LabMedica International April 2019 by Globetech

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WORLD’S CLINICAL LABORATORY NEWS LEADER ISSN 1068-1760

Vol. 36 No.2 • 4/2019

DAILY CLINICAL LAB NEWS

Tau Blood Test for Alzheimer’s Disease

Newborn Genomic Sequencing Detects Disease Risk Factors

resently, the only way to definitively diagnose Alzheimer’s disease is through brain scans and tests of cerebrospinal fluid collected via lumbar puncture. Though cumbersome and expensive, such procedures provide the most accurate diagnoses for patients.

enomic sequencing provides many opportunities in newborn clinical care, but the challenges of interpreting and reporting newborn genomic sequencing (nGS) results need to be addressed for their broader and effective application.

Recent advances in genomic sequencing (GS) have raised the possibility of its routine implementation in newborn care. Newborn GS (nGS) provides many potential opportunities in the clinical management of a newborn. First, it might identify risk for a broad

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Phenotypic Test Identifies Antibiotic-Resistant Bacterial Infections

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iquid biopsy for plasma circulating tumor DNA (ctDNA) next-generation sequencing (NGS) is commercially available and increasingly adopted in clinical practice despite a paucity of prospective data to support its use. Plasma ctDNA harboring somatic mutations are highly specific for cancer and may serve as a useful surrogate of tumor burden, intratumor heterogeneity, and

rostate cancer (PCa) is one of the most common types of malignancy worldwide and is the second leading cause of cancer death among men. This cancer tends to be asymptomatic and slow growing, often with onset in young men, but usually not detected until the age of 40 to 50 years. The conventional methods for PCa screening recommended by the American Cancer Society are Cont’d on page 4

Advanced System Brings Integrated Solution to Clinical Flow Cytometry

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he newly-launched ClearLLab 10C clinical flow cytometry system offers an integrated solution, featuring standardized workflow that delivers greater consistency and reliability in clinical findings, and simplifies clinical QC reporting.

Clinical News . . . . 4-26 IFCC News . . . . . . . . 27 Product News . . 10-26 Industry News . . . . 33 Events Calendar . . . 34

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Transfusions with Older Blood Linked to Adverse Events

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Liquid Biopsy Identifies Lung Cancer Drivers

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Urinary Detection Method For Prostate Cancer

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arbapenemase-Producing Organisms (CPO) are gramnegative bacteria that are resistant to antibiotics for severe or high-risk bacterial infections. Instead of manual detection that took up to four days, the CPO Detect test can now offer results in less than 36 hours, enabling earlier implementation of infection control and therapy procedures.

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fter a serious injury, the leading cause of death is loss of blood. Major trauma victims who receive transfusions of packed blood 22 days old or older may face increased risk of death within 24 hours, according to a new study. A blood transfusion is a safe,

common procedure in which blood is given through an intravenous (IV) line in one of the blood vessels. Major trauma victims can require massive transfusions of blood or blood products in a very short time. Clinical effects of stored blood toxicity include Cont’d on page 6

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Phenotypic Test Identifies Antibiotic-Resistant Bacterial Infections arbapenemase-producing organisms (CPO) are gram-negative bacteria that are resistant to the carbapenem class of antibiotics, which are commonly used for severe or high-risk bacterial infections. Mortality related to CPO infection is quite high around the world, with reported rates from 22% to 72%. A CPO detect test, which offers results in less than 36 hours, is expected to replace time-consuming, manual detection that can take up to 96 hours for results. The CPO detection test will be offered as part of the BD Phoenix gram-negative panels, which already use susceptibility testing to expose bacteria from a specific patient’s infection to a variety of potential treatments or candidates to gauge how they respond. The BD Phoenix CPO detect test (Becton, Dickinson and Company, Franklin Lakes, NJ, USA; www.bd.com) has gained US Food and Drug Administration (FDA, Silver Springs, MD, USA; www.fda.gov) clearance. The test may help hospitals contain the spread of antimicrobial resistance (AMR) by shortening the time it takes to detect CPOs, thereby enabling the earlier implementation of infection control procedures and the initiation of appropriate antibiotic therapies designed for treating these infections.

serum prostate specific antigen (PSA) testing and digital rectal examination (DRE). However, these methods have some drawbacks due to their sensitivity, specificity and accuracy. The PCA3 gene has shown promise as a noninvasive PCa biomarker. Scientists at Mahidol University (Bangkok, Thailand; https://mahidol.ac.th) collected spot urine samples from five healthy male volunteers, first voided post-DRE urine from five benign prostate hyperplasia (BPH) patients and from five PCa patients. Diagnosis of patients was made by histopathological analysis after prostate biopsy subsequently. PCa patients were identified with positive biopsy. Total RNA was isolated from the cell pellets of urine as well as from cell lines and total RNA was converted to cDNA using RevertAid First Strand cDNA synthesis kit (Thermo Fisher Scientific, Waltham, MA, USA; www. thermofisher.com). The team developed an assay based on interactions between unmodified gold nanoparticles (AuNPs) and thiolated polymerase chain reaction (PCR) products. Thiolated PCR products were amplified by RT-PCR using a thiol-labeled primer at the 5 end. Thiolated products of PCA3 bound to the surface of AuNPs and led to the prevention of salt-induced aggregation (red color). In the absence of the PCR products, AuNPs changed their col-

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Steve Conly, vice president and general manager of Microbiology for BD Diagnostic Systems, said, “The BD Phoenix CPO detect test gives laboratories an accurate and cost-effective method to rapidly identify CPOs and support patient management. Along with the BD Phoenix M50 instrument, this automated first-to-market, phenotypic test to detect CPOs, using the BD Phoenix system, expands the BD portfolio of solutions for identification and antimicrobial susceptibility testing and is another example of the company’s commitment to providing solutions that help addressing the global burden of antimicrobial resistance.” Image: The BD Phoenix identification and susceptibility combo panels (Photo courtesy of Becton, Dickinson and Company).

Urinary Detection Method for Prostate Cancer cont’d from cover

or from red to blue due to the salt-induced aggregation. These changes were detected by the naked eye and a microplate spectrophotometer (BioTek Inc, Winooski, VT, USA; www. biotek.com). The team reported that assay was specific for PCA3 in prostate cancer cell lines with a visual detection limit of 31.25 ng/reaction. The absorption ratio 520/640 nm was linear against PCR product concentration in the reaction. This method is promising for discrimination of prostate cancer patients from both healthy controls and benign prostatic hyperplasia patients according to their urinary PCA3 expression levels. The results indicated that the proposed colorimetric assay was more sensitive than gel electrophoresis. The authors concluded that a sensitive and specific AuNP-based colorimetric method for visual detection of PCA3 in prostate cancer was successfully developed. This new method was based on interactions between thiolated PCR products and unmodified AuNPs. The positive and negative results were clearly distinguished by the naked eye, being red and blue color, respectively. The incubation time was short and results were obtained within 10 minutes of RT-PCR completion. Moreover, a large number of samples could be tested simultaneously in 96-well microtiter plates. The study was published in the January 2019 issue of the journal Clinica Chimica Acta.

