however, Ebolavirus can persist in the body fluids of survivors during convalescence, which may result in transmission of the virus.

Previously, survivors of EVD were told to practice sexual abstinence or to use a condom for three months after recovery. These recommendations were based on virus-isolation results from semen specimens obtained from eight survivors of EVD or Marburgvirus disease in previous epidemics in which the longest period that infectious virus was found in semen after the onset of symptoms was 82 days.

A large international team of scientist led by those from the Sierra Leone Ministry of Health (Freetown, Sierra Leone; www.health.gov.sl) recruited a convenience sample of 100 male survivors from the Western Area District of Sierra Leone, which includes the capital of Freetown.

They identified study participants who, at informational events that were held in conjunction with survivor associations, indicated interest in participation, as well as persons who were referred from Ebola treatment centers. A member of the study team administered a questionnaire to all the participants at the time of enrollment to gather information about their EVD episode, self-reported health status, sexual behavior, and sociodemographic characteristics, and the date of EVD onset was selfreported.

Semen specimens were collected and refrigerated at 5 °C to 8 °C for no longer than three days and transported to the field laboratory. The team performed quantitative reverse transcription polymerase chain reaction (RT-PCR) testing using Ebolavirus–specific gene targets (NP and VP40) and the human 2-microglobulin (B2M) gene. A specimen was considered positive if the VP40 and NP gene targets were both detected within 40 cycles of replication. The specimen was considered to be neg-

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ative if neither Ebolavirus gene targets were detected nor the findings with respect to B2M status were positive. The findings were ruled to be indeterminate if either the VP40 or the NP gene target was detected but not both. Amplification of B2M served as an extraction control and RNA quality control.

A total of 46 of the 93 men (49%) had a specimen that was positive on quantitative RT-PCR. Ebolavirus RNA was detected in the semen of all 9 men from whom a specimen was obtained during the first three months after the onset of illness, in the semen of 26 of 40 men (65%) from whom a specimen was obtained at four to six months, and in the semen of 11 of 43 men (26%) from whom a specimen was obtained at seven to nine months.

The longest time after the onset of a participant’s EVD symptoms that a semen specimen obtained at baseline remained positive on quantitative RT-PCR was 284 days. Indeterminate results were encountered in 10 initial specimens in the range of 152 to 273 days after the onset of symptoms.

The study was published on October 14, 2015, in the New England Journal of Medicine.

Image: A colorized transmission electron micrograph (TEM) revealed some of the ultrastructural morphology displayed by an Ebolavirus virion with supplemented spermatozoa (Photo courtesy of Frederick A. Murphy/CDC, and Graphic by Mark Murrman).

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Blood Types Correlate with Survival After Prostate Cancer Vaccine imple, inexpensive strategies to target treatment to likely responders could substantially improve efficacy while simultaneously reducing health care costs, but identification of reliable biomarkers has proven challenging.

ABO blood type influences numerous aspects of biology and medicine, such as susceptibility to infection by various pathogens and potential for complications due to blood transfusions and while there are a variety of methods for typing patients, standard methods are not ideal for all situations.

Chemical biologists at the National Cancer Institute, National Institutes of Health (Frederick, MD, USA; http:// ncifrederick.cancer.gov) and their colleagues obtained 220 sera samples consisting of 93 type O individuals, 58 type A individuals, 32 type B individuals, and 37 type AB individuals. All samples were stored at -80 °C or -20 °C until used.

Blood type information was available in the clinical records for eight patients with metastatic castration-resistant prostate cancer (mCRPC) who enrolled in a singlecenter phase II study of a prostate vaccine.

Blood typing methods were developed using the normalized antibody signals to Blood Group A (BG-A) and BG-B antigens.

For two component systems, the BG-A and BG-B components were systematically varied to identify optimal pairings. For each component, the signal ranges were partitioned into three groups: positive, negative, and unclassified. The team developed a new glycan microarray-based method for determining ABO blood type.

The method requires only 4 L of serum, provides 97% accuracy, and allows simultaneous profiling of many other serum anti-glycan antibodies. After validation with 220 healthy subjects of known blood type, the method was then applied to 74 PROSTVAC-VF patients and 37 control patients from a phase II trial.

The authors concluded that that type B and O prostate vaccine trial patients demonstrated markedly improved clinical outcomes relative to A and AB patients, including longer median survival, longer

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Image: Prostate cancer cells. A vaccine has been developed to help prevent the recurrence of prostate cancer (Photo courtesy of Wellcome Images).

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median survival relative to Halabi predicted survival, and improved overall survival via Kaplan-Meier survival analysis. Consequently, blood type may provide an inexpensive screen to preselect patients likely to benefit from prostate vaccine therapy.

The study was published on August 18, 2015, in the journal Oncotarget.

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Non-Hodgkin Lymphoma Linked to Q Fever Bacterium he incidence of non-Hodgkin lymphoma (NHL), associated with significant mortality, is increasing in many regions, making it a global health challenge for the coming years.

The bacterium Coxiella burnetii causes Q fever, which is an infectious disease that is primarily transmitted through the excrement of cattle, sheep, and goats and humans contract it from these animals is associated with an increased risk of lymphoma.