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ISSN 1068-1760 Vol.36 No.2. Published, under license, by Globetech Media LLC; Copyright © 2019. 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. Teknopress Yayıncılık ve Ticaret Ltd. Şti. adına İmtiyaz Sahibi: M. Geren • Yazı işleri Müdürü: Ersin Köklü Müşir Derviş İbrahim Sok. 5/4, Esentepe, 34394 Şişli, İstanbul P. K. 1, AVPIM, 34001 İstanbul • E-mail: Teknopress@yahoo.com Baskı: Postkom A.Ş. • İpkas Sanayi Sitesi 3. Etap C Blok • 34490 Başakşehir • İstanbul Yerel süreli yayındır. Yılda sekiz kere yayınlanır, ücretsiz dağıtılır.

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Liquid Biopsy Identifies Lung Cancer Drivers contâ&#x20AC;&#x2122;d from cover

response to therapy. Genetic sequencing is particularly important in patients with advanced-stage non-small cell lung cancers as their tumors may harbor somatic alterations that are sensitized to targeted therapies. A large international team of scientists collaborating with the Memorial Sloan Kettering Cancer Center (New York, NY, USA: www. mskcc.org) enrolled a total of 210 consecutive patients with advanced non-small cell lung cancer, and the majority of patients had adenocarcinoma histology (192/210, 91.4%). Patients were predominantly female (124/210, 59.0%). All patients had metastatic disease at the time of plasma NGS genotyping. Most patients (171/210, 81.4%) had prior conventional molecular tumor testing (immunohistochemistry, PCR fluorescence in situ hybridization for EGFR, ALK, and ROS1) performed and resulted on tissue at the time of plasma NGS testing. For 106 of the cases, they also had access to targeted NGS data across 468 cancer-related genes, generated on tumor tissue biopsy samples analyzed with the Memorial Sloan Kettering-Integrated Mutation Profiling of Actionable Cancer Targets (MSK-IMPACT) capture assay. Sufficient tumor tissue was not available for molecular testing in 39 of the cases. A subset of patients who had an alteration identified on ResBio plasma ctDNA NGS underwent orthogonal plasma testing with an anchored multiplex PCR assay based on Rapid Amplification of ctDNA Ends (RACE) strategy (Resolution Bioscience, Redmond, WA, USA; www.resolutionbio. com). Additionally, the team assessed a subset of the blood plasma samples with an Archer RACE NGS assay (ArcherDx, Boulder, CO, USA; https:// archerdx.com) to verify the accuracy of the ctDNA findings. The team detected somatic mutations in 64.3% (135/210) of patients. Circulating tumor DNA detection was lower in patients who were on systemic therapy at the time of plasma collection compared with those who were not (30/70, 42.9% versus 105/140, 75.0%). The median test turnaround time (TAT) of plasma NGS was shorter than tissue NGS (9 versus 20 days). Patients who tested plasma NGS positive for oncogenic drivers had tissue NGS concordance of 96.1% (49/51) and directly led to matched targeted therapy in 21.9% (46/210) with clinical response. The authors concluded that plasma ctDNA NGS detected a variety of oncogenic drivers with a shorter TAT compared with tissue NGS and matched patients to targeted therapy with clinical response. Positive findings on plasma NGS were highly concordant with tissue NGS and can guide immediate therapy; however, a negative finding in plasma requires further testing. The study was published on November 28, 2018, in the Journal of the National Cancer Institute.

LabMedica International April/2019

Image: The Rapid Amplification of ctDNA Ends (RACE) next-generation sequencing (NGS) assay (Photo courtesy of ArcherDx).

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Transfusions with Older Blood Linked to Adverse Events cont’d from cover

elevated risk of clot formation, infection, sepsis, organ failure and death. A team of medical scientists led by those at the University of Alabama at Birmingham (Birmingham, Al, USA; www.uab.edu) analyzed data from the Pragmatic, Randomized Optimal Platelet and Plasma Ratios trial. Subjects in the parent trial included critically injured adult patients admitted to 1 of 12 North American Level I trauma centers who received at least one unit of packed red blood cells (RBCs) and were predicted to require massive blood transfusion. The primary exposure was volume of packed RBC units transfused during the first 24 hours of hospitalization, stratified by packed RBC age category: 0 to 7 days, 8 to 14 days, 15 to 21 days, and greater than or equal to 22 days. The primary outcome was 24-hour mortality. The team also evaluated the association between transfused volume of each packed RBC age category and 24-hour survival, using random-effects logistic regression, adjusting for total packed RBC volume, patient age, sex, race,

mechanism of injury, Injury Severity Score, Revised Trauma Score, clinical site, and trial treatment group. The investigators reported that the 678 patients included in the analysis received a total of 8,830 packed RBC units. One hundred patients (14.8%) died within the first 24 hours. On multivariable analysis, the number of packed RBCs greater than or equal to 22 days old was independently associated with increased 24-hour mortality (adjusted odds ratio [OR] 1.05 per packed RBC unit; OR 0.97 for 0 to 7 days old; OR 1.04 for 8 to 14 days old and OR 1.02 for 15 to 21 days old. Results of sensitivity analyses were similar only among patients who received greater than or equal to 10 packed RBC units. Packed red blood cells aged 22 days or more were associated with a 5% increase in mortality risk As more units of packed red blood cells were transfused, the likelihood of harm increased, the study found. The authors concluded that increasing quantities of older packed RBCs are associated with increased likelihood of 24-hour mortality in trauma patients receiving massive packed RBC transfusions (≥10 units), but not in those who receive fewer than 10 units. Allison R. Jones, PhD, RN, CCNS, an Assistant Professor and lead author of the study said, “Our analysis shows that transfusions of packed red blood cell units stored for 22 days or longer are potentially toxic. To avoid adverse events or death, patients who require massive transfusions may benefit from receiving fresh stored packed red blood cells, or those stored for 14 days or less.” The study was published on November 14, 2018, in the journal Annals of Emergency Medicine. Image: Major trauma victims who receive transfusions of packed blood 22 days old or older may face increased risk of death within 24 hours (Photo courtesy of South West London Pathology).

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Tau Blood Test for Alzheimer’s Disease cont’d from cover

The tau protein has long been implicated in Alzheimer’s; however, tau occurs as a family of related molecules, which have subtly different properties. Scientists have taken advantage of the complexity of tau and built assays to measure different forms of tau and identified a subset of tau proteins, which are specifically elevated in Alzheimer’s disease. A team of scientists working with those at Brigham and Women’s Hospital (Boston, MA, USA; www.brighamandwomens.org) developed a set of immunoassays to measure tau in specimens from humans diagnosed based on current best clinical and cerebrospinal fluid (CSF) biomarker criteria. The developed tests were capable of detecting different populations of tau fragments in cerebrospinal fluid and blood. They applied these tests to participants who had been recruited to the Harvard Aging Brain Study as well as participants seen at the Institute of Neurology in London. Each participant donated both plasma and cerebrospinal fluid. They validated the results in a second group of patients that had been recruited. The team analyzed five different tests for tau fragments, finding that one, known as the N-terminal (NT1) assay, showed sufficient diagnostic sensitivity (the ability to predict AD cases) and specificity (the ability to exclude controls) to pursue its use as a potential screening tool for Alzheimer’s disease. This was confirmed in both sets of patients. In CSF, mid-region- and N-terminal-detected tau predominated and rose in disease. In plasma, an NT1 assay detected elevated levels of tau in AD and AD-mild cognitive impairment (MCI). Plasma NT1 measurements separated controls from AD-MCI and AD in a discovery cohort and in a validation cohort. While performing the studies, twice, in two sets of patients with two different demographic backgrounds, provided important confirmation, the authors noted that both groups of participants were small (65 participants and 86 participants, respectively). The authors concluded that the forms of tau in CSF and plasma are distinct, but in each specimen type, the levels of certain fragments are increased in AD. Measurement of plasma NT1 tau should be aggressively pursued as a potential blood-based screening test for AD/AD-MCI. Dominic M. Walsh, PhD, a Lecturer on Neurology and corresponding author of study said, “A blood test for Alzheimer’s disease could be administered easily and repeatedly, with patients going to their primary care office rather than having to go into a hospital. Ultimately, a blood-based test could replace cerebrospinal fluid testing and/or brain imaging. Our new test has the potential to do just that. Our test will need further validation in many more people, but if it performs as in the initial two cohorts, it would be a transformative break-

LabMedica International April/2019

through.” The study was published on November 9, 2018, in the journal Alzheimer’s & Dementia. Image: A section from the hippocampus of an Alzheimer’s disease patient stained with a tau antibody (TNT1). Note the classical triad of tau pathologies in AD, 1) neurofibrillary tangles (arrowheads), 2) neuropil threads (arrows), and 3) a neuritic plaque (asterisk) (Photo courtesy of Michigan State University).

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Advanced System Brings Integrated Solution to Clinical Flow Cytometry ntroduced by Beckman Coulter (Brea, CA, USA; www.beckmancoulter. com), the ClearLLab 10C System for clinical flow cytometry labs includes the first 10-color CE-IVD panels of immunophenotyping reagents for both lymphoid and myeloid lineages. The system's four ClearLLab 10C panels are designed specifically to run on Beckman's Navios and Navios EX flow cytometers, with new, advanced Navios compensation setup software. Alongside the panels, the integrated ClearLLab 10C system comprises ClearLLab Control Cells – a liquid preparation of stabilized human erythrocytes and leukocytes (lymphocytes monocytes and granulocytes) – the first application-specific IVD control cells for L&L immunophenotyping as part of a validated system. ClearLLab Control Cells include assay values for the 27 markers currently available on the four ClearLLab10C panels, available for both normal and abnormal controls. The system also comprises New ClearLLab Compensation Beads for establishing compensation using the ClearLLab compensation kit, which includes 10 single color tubes for each compensation setup. The tubes utilize DURA Innovations dry reagent technology for the panels, which requires no refrigeration and help deliver high-quality results from dry

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unitized combinations of CD (cluster of differentiation) markers. These pre-formulated antibody combinations help labs to avoid the potential errors of manual antibody cocktail preparation. The ClearLLab 10C System incorporates the company’s new Kaluza C software to streamline and standardize clinical QC reporting to international guidelines. When using the ClearLLab 10C system, compensation is only required on initial set-up of the application, when daily QC fails, after instrument service as needed, or when switching to a new lot of Flow-Set Pro. With the ClearLLab 10C System, laboratories now have a portfolio of flow cytometric tools - enabling them to provide accurate patient results for L&L analysis in a compliant lab setting, without needing to carry out extensive manual validation, preparation and QC tasks. ClearLLab 10C is also supported by a training resource, the ClearLLab 10C case book, which provides 24 diagnostic vignettes giving characteristic findings after flow cytometric analysis, with expert assessment by hematopathologists. Labs can also compare the interpretation of their own findings with the analysis in the casebook. With the ClearLLab 10C System, workflow is reduced to four straightforward, standardized steps – sample processing, sample acquisition, reporting and validation. The reagents can be used with peripheral whole blood (collected in K2EDTA, Acid Citrate Dextrose (ACD) or Heparin), bone marrow (collected in K2EDTA, Acid Citrate Dextrose (ACD) or Heparin) and lymph node specimens. “The ClearLLab 10C System is an integrated solution, offering labs standardized workflow that delivers greater confidence in the consistency and reliability of their clinical findings. Further, it reduces the timeconsuming, error-prone pipetting steps of lab-developed tests, replacing them with a more time-efficient alternative that also simplifies clinical QC reporting,” said Dr. Mario Koksch, Vice President of Cytometry at Beckman Coulter.

Newborn Genomic Sequencing Detects Disease Risk Factors cont’d from cover

range of disorders in babies who are asymptomatic at birth and thereby expand the spectrum of conditions for which screening is possible. A team of scientists collaborating with the Brigham and Women’s Hospital (Boston, MA, USA; www.brighamandwomens.org) enrolled 128 healthy newborns from a well-baby nursery and 31 ill newborns from the hospital’s neonatal and pediatric intensive care units. Family histories were collected for all enrolled participants. Half of the families from each group were randomized to receive standard care, including “heel prick” newborn screening which tests for about 30 genetic conditions, and genetic counseling based on family history; the other half received whole exome sequencing in addition to standard care and genetic counseling. The team reported that 15 (9.4%) were found to have a genetic variant for which there was strong evidence of increased risk of a disorder that presents or is clinically manageable during childhood, or a variant in a gene for which there was moderate evidence of risk but for which an intervention during childhood might prevent devastating outcomes later in life. The team found variants associated with several heart conditions, including six newborns with variants associated with dilated or hypertrophic cardiomyopathy and another newborn with a variant associated with supravalvular aortic stenosis. These conditions can be monitored over time, and families have been referred to cardiac specialists. Another newborn was found to have a risk variant for biotinidase deficiency. Further testing determined that the infant had partial biotinidase deficiency, a condition that can cause skin rash, hair loss and seizures. The child’s diet is now being supplemented with biotin, which is expected to prevent any disease manifestations. The study was published on January 3, 2019, in the journal American Journal of Human Genetics. LabMedica International April/2019