A large team of French scientists led by those at the Aix-Marseille University (Marseille, France; www. univ-amu.fr) screened 1,468 patients treated at the French National Referral

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Center for Q fever from 2004 to 2014.

Acute Q fever was defined by the association of clinical symptoms (fever, hepatitis and/or pneumonia) with the serological criteria of a phase II immunoglobulin G (IgG) titer equal to or greater than 200 and a phase II IgM titer equal to or greater than 50, seroconversion or a positive polymerase chain reaction (PCR) and no endocarditis.

Formalin-fixed and paraffin-embedded biopsy samples were analyzed by an expert hematopathologist in all cases to confirm the diagnosis of lymphoma. Immunofluorescence (IF), 16S ribosomal ribonucleic acid (rRNA) fluorescence in situ hybridization

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(FISH) and genomic DNA FISH were performed as well as other diagnostic techniques. The amount of interleukin-10 (IL-10) in sera was determined using specific immunoassays (R&D Systems; Minneapolis, MN, USA; www.rndsystems.com). IL10 and Tumor necrosis factors (TNF) were measured in supernatants from non-stimulated and C. burnetii stimulated peripheral blood mononuclear cells (PBMC).

The team found, based on their analysis, that patients with Q fever were 25 times more likely to develop diffuse large B-cell lymphoma than those without the infection. In addition, the odds of lymphoma in patients with persistent concentrated infections are higher than those with other forms of Q fever. The investigators observed that Q fever patients with lymphoma demonstrated overproduction of the critical anti-inflammatory pathway IL-10, suggesting

that suppression of the immune system may have allowed the lymphoma cells to evade immune detection and multiply.

Didier Raoult, MD, PhD, the senior author of the study, said, “As we continue to learn more about the association between C. burnetii and lymphoma, these results should encourage clinicians to survey high-risk patients as early as possible for potential cancer. Ultimately, this early diagnosis and treatment would improve outcomes for Q fever patients who subsequently develop lymphoma, particularly those with B-cell nonHodgkin lymphoma.” The study was published on October 13, 2015, in the journal Blood.

Image: A dry fracture of a Vero cell exposing the contents of a vacuole where Coxiella burnetii, the causative agent of Q fever, are rapidly growing (Photo courtesy of National Institutes of Health).

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Tests Measuring Internal Bleeding Possibly Unreliable nternal bleeding may be uncommon as a result of taking blood thinners, but the normal coagulation tests physicians use to check for the side effect of bleeding may not be reliable. Oral anticoagulants are administered at fixed daily doses, without the need for laboratory-guided adjustments, but there are limited data available on supratherapeutic doses or overdose of the oral Xa inhibitors and recently the clinical effect in patients exposed to rivaroxaban and apixaban has been characterized.

Scientists at the Nationwide Childrenâ&#x20AC;&#x2122;s Hospital (Columbus, OH, USA; www.nationwidechildrens.org) and their colleagues carried out a retrospective study and collected data from more than 800 hospitals and eight regional poison centers covering nine USA states. Data were collected on patients who contacted one of the participating poison centers between January 1, 2012, and December 31, 2014. Data were recorded at the occurrence of the case by trained specialists such as nurses, pharmacists, or physicians, during the routine management of the exposure.

Of the 223 patients involved in the study, bleeding was reported in only 15 (7%), and coagulation tests were normal in most patients with bleeding, prothrombin time (PT) 83%, partial thromboplastin time (PTT) 83%, and international normalized ratio (INR) 44%. The PT was shown to be elevated in volunteer studies with rivaroxaban and also elevated in massive overdose.

However results of the PT after use of blood thinners varied with different components.

The effects of medications on the PTT are short lived and varies based on the reagents used. In patients with bleeding, PT and PTT were elevated in one of four with rivaroxaban and none with apixaban.

In a single case with measured serum rivaroxaban concentration, the PT was recorded as 126.3 seconds. Without specific clarification of methodology and reagent use, the PT and PTT may not reliably predict risk of bleeding after rivaroxaban or apixaban ingestion. The INR was elevated in only 21% of patients tested with rivaroxaban and in no patients with apixaban. In patients with bleeding, the INR was elevated in five of eight with rivaroxaban but in none with apixaban. The use of activated clotting time also appears to be insensitive after the use Xa inhibitors.

Henry Spiller, D.ABAT, a toxicologist and coauthor of the study, said, â&#x20AC;&#x153;One way to overcome the variation in these tests is to use anti-factor Xa chromogenic assays to measure Xa plasma concentrations; however these are not widely available and a potential drawback with measuring anti-factor Xa concentrations and plasma rivaroxaban and apixaban concentrations is that the turnaround time for results may be too long to guide a treatment plan.â&#x20AC;? The study was published on August 24, 2015, in the Annals of Emergency Medicine.

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Image: The point-of-care INRatio PT/INR monitor system (Photo courtesy of Alere).