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Test Identifies More Treatable Cancer Mutations Than Biopsies tandard of care therapies that target specific mutations have changed the face of cancer treatment, and screening for such mutations, which can be drivers of both disease growth and treatment resistance. This can often be done with a biopsy of tumor tissue, but sometimes that tissue is hard to obtain or does not have sufficient DNA for analysis. As mutations may change over the course of treatment, meaning patients are sometimes subjected to multiple invasive biopsies. Instead, liquid biopsies use circulating tumor DNA (ctDNA), shed by tumors and circulating in the blood, to test for mutations using next-generation sequencing (NGS). Since ctDNA can be obtained through a simple blood test this ultimately gives patients more therapeutic options and helps them avoid the discomfort and inconvenience of an invasive biopsy procedure. A team of scientists working with the Abramson Cancer Center of the University of Pennsylvania (Philadelphia, PA, USA; www. pennmedicine.org) conducted a single-center prospective study from April 1, 2016, through January 2, 2018. Eligible patients had histologically confirmed stage IV non–small cell lung cancer (NSCLC), and plasma NGS was performed as part of routine clinical testing at diagnosis or

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at disease progression. The study included 323 patients treated, 113 (35%) of who were determined to have targetable mutations. Plasma was analyzed by Guardant Health (Redwood City, CA, USA; https://guardanthealth.com) and during the study, the Guardant 360 panel expanded from 70 genes for116 patients to 73 genes for 207 patients. Clinically relevant mutations included therapeutically targetable driver and resistance mutations in EGFR, ALK, MET, BRCA1, ROS1, RET, ERBB2, and BRAF. KRAS mutations were also included because these are generally mutually exclusive with other targetable variants and obviate further consideration of targeted therapy. A median of three mutations (range, 0-14) was detected per patient in plasma; however, no patient had more than one therapeutically targetable mutation detected. The scientists reported that among the 323 patients with NSCLC (60.1% female; median age, 65 years [range, 33-93 years]), therapeutically targetable mutations were detected in EGFR, ALK, MET, BRCA1, ROS1, RET, ERBB2, or BRAF for 113 (35.0%) overall. Ninety-four patients (29.1%) had plasma testing only at the discretion of the treating physician or patient preference. Among the 94 patients with plasma testing alone, 31 (33.0%) had a therapeutically targetable mutation detected, thus obviating the need for an invasive biopsy. Among the remaining 229 patients who had concurrent plasma and tissue NGS or were unable to have tissue NGS, a therapeutically targetable mutation was detected in tissue alone for 47 patients (20.5%), whereas the addition of plasma testing increased this number to 82 (35.8%). Charu Aggarwal, MD, MPH, an assistant professor of Hematology-Oncology and co-lead author of the study, said, “These findings show that liquid biopsy is increasing the detection of mutations we can target and improving patient outcomes, and when you combine that with the reality that liquid biopsy is less invasive for patients and, in some cases, may be the only option for patients, the clinical impact is very clear.” The study was published on October 11, 2018, in the journal JAMA Oncology. Image: The Guardant360 gene panel is a technology capable of isolating circulating tumor DNA in blood to identify genomic alterations in tumor genomic panel. This test allows identify genomic alterations and match them to treatment options (Photo courtesy of Guardant Health).

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New Automated Assay Measures Levels of sPLA2-llA hospholipase A2 (PLA2s) are a family of enzymes that cleave the fatty acid in position two of phospholipids, hydrolyzing the bond between the second fatty acid “tail” and the glycerol molecule. Of particular interest is the secreted phospholipase (sPLA2-IIA) that specifically recognizes the sn-2 acyl bond of phospholipids and catalytically hydrolyzes the bond, releasing arachidonic acid and lysophosphatidic acid. Upon downstream modification by cyclooxygenases, arachidonic acid is modified into active eicosanoid compounds, including prostaglandins and leukotrienes. sPLA2-IIA has been shown to promote inflammation in mammals by catalyzing the first step of the arachidonic acid pathway by breaking down phospholipids, resulting in the formation of fatty acids including arachidonic acid. This arachidonic acid is then metabolized to form several inflammatory and thrombogenic molecules. Elevated levels of sPLA2-IIA are thought to contribute to several inflammatory diseases, and have been shown to promote vascular inflammation correlating with disease risk in coronary artery disease and acute coronary syndrome. Unlike traditional cardiac biomarkers used to predict adverse outcomes in patients, sPLA2-IIA has been shown to act at multiple pathways involved in atherogenesis, from lipid oxidation to modulation of vascular inflammatory cell activation and apoptosis. Measurement of sPLA2-IIA enables clinicians to gain a comprehensive overview of cardiac risk and may help to tailor treatment accordingly. Recognizing the link between the secreted phospholipases and coronary disease risk, Randox (Crumlin, United Kingdom; www.randox.com) has introduced an automated assay (currently for research use only) to measure levels of sPLA2-IIA. This automated assay eliminates the inconvenient and time consuming traditional ELISA based test for sPLA2-llA. The Randox sPLA2-IIA Assay was designed for use on a wide range of clinical chemistry analysers, and applications are available detailing instrument-specific settings. The latex enhanced immunoturbidimetric assay kit contains liquid ready-to-use reagents INTERACTIVE for convenience and ease-of-use. In adDIGITAL EDITION dition, controls and calibrators are available offering a complete testing package. The addition of the sPLA2-IIA Assay compliments the existing cardiac risk panel from Randox, providing a different outlook and method of assessing cardiac concerns in patients.

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Image: The diagram shows how sPLA2-llA binding to anionic phospholipids leads to its activation and promotes inflammation. The oxidation of the phospholipids produces stress, which causes the anionic phospholipids phosphatidylserine (PS) and phosphatidylethanolamine (PE) to be transported to the outer leaflet. This reaction activates cationic sPLA2-llA. The higher activity of sPLA2-llA promotes the hydrolysis of the outer leaflet phospholipids into arachidonic acid and lysophospholipids. Through the cyclooxygenase and 5-lipoxygenase enzymes, arachidonic acid is converted into prostaglandins, leukotrienes, and other inflammatory eicosanoids (Photo courtesy of Randox).

LabMedica International April/2019

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PRODUCT NEWS CHEMISTRY ANALYZER

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DIAGNOSTIC ASSAY

RAPID TEST

Erba Mannheim

DiaSorin

NG Biotech

The XL 640 is a completely automated, small footprint floor-standing clinical chemistry analyzer. The system can achieve a total throughput of up to 640 tests/hour (400 photometric + 240 ISE [Na/K/Cl/Li]).