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Edited by Tahir Pillay MBChB, PhD, FRCPath(Lon), FCPath(SA)

NEWS

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

EDITORIAL

Feeding the Future of IFCC Now! 12th IFCC General Conference, Madrid, Spain (March 19-21, 2016)

by Dr. Bernard Gouget, Chair, IFCC GC Madrid 2016; Prof. Sergio Bernardini, IFCC Secretary he 12th IFCC General Conference will be held in Madrid, Spain (March 19–21, 2016) during the second year of the term of Prof. Maurizio Ferrari, IFCC President and his executive board (2015–2017). More than 250 participants will come together to celebrate innovation, imagination and inspiration and their passion for a better in health and lab medicine. The IFCC General Conference is the triennial closed meeting for the IFCC Functional Units. Its aim it to convene all the IFCC functional units at one time and location and to bridge the many scientific works where relevant research takes place, to plan and to decide on future actions of the organization.

IFCC is a dynamic organization that evolves constantly. Beside the presentation of the strategic plan and Finance, the GC Madrid 2016 program is designed to provide innovative and comprehensive overview of the latest IFCC developments. Also, we directly asked to the chairs of the Divisions, in coordination with the chairs of Committees, Working Groups and Task forces to select the topics and to present the most recent activities and projects as well as their vision on the future of laboratory medicine in the 21st Century.

The IFCC brings together more than 90 full and 12 affiliate members organized in six regions. That’s why, it is essential to convene a round table with the Presidents of six IFCC regional partners who established formal relationships to discuss the interrelation between regions and how it can be developed in the future in a spirit of solidarity, efficiency and respect for the specific characteristic of each of them.

The floor is also given the 46 IFCC Corporate members to express the IVD industry challenges and opportunities to capitalize on their strengths in line with the needs of the market in collaborating with IFCC scientists. Young scientists are carrying new blood and new ideas. A large international and Spanish delegation will be present.

They will certainly stimulate debate around the future of the lab medicine community.

The General conference is an ideal opportunity to further extend the IFCC leadership position and to meet its goal by discussing in an atmosphere of collegiality and a spirit of optimism. We are confident that the meeting will further strengthen international interdisciplinary cooperation.

We would like to express our thanks to the Societad Espanola de Biochimica Clinica y Pathiologica Molecular (SEQC)

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for welcoming us in Madrid, a beautiful and passionate city that boasts art, culture, science, sports, this makes the perfect place to celebrate the XII IFCC General conference.

Many thanks to the IFCC office, The MZ Congressi and the Madrid Convention Bureau for their invaluable collaboration and assistance.

Bernard Gouget

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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Sergio Bernardini

NEWS

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

IFCC Gears for Election of Next Executive Board (2018–2020) he procedure has commenced by the IFCC Nominations Committee: Dr. Bernard Gouget, chair; Prof. Päivi Laitinen, past Chair; Dr. Graham H Beastall, past–President; Members: Prof. Robert Christenson; Dr. Ana Leticia Maselli; Dr. Sunil Sethi.

The primary governing body of IFCC is its Council of Members, which meets once every three years. The Executive Board (EB) is responsible for the operation of IFCC, reporting to Council at each meeting. The EB operates for a three year period commencing on January 1 in the year after a Council meeting. Members of the EB are elected by the Full and Corporate Member societies of IFCC. Following decisions taken at the 2014 Council meeting in Istanbul, there will be changes to the composition of the next EB, which will commence its period of office on January 1, 2018. The process of electing this EB has commenced and this short article explains the procedure and the timetable.

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Changing composition of the Executive Board: Current EB 2015-17: President, Secretary, Treasurer, Corporate Representative, 3 Members, Past President (until 31/12/2016), President Elect (from 01/01/2017). Next EB 2018-2020: President, Secretary, Treasurer, Corporate Representative, 6 Regional Members, Past President (until 31/12/2019), President Elect (from 01/01/2020).

The significant change for the current EB is that the President Elect will be elected during 2016 in order to join EB on January 1, 2017. The President Elect will be confirmed as President of the next EB commencing one year later (January 1, 2018).

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It is the procedure for choosing the President Elect that has just begun.

The significant change for the next EB is that the three Members, currently elected by all Full Members of IFCC, will be replaced by six Regional Members – one for each of the six IFCC Regional Federations.

The IFCC Full Members in each Regional Federation will be the electorate to choose their Regional Member of EB. The procedure for electing Regional Members of EB will occur during 2017.

Procedure for election of next IFCC President: The election of the next IFCC President is taking place during 2016 with the election of the President-Elect who will serve one year (2017) shadowing the current EB before becoming President. The timetable for this election is as follows: February 1, 2016: Call for nominations issued ; April 30, 2016: Nominations close; May 2016: IFCC Nominations Committee determines eligibility of nominees; June 2016: Slate of candidates published; September 1–30, 2016: Electronic ballot to choose the President Elect; October 2016: Result of election announced.

Nominations must be made on the form that has been issued to IFCC Full Members and must be submitted by an IFCC Full Member. Individuals with an interest in suggesting nominees should discuss the matter with their Full Member society. All Full Members will vote electronically using the IFCC Alternate Vote system.

Procedure for election of Secretary and Treasurer The procedure for electing the Secre-

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tary and Treasurer will be similar to that used to elect the President but will take place at a later date. The timetable will be: May 15, 2016: Call for nominations issued; December 31, 2016: Nominations close; January 2017: IFCC Nominations Committee determines eligibility of nominees; February 2017: Slate of candidates published; April 1–30, 2017: Electronic ballot to choose the Secretary and Treasurer; May 2017: Result of election announced.

Nominations must be made on the form that will be issued to IFCC Full Members and must be submitted by an IFCC Full Member. Individuals with an interest in suggesting nominees should discuss the matter with their Full Member society. All Full Members will vote electronically using the IFCC Alternate Vote system.

Procedure for election of Corporate Representative The procedure for electing the Corporate Representative on the IFCC EB will be similar to that used to elect the Officers. In this case, the electorate is IFCC Corporate Members. The timetable will be: January 1, 2017: Call for nominations issued; March 31, 2017: Nominations close; April 2017: IFCC Nominations Committee determines eligibility of nominees; April 2017: Slate of candidates published; June 1–30,

2017: Electronic ballot to choose the Corporate Representative; July 2017: Result of election announced.

Nominations must be made on the form that will be issued to IFCC Corporate Members and must be submitted by an IFCC Corporate Member. Individuals with an interest in suggesting nominees should discuss the matter with their Corporate Member society.

All Corporate Members will vote electronically using the IFCC Alternate Vote system.

Procedure for election of Regional Members The procedure for the election of the six Regional Members of the IFCC EB is under active discussion with Regional Federations. The call for nominations will commence in June 2017 with the elections completed by the end of September 2017.

Each IFCC Regional Federation will elect one Regional Member of the IFCC EB. The electorate will be IFCC Full Members in the Regional Federation.

Final words This article sets out in a transparent way the procedure and timetable for electing the IFCC Executive Board for period 2018–2020. Individuals seeking clarification or additional information should contact the Chair of the IFCC Nominations Committee via ifcc@ifcc.org

IFCC TF Young Scientists in Latin America At 22nd COLABIOCLI in Quito (EC) he 22nd COLABIOCLI in Quito, Ecuador, September 24-26, 2015, was the first kickoff for Young Scientist in Latin America (LA) to start thinking in creating a regional group of IFCC TFYS. Although Latin American countries are different from north to south, there is one main strength that keeps united as “Patria Grande” and this is Language!

During the open ceremony, a member of the IFCC TF-YS talked about the activities that the group is promoting and developing; and encouraged young scientists to: Get involved, Participate and Commit themselves with Professional Institutions. In addition, he asked the institutions to Listen, Include and Consider YS (Young Scientists) in their committees.

After the ceremony and during the congress, many professionals from Argentina, Mexico, Ecuador, Colombia and Honduras among other countries were enthusiastic to learn more about the IFCC TF-YS activities and how they could be involved.

The online radio “El Microscopio” is a useful tool that improves communication, participation and interaction

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among YS around the world. Nevertheless, at the WG-IANT meeting held during the congress, the scientific magazine “Diagnostico In Vitro” offered a section for the IFCC TF-YS. This section will help communicate the activities of the LA YS group and information about the National YS groups in the region.

Special thanks for Dr. Maria del Carmen Pasquel, 22nd COLABIOCLI Congress President, for the invitation and making this possible.

by Santiago Fares Taie, Member IFCC TF-YS LabMedica International February-March/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

NEWS

IFCC General Conference Madrid 2016: Debate Dinner with Demosthenes Panagiotakos emosthenes Panagiotakos, Dr. Med., FRSPH, FACE Professor of epidemiology and nutrition at the Harokopio University in Athens, Greece, will give an invited lecture during the official dinner on “The protective role of Mediterranean diet on cardiovascular disease, risk: Environmental Health Perspectives.”

Cardiovascular Disease (CVD) remains the leading cause of death and disability worldwide, with increased hospital discharge rates, possessing a serious public health issue and an economic burden. Recent demographic transitions, including aging of the population, low fertility, urbanization and shift towards unhealthy behaviors have resulted in tremendous increase in the prevalence of several cardiometabolic disorders (i.e., hypertension, obesity, diabetes). According to WHO, and other international Organizations’ reports, a substantial number of cardiac episodes could have been prevented through lifestyle modifications (i.e., diet, physical activity, smoking cessation). Regarding secondary prevention, it is

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well documented that effective cardiovascular rehabilitation requires a multidisciplinary approach, including medical treatment, as well as proper lifestyle changes. Diet has been recognized as one of the most important modifiable and preventable factors, being undoubtedly beneficial in primary prevention, as well as among cardiac patients. However, studies among CVD patients are scarce, and with inconclusive results. The most studied dietary pattern is the Mediterranean-type diet, with several observational studies and clinical trials demonstrating its protective role against first, as well as recurrent cardiac events, whereas evidence regarding other well-known models, including Western-type, Vegetarian, Asian-type and Dietary Approaches to Stop Hypertension (DASH) diet, are rather limited. Despite the important findings from numerous of studies, there is no doubt that the Mediterranean diet is being progressively lost, especially in the younger generations. Therefore, immediate actions are needed by public policy

Dr. Demosthenes Panagiotako

Prof. Damien Gruson

makers in order to preserve the wisdom of our ancestors.

The debate will be coordinated by Prof. Damien Gruson, PhD, EUSpLM, FESC, professor of biochemistry and endocrinology, department of laboratory medicine of the Cliniques Universitaires Saint Luc, Brussels and member of the research unit on Endocrinoly Diabetes and Nutrition (EDIN) unit of the Catholic University of Louvain (UCL).