The Simplexa VZV Direct assay enables the direct detection of varicella-zoster virus DNA from CSF. It was designed for use on the LIAISON MDX instrument for use with patients with suspected CNS infections.

The NG-Test Blood Precision hCG fully-integrated blood-based rapid test is for the detection of hCG levels in pregnancy using an innovative lateral flow platform. It delivers highly accurate results in just five minutes.

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Fatal Prostate Cancer Differentiated from Manageable Cancer uman prostate cancers display numerous DNA methylation changes compared to normal tissue samples. However, definitive identification of features related to the cells’ malignant status has been compromised by the predominance of cells with luminal features in prostate cancers. A recent study showed that more than 25 men were being unnecessarily treated with surgery or radiotherapy, for every single life saved. It is believed that success rates could be hindered as a result of treating all prostate cancers in the same way. A test has been designed that can pick out life-threatening prostate cancers, with up to 92% accuracy. Scientists at the University of York (York, UK; www.york.ac.uk) and the University of British Columbia (Vancouver, BC, Canada: www. ubc.ca) generated genome-wide DNA methylation profiles of cell subpopulations with basal or luminal features isolated from matched prostate cancer and normal tissue samples. The team analyzed more than 500 cancer tissue samples and compared them with non-cancer tissue to search for patterns of a chemical group that is added to part of the DNA molecule, altering gene expression. The team reported that many frequent DNA methylation changes previously attributed to prostate cancers were identified as differences between luminal and basal cells in both normal and cancer samples. They also identified changes unique to each of the two cancer subpopulations. Those specific to cancer luminal cells were associated with regulation of metabolic processes, cell proliferation and epithelial development. Within the prostate cancer TCGA dataset, these changes were able to distinguish not only cancers from normal samples, but also organ-confined cancers from those with extraprostatic extensions. Using changes present in both basal and luminal cancer cells, they derived a new 17-CpG prostate cancer signature with high predictive power in the TCGA dataset. Davide Pellacani, PhD, the lead senior author of the study, said, “Us-

ing this computer analysis, not only could we see which tissue samples had cancer and which didn’t, but also which cancers were dangerous and which ones less so. Out of almost a million markers studied, we were able to use our new tools to single out differences in cancer potency.” The study was published on October 15, 2018, in the journal British Journal of Cancer. Image: A photomicrograph from a prostate biopsy of prostatic adenocarcinoma, conventional (acinar) type, the most common form of prostate cancer (Photo courtesy of Nephron).

New Techniques Can Detect Lyme Disease Earlier yme disease, also known as Lyme borreliosis, is an infectious disease caused by Borrelia bacteria, spread by ticks. The most common sign of infection is an expanding area of redness on the skin, known as erythema migrans, that appears at the site of the tick bite about a week after it occurred. Lyme disease is the most common tick-borne infection in North America and Europe. There are currently over 300,000 cases of Lyme disease annually in the USA alone, and the disease is increasing and spreading into new regions. New techniques have been developed that can detect an active infection with the Lyme bacteria faster than the three weeks it takes for the current indirect antibody-based tests.

A team of scientists led by those at Rutgers New Jersey Medical School (Newark, NJ, USA; www.njms.rutgers.edu) developed new techniques that can detect an active infection with the Lyme bacteria faster than the three weeks it takes for the current indirect antibody-based tests that were developed more than two decades ago. Another advantage of the new tests is that a positive result in blood indicates the infection is active and should be treated immediately, allowing quicker treatment to prevent long-term health problems. The techniques detect DNA or protein from the Lyme disease bacteria Borrelia burgdorferi. The study was published on October 11, 2018, in the journal Clinical Infectious Diseases. LabMedica International April/2019

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PRODUCT NEWS IMMUNOASSAY SYSTEM

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PROTEIN ANALYZER

CHEMISTRY ANALYZER

Chemclin Diagnostics

Goldsite Diagnostics

Genrui Biotech

The LiCA Smart offers a throughput of 180 tests/hour and features a load-up capacity of 100 samples with 24 reagent positions. It requires no washing and separation steps, and offers first results for cardiac panel in 12 minutes.

The GPP-100 uses an all-in-one cartridge for a single test and allows for auto ID of assays by barcode. Other features include a wide test menu, maintenance-free operations, and color touch screen.

The GS300 Plus features a throughput up to 240 tests per hour, 81 plastic cuvettes, 60 reagent positions and 60 sample positions. Key features include 24-hour non-stop cooling and stable heating for reaction.

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Rapid Test for Sickle-Cell Disease Evaluated ickle cell disease (SCD) is a common, life threatening genetic disorder that is best managed when diagnosed early by newborn screening. Sickle cell disease (SCD) is highly prevalent in sub-Saharan Africa and central India. Sickle cell anemia is the most common and severe form of SCD. In sub-Saharan Africa, where up to 90% of children with SCD are thought to die undiagnosed before the age of five, screening tests in newborns have not been implemented universally. Early diagnosis and prevention can avert 70% of the deaths that occur in these regions due to SCD. However, the available diagnostic tests are costly, and cumbersome, and may take weeks or even months to inform the family of the diagnosis. Therefore, a point-of-care diagnostic tool for SCD is an urgent need. An international team of hematologists collaborating with the Cincinnati Children’s Hospital Medical Center (Cincinnati, OH, USA; www.cchmc.org) included in their study 383 participants from Ghana, 46 from Martinique and 158 from the USA. The age range of the participants was newborn to 30 years; 16.6% of the participants from Ghana and Martinique were under one-month-old. Ghana also has a high prevalence HbS and HbC sub-types. In this global, multi-center study, patient blood was tested using HemoType SC kits (Azusa, CA, USA; https://hemotype.com) at the site of sample collection. The diagnostic accuracy of HemoTypeSC, a point of care immunoassay, for SCD was evaluated in individuals who had SCD, hemoglobin C disease, the related carrier (trait) states, or a normal hemoglobin phenotype. The accuracy of the result was compared with the evaluation done in a laboratory in order to validate the

use of HemoType SC as a diagnostic tool to be used where sample collection is performed. The authors concluded that HemoTypeSC is an inexpensive, accurate, and rapid point-of-care test that can be used in resource-limited regions with a high prevalence of sickle cell disease to provide timely diagnosis and support newborn screening programs. The study was first published on October 5, 2018, in the American Journal of Hematology. Image: A photomicrograph of sickle cells in human blood: both normal red blood cells and sickle-shaped cells are present (Photo courtesy of Dr. Graham Beards).

Novel Fecal Biomarker Found for Colorectal Cancer olorectal cancer (CRC) is a lethal disease that has been rising in incidence during recent decades, placing an increasingly important burden on the healthcare system worldwide and gut microbial dysbiosis contributes to the development of this deadly disease. Conventionally, “beneficial” Lactobacillus (Lb) and Bifidobacterium (Bb) have been employed as probiotics in humans, having displayed anti-carcinogenic effects in animal models. Faecalibacterium prausnitzii (Fp), the sole known species of Faecalibacterium, is an anti-inflammatory commensal anaerobe. Scientists at the Sun Yat-sen University (Guangzhou, China; www.sysu.edu.cn) and their colleagues measured the relative abundance of Fusobacterium nucleatum (Fn), Faecalibacterium prausnitzii (Fp), Bifidobacterium (Bb), and Lactobacillus (Lb) by quantitative polymerase chain reaction (PCR) in fecal samples from two cohorts of 903 individuals. They evaluated and validated the diagnostic performance of these microbial ratios and investigated the antagonistic

effect of Fn against three different indicator stains. The quantification of the microbiomes’ target and reference gene (universal 16S rDNA) was performed in triplicate on a LightCycler 480 II (Roche Applied Science, Penzberg, Germany; www.lifescience. roche.com) using an SYBR Green-based assay (Bio-Rad, Hercules, CA, USA; www.bio-rad.com). The minimum inhibitory concentration (MIC) of the cell-free culture supernatants (CFSs) was determined according to the standard broth microdilution method. Flow cytometric measurements were performed on a flow cytometer (Merck, Burlington, MA, USA; www.merckmillipore.com). The authors concluded that Fn could play a role in microbiota dysbiosis via the secreted antagonistic substances against probiotics. Moreover, the ratio of Fn to the important probiotics Fp and Bb was identified as a valuable biomarker for screening early CRC. The study was published in the September 2018 issue of the journal Clinical Chemistry. LabMedica International April/2019

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PRODUCT NEWS IMMUNOASSAY ANALYZER

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ESR READER

HEMATOLOGY ANALYZER

Shenzhen YHLO Biotech

Greiner Bio-One

Erba Mannheim

The iFlash 1800 offers a throughput of 180 tests per hour. With 50 sample positions, 20 refrigerated reagent positions and random reaction vessel loading design, it is suitable for different lab needs.

The ESR Reader offers a tube throughput of 40 samples per hour after 15 minutes and 20 samples per hour after 30 minutes. It comes with various features such as auto test function and a port for an external printer.

The H 560 5-part differential analyzer can run up to 60 samples/hour and requires only 15 microliters of blood. Interpretation of results is aided by an advanced 3D scattergram, improving lab efficiency.

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Kidney Disease Biomarker May Indicate Lung Problems hronic lower respiratory diseases (CLRD) are the fourth leading cause-of-death and a major source of health care costs. CLRD includes chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, and asthma, airflow limitation as a physiologic correlate, and acute exacerbations as the major clinical manifestation. Albuminuria is a commonly used biomarker of endothelial damage in the kidneys and correlates with microvascular dysfunction throughout the body, including in the pulmonary circulation. Cross-sectional studies suggest albuminuria is increased in COPD patients, among whom it is adversely associated with lung function, gas exchange, and hypoxia. A large team of scientists working with the Columbia University College of Physicians & Surgeons (New York, NY, USA; www.ps. columbia.edu) conducted their study by pooling information from 31,877 participants (average age: 60 years) from six cohort studies. Urine albumin was measured by nephelometry or immunoturbidometry, and urine creatinine assessed by the Jaffe method. These were used to calculate the spot urine albumin-to-creatinine ratio, called â&#x20AC;&#x153;albuminuria.â&#x20AC;? Pre-bronchodilator lung function was measured using water-seal, dry-rolling-seal, or flow sensing spirometers. Incident moderate-to-severe COPD was defined as FEV1/FVC<LLN and FEV1<80% at the final spirometry exam. The team reported that they found for each standard deviation increase in albuminuria, there was a 15% increase in those who devel-

oped moderate-to-severe COPD; a 26% increase in COPD hospitalizations and deaths; and 3% greater decline in FEV1 (the amount of air that can be forcibly exhaled in one second) and an 11% greater decline in the ratio between FEV1 and FVC (the total amount of air that can be forcibly exhaled after taking the deepest breath possible). Both FEV1 and FEV1/FVC are important measures of lung function. The study was published on September 28, 2018, in the American Journal of Respiratory and Critical Care Medicine. Image: An albumin immunoturbidimetric assay urine or serum plasma; standard microalbumin range is 0.4-500mg/L (Photo courtesy of Sentinel Diagnostics).

Blood Test Identifies Heart Failure with Preserved Ejection Fraction test based on a protein biomarker found in the blood is the basis of a scoring system that distinguishes patients with clinical heart failure with preserved ejection fraction (HFpEF) from healthy individuals and patients with risk factors but no heart failure. Heart failure with preserved ejection fraction is a growing epidemic worldwide with a high burden of morbidity and mortality. Lack of understanding of the pathology and physiology of the syndrome has limited development of diagnostic tools to define and follow the disease progression. Cardiac bridging integrator 1 (cBIN1) is a membrane-scaffolding protein in cardiomyocytes that organizes the dyad-containing microdomains at the transverse tubules that are responsible for the initiation and regulation of systolic and diastolic calcium transients. The level of cBIN1 is reduced in animal models of heart failure, as well as in human biopsy samples from patients with end-stage cardiomyopathy. Its blood availability makes it an attractive biomarker of cardiomyocyte remodeling.

Investigators at Cedars-Sinai Medical Center (Los Angeles, CA, USA; www.csmc.edu) determined cBIN1 scores (CS) from ELISA measurement of plasma cBIN1 concentrations from 52 stable, ambulatory patients with HFpEF from age-matched and sex-matched healthy individuals and participants with heart failure risk factors but no HFpEF. The analysis examined the ability of the CS and N-terminal pro-B-type natriuretic peptide (NT-proBNP) results to differentiate among the patients. Results revealed that the CS values were significantly higher in the patients with HFpEF than in the two control cohorts. For patients with HFpEF, the CS outperformed NT-proBNP when the comparator group was either healthy control participants or those with risk factors. Thus, the plasma CS, a marker of transverse tubule dysfunction, serves as a biomarker of cardiomyocyte remodeling that has the potential to aide in the diagnosis of HFpEF. The study was published in the October 31, 2018, online edition of the journal JAMA Cardiology. LabMedica International April/2019

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PRODUCT NEWS ELISA IMMUNOASSAYS

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ELISA ANALYZER

ESR ANALYZER

Mast Group

Shenzhen YHLO Biotech

ELITech Group

The EIA immunoassays are designed for the detection of antibodies against bacterial, fungal and protozoan agents of infectious disease. The antigens are pre-coated onto 96-well plates in break-apart format.

The UNION instrument is designed to carry out in vitro diagnostic tests. All reagents needed are in a single readyto-use strip and up to 30 different assays can be performed simultaneously in one cycle.