Damien Gruson has already caught people’s eyes as an up-and-coming brilliant scientist in the fields of lab medicine, doing exciting things now

and with promise for even more in the future. The new generation has a bold and integrated vision to lead the lab medicine revolution in a collaborative spirit and to foster multidisciplinary collaboration within the European and international federations. There is no doubt at all that the discussion will be held with wit and insight, eloquence and a great sense of humor in collaboration with the team of the young scientists: Dr. Pradeep DABLA, chair IFCC TF-YS, his international group and Guilaine BOURSIER as a liaison with the Spanish group.

IFCC Welcomes Iran’s IACLD As New Affiliate Member

by Dr. Mohammad Reza Bakhtiari Vice Chairman, International Affairs, IACLD he Iranian Association of Clinical Laboratory Doctors (IACLD) was founded by the first DCLS graduates in 1992. Since 1986, setting up and commencing a doctorate program in Clinical Laboratory Sciences (DCLS) in Iran, has created new opportunities for professional development in multiple domains of clinical laboratory including clinical center laboratories, public and private laboratories, research organizations and university laboratories. After in-depth discussion, the DCLS program was approved by the Medical Committee of Iran’s Cultural Revolution Supreme Council in 1986.

From 1986 to 1994, about 1300 people were trained as DCLS students. The DCLS Dr. Mohammad Reza Bakhtiari graduates have revolutionized the medical laboratory industry in Iran and improved the quality of laboratory services across the country. With regard to the needs for modernization and transformation in the structure of Iranian medical laboratories in accordance with requirements and expectations of the modern world, IACLD was established by the first DCLS graduates in 1992. The main goal of IACLD is to improve the quality and strengthen the position of Iranian clinical laboratories as well as related human resources in the national and international arena. DCLS degree holders as the members of IACLD act as effective common interfaces among clinicians, medical researchers and health care policy makers. Among their numerous functions, the following contributions are highlighted: (1) Contribution to patient care: as Laboratory Directors by establishing Clinical laboratories and performing routine and specialized diagnostic tests based on standard algorithms as well as knowledge in the fields of clinical laboratory diagnoses. (2) Education and Training: by acting as university faculty members / lecturers in medical laboratory sciences. (3) Research: by conducting basic and clinical studies as well as transferring research findings into practice. (4) Assisting the health care policy makers: by participating in decision and policy making and providing practical recommendations for relevant authorities. (5) Quality Improvement: by establishing one of the main organizations for Proficiency Testing in Iran.

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EFLM CORNER

European Federation of Clinical Chemistry and Laboratory Medicine

12th Czech National Congress Held in Brno

by Prof. Jaroslav Racek, MD, DSc, President of the Czech Society of Clinical Biochemistry; Assoc. Prof. Milan Dastych, MD, PhD, President of the 12th Congress of the Czech Society of Clinical Biochemistry he 12th National Congress of the Czech Society of Clinical Biochemistry with International Participation was held on September 20–22, 2015, in Brno, the largest Moravian city.

The main topic of our congress was the issue of clinical application of laboratory activities, cooperation with clinical colleagues and their views of the classical clinical-biochemical domains. Five out of eight thematic sections were devoted to this subject.

The organizing committee chose eight current topics, and guarantors of single lecture blocks managed to attract real experts in given problems. Besides clinical chemists, the lectures were held by experts in other branches of laboratory medicine and colleagues from clinical disciplines.

The professional program was supplemented by two plenary lectures of leading foreign experts, almost forty scientific posters and traditionally by an exhibition of almost thirty companies dealing with

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laboratory instruments and reagents, and finally by numerous workshops. Abstracts of both lectures and posters were published in No 3 of Klinická biochemie a metabolismus, the official journal of the Czech Society of Clinical Biochemistry.

The congress was commenced by the plenary lecture of Associate Professor P. Stern on a broadly conceived interdisciplinary theme of applied immunochemistry.

Two other plenary lectures were dedicated to advancement and future of molecular biology in laboratory diagnostics.

Prof. Maurizio Ferrari, IFCC President, Hospitale San Raffaele, Milan, gave a lecture entitled “The future of molecular biology in the diagnostic laboratories.”

Prof. Michael Neumaier, DGKL President, Medizienische Fakultät Mannheim der Universität Heidelberg, presented the second plenary lecture enti-

Photo: The congress presidium (from the right): Prof.

Jaroslav Racek, president of CSKB, Prof. Tomas Zima, CSKB and EFLM board member, Associate Professor Milan Dastych, scientific secretary and president of the congress

tled “Advances in molecular diagnostics and their respective analytical quality assurance.”

The second day professional program continued with blocks of lectures in which our leading experts in both clinical and laboratory medicine informed the auditorium about novelties in osteology, cardiology, hepatology and intensive care medicine: “Cooperation of clinical biochemistry with clinical osteology”; “Cardiomarkers in the clinic and in the experiment during 2015”; “Laboratory examinations in hepatology”; “Internal environment with a view of specialists from various branches”; “Dyslipidemia and atherosclerosis: laboratory and clinical aspects.”

The second day of the congress was traditionally closed with the plenary meeting of the members of the Czech Society of Clinical Biochemistry.

The scientific program of the last day continued with a series of lectures dealing with laboratory quality, laboratory automation and POCT: “Indicators of analytical quality in clinical laboratory”; “Automation and robotization in a laboratory – the present and future”; “POCT – clinical laboratories partner?”