The MICROsed-System offers an ESR solution for smaller-sized labs that require walkaway capability. It offers 10 channels, throughput of up to 40 tests/hr, and a reading time capability of 15-60 minutes.

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Highly Multiplexed Broad Pathogen Assay Detects Infectious Diseases dentifying the causative agent in an acute febrile illness can be challenging diagnostically, especially when organisms in a particular region have overlapping clinical presentation or when that pathogen’s presence is unexpected. Rapid pathogen identification during an acute febrile illness is a critical first step for providing appropriate clinical care and patient isolation. Primary screening using sensitive and specific assays, such as real-time polymerase chain reaction (RT-PCR) and enzyme-linked immunosorbent assays (ELISAs), can rapidly test for known circulating infectious diseases. Scientists at the United States Army Medical Research Institute of Infectious Diseases (Fort Detrick, MD, USA; www.usamriid.army.mil) developed a highly multiplexed assay designed to detect 164 different viruses, bacteria, and parasites using the NanoString nCounter platform (Seattle, WA, USA; www.nanostring.com). Included in this assay were high consequence pathogens such as Ebola virus, highly endemic organisms including several Plasmodium species, and a large number of less prevalent pathogens to ensure a broad coverage of potential human pathogens. The team used the Broad Pathogen Detection Assay (BPDA) for use with the NanoString nCounter platform in order to quickly screen a sample for multiple pathogens in a single tube reaction. Mock clinical samples were prepared in order to evaluate the ability of the BPDA to detect samples that had been extracted from whole human blood. Eval-

uation of the panel resulted in positive detection of 113 (encompassing 98 different human pathogen types) of the 126 organisms available to us including the medically important Ebola virus, Lassa virus, dengue virus serotypes 1–4, Chikungunya virus, yellow fever virus, and Plasmodium falciparum. The authors concluded that the hands on time and sample volume requirement are minimal for the BPDA. The assay performed well in mock clinical and human clinical samples, demonstrating the clinical utility of this assay in cases where the initial diagnostic testing results in negative results. Overall, this assay could improve infectious disease diagnostics and biosurveillance efforts as a quick, highly multiplexed, and easy to use pathogen-screening tool. The study was published on November 5, 2018, in the journal Public Library of Science Neglected Tropical Diseases. Image: The nCounter platform provides a simple and cost effective solution for multiplex analysis of up to 800 RNA, DNA, or protein targets from diverse samples (Photo courtesy of NanoString).

Urine Biopsies Help Monitor Bladder Cancer Treatment espite the advances in cancer immunotherapy, only a fraction of patients with bladder cancer exhibit responses to checkpoint blockade, highlighting a need to better understand drug resistance and identify rational immunotherapy combinations. In patients with bladder cancer, the urine is a rich source of tumor-derived material that could potentially serve as a window to bladder tumor immune microenvironment. Several groups have investigated the use of urinary-based biomarkers for the detection of bladder cancer, but their clinical use remains limited by the sensitivity and specificity of the assays used. A large team of scientists collaborating with the University College London (London, UK; www.ucl.ac.uk) collected matched bladder tumor, non-tumor (NT) tissue urothelium, urine, and peripheral blood mononuclear cell (PBMCs) from 32 patients undergoing radical cystec-

tomy. The patient cohort comprised of those initially diagnosed with muscle invasive bladder cancer (MIBC). The cohort included 13 patients that were either treatment naïve or 19 that had received prior therapy (chemotherapy, immunotherapy, or Bacillus Calmette-Guerin) during the six months preceding cystectomy. All urine samples were tested by dipstick for the presence of infection. Any sample that tested positive for nitrites was excluded from further analyses. PBMC and urine-derived lymphocytes (UDLs) were isolated through density-gradient centrifugation. Live cells were stained fresh following isolation. Flow cytometry was performed using antibodies and fluorescent labels for analysis on the BD LSR II Fortessa (BD Biosciences, Franklin Lakes, NJ, USA; www.bdbiosciences.com). The study was published on September 26, 2018, in the Journal of Experimental Medicine. LabMedica International April/2019

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LabMedica International

Noninvasive Blood Glucose Test Evaluated for Accuracy or those living with diabetes, monitoring blood glucose accurately is necessary to prevent diabetes-related complications such as heart attacks, blindness and coma. Optical monitoring of blood glucose levels for non-invasive diagnosis is growing. Recent efforts in this direction have been inclined towards reducing the requirement of calibration framework. Scientists have evaluated the accuracy of new technology to monitor blood glucose levels without needles or a finger prick. Early results show that the noninvasive technology measures blood glucose levels as effectively as a finger prick test without drawing blood. A team of scientists from the Massachusetts Institute of Technology (Cambridge, MA, USA; www. mit.edu) and the University of Missouri-Columbia (Columbia, MO, USA; https://missouri.edu) measured the blood glucose levels of 20 healthy, non-diabetic adults prior to drinking a glucose-rich beverage. Blood glucose levels were then measured in intervals over the next 160 minutes using three methods: spectroscopy, intra-venous blood test and finger prick. The tests are designed to determine how much glucose remains in the blood and if a patient’s insulin-regulating mechanisms are working effectively. They found that spectroscopy predicted glucose values as accurately as a finger prick test. The device uses a technique called Raman spectroscopy to measure the chemical composition of skin and extract the amount of glucose out of other skin compartments. A fiber optic cable attached to a wristband passes laser light onto the skin to detect different components in the skin, such as fat tissue, protein, collagen and glucose molecules. The shifts in wavelengths associated with glucose present in the blood create a sort of molecular fingerprint that can be used to determine glucose levels. Jeon Woong Kang, PhD, a lead co-author of the study said, “We know that handheld skin prick tests are not always accurate and may be uncomfortable for patients. The gold standard is intravenous blood testing, but frequent blood draws may not be an option for many patients. We were pleased to find that our initial results show Raman spectroscopy can measure glucose levels that are comparable to the finger stick devices. We hope that we can refine this method to be a noninvasive continuous glucose monitoring sensor.” The study was published in the October 2018 issue of the journal Analytical and Bioanalytical Chemistry.

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Image: This device uses laser technology to detect glucose levels under the skin, an alternative to painful pricking (Photo courtesy of University of Missouri-Columbia).

LabMedica International April/2019

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PRODUCT NEWS MYCOPLASMA TEST

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COAGULATION ANALYZER

POC ANALYZER

ELITech Group

HORIBA Medical

Nova Biomedical

The MYCOFAST RevolutioN ATB+ identifies U.u. and M.h. growth after 24 hours of incubation. It provides easy-toread and interpret results, which are read by the color obtained in the different wells.