The congress always presents the opportunity to award the outstanding individuals in clinical chemistry who significantly contributed to a good reputation of the Czech Society of Clinical Biochemistry (CSKB) both in this country and abroad. Assoc.

Prof. Petr Stern was awarded the highest prize of the CSKB, the Medal of Prof. Horejsi. The Honorary Membership was awarded to Prof. Maurizio Ferrari, Italy, Prof. Michael Neumaier, Germany and Dr. Petr Kocna, Czech Republic. The award for the best paper in clinical chemistry was granted to Prof. Marta Kalousova et al. (paper title: Pregnancy-associated plasma protein A associates with cardiovascular events in diabetic hemodialysis patients). As the best educational publications in clinical chemistry of the 2014 were selected both e-learning by Dr. Miroslava Benovská et al. Microscopic analysis of urine” and the textbook by Dr. Norbert Cibicek et al.: “Principles and application of selected analytical methods in laboratory medicine.”

The congress became the venue not only for lecture blocks but also for social meetings and informal discussion with colleagues and friends.

Welcome Evening at the concert hall of Besedni dum offered participants the “Modern architecture in Brno” lecture and a Concert of Works by J. Bendy and P.I. Tchaikovsky. Also Evening Party with Moravian wine tasting and folk music ensemble was the opportunity for an informal meeting.

We believe that the 12th Brno congress will rank among the successful projects of the Czech Society of Clinical Biochemistry and the whole Czech Medical Association.

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EFLM CORNER

European Federation of Clinical Chemistry and Laboratory Medicine

Change of Guard at EFLM Committee Chairs Thanks to Outgoing EFLM Committee Chairs:

Prof. Elizabeta Topic (Croatia)— Chair of the EFLM Education and Training Committee 2010–2015

by Ana-Maria Simundic lizabeta Topic has finished her third term as a chair of the EFLM Committee for Education and Training (C-ET). During the long six years of her office, Prof. Topic has made a substantial contribution to the work of EFLM, its C-ET committee and its working groups. Thanks to her chairmanship, we have seen many outcomes which have received the appreciation by the EFLM Executive Board as well as by many colleagues throughout the EFLM National Societies.

Prof. Topic has built a recognizable postgraduate course in Dubrovnik which has over the years grown into the favorite venue for young colleagues and other professionals eager to learn new things and acquire knowledge. She was also involved into the creation of the various guidelines and documents which have enabled EFLM to better manage its meetings, grant applications, etc. Prof. Topic was a valuable member of many committees which have been involved in the communication and collaboration of EFLM with other international associations, such as IFCC, UEMS and some others. Her experience and knowledge had helped EFLM to strengthen its role and significance within Europe and serve the educational needs of its Member Societies.

Executive Board wishes to formally thank her, for the contribution she has made to EFLM as Chair of the Committee for Education and training.

Her contribution will remain a valuable resource for the future and will be very useful to the new incoming C-ET chair, Prof. Ralf Lichtinghagen (Hannover, Germany).

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Prof. Elvar Theodorsson (Sweden)—Chair of the EFLM Science Committee 2014–2015

by Sverre Sandberg lvar Theodorsson has served one term of two years as the chair of the Science Committee (C-S) of EFLM and has decided not to apply for a second term. During his period as chair of the Committee he has been an inspiration for all the working groups (WG) in the committee. He has a specific way of dealing with people, being always kind, respectful and tried to find the best compromise and avoid conflicts. He always looked at people and treated them individually and not by the book (or by the rules). People liked him and he was a nice person to work with. He had a close contact with the chairs of the WGs and stimulated and encouraged them in their work.

Also he had refreshing ideas as for example to gather all WG chairs and listen to their views and suggestions. He is a very able team builder and as one of the WG chairs put it like this: ”…he made you feel that you belong to an organization that really cares and that respects your expertise.” And indeed, it is really important for EFLM to show that we appreciate all the voluntary work that people is doing.

Elvar also had a good communication with the EFLM Executive Board telling them straightforward his opinions and ideas so that we could be able to develop EFLM activity. With his huge experience, he was a great resource in many different and difficult questions. He was a driving force for EFLM to engage in applications for European grants. We do hope that EFLM also in the future will have the opportunity to use the expertise of Elvar to the benefit of its members.

His contribution will remain a valuable resource for the future and will be very useful to the new incoming C-S chair, Prof. Eric Kilpatrick (Doha, Qatar).

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Welcome to New EFLM Committee Chairs:

Prof. Eric Kilpatrick (UK)

Prof. Ralf Lichtinghagen (Germany)

FLM is delighted to welcome the new Chair of the Science Committee (Prof. Eric Kilpatrick) and the new Chair of the Education & Training Committee (Prof. Ralf Lichtinghagen) wishing them all the best for their future contribution to the Federation. EFLM is sure that the professional competence and the personal attitudes of the two new Chairs could assure a great success to the EFLM activities. Here below, some information on Prof. Kilpatrick and Prof.

Lichtinghagen.

Prof. Kilpatrick is the Division Chief in Clinical Chemistry at Sidra Medical and Research Center in Qatar. He is also the honorary Professor of Clinical Biochemistry at Hull York Medical School and is the Past President of the Association for Clinical Biochemistry and Laboratory Medicine (ACB) in the UK. After graduating in medicine from the University of Glasgow in 1988 he trained in Clinical Biochemistry in Glasgow and then Manchester before being appointed as the consultant Head of Department of Clinical Biochemistry at Hull Royal Infirmary in 1998, subsequently becoming the Clinical Director for Pathology. In 2015 he moved to become the inaugural Division Chief for Clinical Chemistry at Sidra. Prof. Kilpatrick’s other leadership roles include being Chair of UK national audit in his field of medicine between 2004 and 2010 as well as providing expert advice to the UK Government and the National Institute for Health and Care Excellence (NICE) on aspects of diabetes care. He has also represented the UK on global task forces related to diabetes and laboratory medicine.

Academically, he gained his higher MD degree from Glasgow in 1996, with his thesis combining his interest in the laboratory medicine and clinical diabetes. Since then, he has be-

come an international authority on assessing glucose control in diabetes and has published about 150 peerreviewed articles, contributing, in 2006, to him becoming the first honorary full Professor from Hull at Hull York Medical School. He has additionally gained recognition with international lectures and awards from countries such as the UK, Canada, and Australia.

Prof. Lichtinghagen received his doctorate at the Ruhr-University Bochum and started his continuing education in Clinical Chemistry in 1991. Now he is Deputy in the Institute of Clinical Chemistry and Director of the MTLA-School of the Hannover Medical University.

He has been Member-at-Large of the Executive Board of the German Society of Clinical Chemistry and Laboratory Medicine (DGKL). Currently, he plays an active role in the commission for recognition of the qualification “Clinical Chemist” by the DGKL as well as in the working group on bioinformatics of the DGKL. He has a long standing experience in the field of laboratory management as well as professional education. He is actively involved in research and development in Laboratory Medicine as documented by many publications in internationally renowned journals.

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European Federation of Clinical Chemistry and Laboratory Medicine

Report on 9th Spanish National Congress ith the aim to share knowledge and scientific experiences and daily achievements, around 1,500 professionals gathered together on October 7–9, 2015, in Madrid at the IX National Congress of Clinical Laboratory, which is organized in conjunction with the Spanish Society of Clinical Biochemistry and Molecular Pathology (SEQC), the Spanish Association of Medical Biopathology (AEBM) and the Spanish Association for Analyst Pharmaceuticals (AEFA).

The Congress, which is a leader on a national scope in the field of clinical analysis, is supported by front line speakers and an important number of activities of great interest, like 4 pre-congress courses, 2 conferences, 10 symposiums, 12 workshops, 2 meetings for the residents and 2 expert brunches.

Furthermore, it is an opportunity for experts to see the latest technological progress being made, on site, and to discuss the innovative and cutting-edge trends in pre-analysis, circulating DNA, point of care, genet-

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ics, patient safety, etc.

Within the symposiums, the focus of their dedication to “doing what needs to be done” is evident, a topic that is also covered in a precongress course, in which the undertaking of unnecessary laboratory tests was discussed, as well as strategies to shape the demand using laboratory information systems and/or by means of electronic request systems.

“The focus that we have chosen for the Congress on this issue reflects that clinical laboratory companies are aligned with the Commitment to Quality on behalf of Scientific Companies in Spain project, coordinated by the Ministry of Health, Social Services and Equality”, highlighted Dr. Bernabéu, member of the Organizing Committee of the Congress, as well as of the Management Board for SEQC. New to the congress were also 2 expert brunches, aimed at issues that have a great impact on laboratory work: leadership and patient safety.

News from EFLM National Societies Danish Society of Clinical Chemistry (Dansk Selskab for Klinisk Biokemi) The new President of the Danish Society of Clinical Chemistry is Dr. Henrik L. Jorgensen (Dept. of Clinical Biochemisty, Bispebjerg University Hospital, Copenhagen) replacing Dr. Nete Hornung, while the new EFLM National Representative is Dr. Peter H. Nissen (Molecular Genetics Unit, Dept. of Clinical Biochemistry, Aarhus University Hospital) replacing Dr. Anders Johnsen. A warm welcome in EFLM to the new representatives of the Dansk Selskab for Klinisk Biokemi!

French Society of Clinical Biology (Société Française de Biologie Clinique) This is to announce that SFBC has a new President, Prof. Marc Delpech (replacing Prof. Joelle Goudable).

Marc Delpech is professor of Biochemistry and Molecular Biology at the Paris Descartes Medical School (Paris Descartes University), associated professor at the Medical school of the Jiao Tong University of Shanghai and head of the Paris Descartes— Paris Diderot Universities PhD school: “Genetics, Cell, Immunology, Infectiology and Development, Gc2iD.” Prof. Delpech is the head of the Cochin hospital Biochemistry and Molecular Genetics laboratory, a laboratory devoted to prenatal diagnosis and genetic counselling of rare hereditary diseases. He is the head of the department “Biology, Pharmacy, Pathology” of Cochin University hospital. His main research topics are molecular Genetics of rare hereditary diseases and more specifically auto-inflammatory syndromes and amyloidosis. He is a member of several Scientific Committees (French Association “Deafest cystic fibrosis,” French Biomedicine

Agency and many others). He is a member of the French National Academy of Medicine. A warm welcome in EFLM to the new SFBC President!

German Society of Clinical Chemistry and Laboratory Medicine (DGKL) The new President of the German Society of Clinical Chemistry and Laboratory Medicine is Prof. Berend Isermann (Faculty of Medicine, Otto-vonGuericke-University Magdeburg, Inst. for Clinical Chemistry and Pathobiochemistry, Magdeburg) replacing Prof.

Michael Neumaier, while the new EFLM National Representative is Prof.

Michael Vogeser (Institute of Laboratory Medicine, Hospital of the LudwigMaximilians-University of Munich) replacing Prof. Klaus Kohse. A warm welcome in EFLM to the new DGKL representatives!

Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC Laboratory Medicine) The new President of the Italian National Society “SIBioC—Laboratory Medicine” is Prof. Marcello Ciaccio (Dept. of Medical Biotechnologies and Forensic Medicine, Faculty of Medicine, University of Palermo) replacing Prof. Ferruccio Ceriotti. A warm welcome in EFLM to the new SIBioC President!

Slovak Society of Clinical Biochemistry (Slovenská spoloCnosť klinickej biochémie) The new President of the Slovak Society of Clinical Biochemistry is Prof.

MUDr. Oliver Rácz (Dept. of Pathophysiology, Faculty of Medicine, Pavol Jozef Safárik University in Kosice) replacing Dr. Katarína Danová. A warm welcome in EFLM to the new SSKB President!

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Industry News

Alere Acquisition Propels Abbott To POC Diagnostics Leadership bbott Inc. (Abbott Park, IL, USA; www.abbott.com) and Alere Inc. (Waltham, MA, USA; www.alere.com) have reached a definitive agreement under which Abbott will pay an equity value of about USD 5.8 billion to acquire Alere. Once the transaction is completed, Abbott will become the leading diagnostics provider of point-of-care (POC) testing.

Abbott’s diagnostics presence and leadership will be significantly advanced as Alere's complementary technologies will help Abbott provide better care for patients by providing fast, accurate, and actionable medical information to help guide decision-making.

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Under the terms of the agreement, Abbott will pay USD 56 per common share at a total expected equity value of USD 5.8 billion. The transaction will be immediately accretive to Abbott's ongoing earnings-per-share upon close and significantly accretive thereafter. Alere will become a subsidiary of Abbott.

The combined business will offer the broadest POC menu of infectious disease, molecular, cardiometabolic, and toxicology testing, expanding Abbott's platforms to include benchtop and rapid strip tests. Abbott will better serve an expansive customer base while also accelerating innovation.

Euro Diagnostica to Produce and Distribute Arquer’s Bladder Cancer Test rquer Diagnostics Ltd. (Sunderland, UK; www.arquerdx. com), a company which has developed a high-sensitivity, highspecificity, ELISA-based urine test for cancer, has signed an agreement with Euro Diagnostica AB (Malmo, Sweden; www.eurodiagnostica.com) for the manufacturing and supply of Arquer’s Mcm5-ELISA test for the diagnosis of bladder cancer.

Bladder cancer is currently diagnosed by cystoscopy, which is expensive and uncomfortable for patients.

Arquer’s Mcm5-ELISA is a simple, noninvasive test, that detects the presence of minichromosome maintenance complex component 5 (Mcm5) protein in urine. MCM proteins are shed into urine by both prostate and bladder tumors and are known to be excellent biomarkers of

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cancer, being directly involved in cell replication. Arquer’s diagnostic test originates from work conducted by Cambridge University (UK) and Cancer Research Technology (CRT; UK).

Dr. Ian Campbell, CEO, Arquer Diagnostics, commented: “This agreement is an important milestone for Arquer, as we move towards European regulatory approval and prepare for the commercial launch of the Mcm5ELISA test later this year. With Euro Diagnostica’s experience in the manufacture of ELISA kits, we are confident that this relationship will allow us to bring the Mcm5-ELISA test to market in the most efficient, rapid, and cost effective manner possible, to benefit both patients and clinicians.” Under the terms of the agreement, Arquer intends to use Euro Diagnostica as primary manufacturer of its Mcm5-ELISA kits.

IVD Sector in India Projected for Continued Growth ccording to a new report, the in vitro diagnostic (IVD) testing sector in India is estimated to have reached USB 782 million in 2015, while modernizing healthcare infrastructure and steady migration from manual to automated processes are expected to support additional growth.

The report “IVD in India” by Kalorama Information (New York, NY, USA; www.kaloramainformation. com) places India and its IVD market in context with the developing world in terms of diseases, economic and healthcare system development, and other key metrics related to health expenditures and diagnostics.

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“India will continue to offer one of the better markets for IVD products among emerging nations because of its economic stability,” said Bruce Carlson, publisher of Kalorama Information.

India has the world’s 7th-largest economy by nominal gross domestic product (GDP), 3rd largest by purchasing power parity, and a stable growth rate averaging approximately 7% for the last 2 decades. Its longterm growth prospects are considered moderate due to its young population, corresponding low dependency ratio, healthy savings and investment rates, and increasing integration into the global economy.

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International Calendar Jun 28-Jul 1; Bogota, Colombia; Web: http:// feriameditech.com

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