The Yumizen G800 features a throughput of 100PT tests/hour. Key benefits include four independent channels, 14 cooled + four reagent positions and 10 samples + five STAT sample positions.

The Allegro features 12 measured and selectable tests, plus six calculated tests to assess glycemic control, kidney function and cardiac risks. Accurate results are available during the patient visit.

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DNA Recombination in Brain Linked to Alzheimer’s Disease lzheimer’s disease is a public health crisis. The cause of the disease remains unknown and no meaningful treatment exists. Nearly six million people in the USA are living with Alzheimer’s disease, a number projected to reach 14 million by 2060 as the population ages. The amyloid hypothesis, or the theory that accumulation of a protein called beta-amyloid in the brain causes Alzheimer’s disease, has driven Alzheimer’s studies to date. However, treatments that target beta-amyloid have notoriously failed in clinical trials. A team of scientists associated with the Sanford Burnham Prebys Medical Discovery Institute (La Jolla, CA, USA; www.sbpdiscovery.org) have identified gene recombination in neurons that produces thousands of new gene variants within Alzheimer’s disease brains. The study reveals for the first time how the Alzheimer’s-linked gene, Amyloid Beta Precursor Protein (APP), is recombined by using the same type of enzyme found in human immunodeficiency virus (HIV). The investigators used new analytical methods that focused on single and multiple-cell samples, and found that the APP gene, which produces the toxic beta amyloid proteins defining Alzheimer’s disease, gives rise to novel gene variants in neurons, creating a genomic mosaic. The process required reverse transcription and reinsertion of the variants back into the original genome, producing permanent DNA sequence changes within the cell’s DNA blueprint. All of the Alzheimer’s disease brain samples contained an over-abundance of distinct APP gene variants, compared to samples from normal brains. The team discovered that neurons from the patients with Alzheimer’s disease contained about six times as many varieties of the APP gene as did the cells from the healthy people. Among these

Alzheimer’s-enriched variations, the scientists identified 11 single-nucleotide changes identical to known mutations in familial Alzheimer’s disease, a very rare inherited form of the disorder. Although found in a mosaic pattern, the identical APP variants were observed in the most common form of Alzheimer’s disease, further linking gene recombination in neurons to disease. Jerold Chun, MD, PhD, a professor and senior author of the study said, “These findings may fundamentally change how we understand the brain and Alzheimer’s disease. If we imagine DNA as a language that each cell uses to ‘speak,’ we found that in neurons, just a single word may produce many thousands of new, previously unrecognized words. This is a bit like a secret code embedded within our normal language that is decoded by gene recombination. The secret code is being used in healthy brains but also appears to be disrupted in Alzheimer’s disease.” The study was published on November 21, 2018, in the journal Nature. Image: Gene recombination in neurons that produces thousands of new gene variants within Alzheimer’s disease brains have been identified (Photo courtesy of Sanford Burnham Prebys Medical Discovery Institute).

Routine Vitamin B12 Screening May Prevent Irreversible Nerve Damage he increasing incidence of type-2 diabetes is a serious health issue worldwide. Its prevalence is associated with poor diet and unhealthy lifestyle choices, and it is characterized by high blood glucose levels that need to be controlled by medication. Nerve damage in the periphery (e.g. face, limbs, and organs) is a common complication of diabetes, with symptoms that range from numbness to pain, and can lead to debilitating loss of balance and co-ordination. Metformin is the recommended and most effective first-line drug for type-2 diabetes but its use has also been linked to vitamin B12 deficiency, which increases the risk of peripheral nerve damage. Physicians at the Hucknall Road Medical Centre (Nottingham, UK;

www.hucknallrdmc.co.uk) conducted an audit of vitamin B12 screening and deficiency among female, metformin-treated, patients with type2 diabetes at their practice. The audit findings indicated that 64% of patients had not had their vitamin B12 levels checked at all and that 9.6% of patients were deficient but only 6.4% were being treated with vitamin B12. The study findings suggest that earlier detection of vitamin B12 deficiency through routine screening of all metformin-treated, type2 diabetes patients could reduce their risk of developing irreversible, painful and potentially disabling nerve damage. The study was presented at the Society for Endocrinology annual conference held November 19-21, 2018, in Glasgow, UK. LabMedica International April/2019

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LabMedica International

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Biochemical Hypoglycemia Associated With Risk of Hypoglycemia o optimize diabetes management, it is essential to have assessments of both hyperglycemia and hypoglycemia. Glycated hemoglobin (HbA1c) is primarily a measure of hyperglycemia, but it provides no indication of the frequency or severity of hypoglycemia. However, combining HbA1c with continuous glucose monitoring (CGM) provides not only measures of hypoglycemia and hyperglycemia but also information about the patterns of glycemia over the course of the day. Severe hypoglycemia (SH) may result in a variety of symptoms including clumsiness, trouble talking, confusion, loss of consciousness, seizures or death. A feeling of hunger, sweating, shakiness and weakness may also be present.

Scientists at the Jaeb Center for Health Research (Tampa, FL, USA; www.jaeb.org) and their colleagues, analyzed data collected from Diabetes Control and Complications Trial. Glycemic data used in the analyses included the quarterly 7-point glucose measurements and recorded SH events. The 7-point testing consisted of blood samples collected in capillary tubes pre- and 90 min post meals and at bedtime that were sent to the central laboratory. For each 7-point testing day, the frequency of values <70 and <54 mg/dL was computed. The team found that the risk of SH during a 3-month period was substantially higher when there was at least one hypoglycemic blood glucose value in the preceding 7-point profile, with similar results seen for both the 70 mg/dL (rate ratio = 3.0) and 54 mg/dL (rate ratio = 2.7) thresholds. The risk of an SH event during the 3-month period was more than twofold greater when there was at least one hypoglycemic blood glucose measurement on the 7-point testing, and risk increased further when there was more than one hypoglycemic blood glucose concentration. The authors concluded that the occurrence of biochemical hypoglycemia <70 or <54 mg/dL is associated with an increased risk of SH. For this reason as well as the deleterious effects of hypoglycemia on glucose counter-

regulation and hypoglycemia awareness, cognition, quality of life, and arrhythmias, it is important in diabetes management to avoid hypoglycemic glucose levels as much as possible. Satish Garg, MD, a Professor of Medicine and Pediatrics, said, “Severe hypoglycemia is a significant hurdle for intensifying insulin therapy in patients with T1D. Beck and colleagues emphasize the increased risk of future severe hypoglycemia in patients with any level of biochemical hypoglycemia.” The study was published on January 8, 2019, in the journal Diabetes Technology & Therapeutics. Image: Testing blood glucose regularly allows for glycemic control strategy (Photo courtesy of the American Academy of Family Physicians).

CD69 Biomarker Expression Predicts Atherosclerosis Risk therosclerosis is a disease characterized by the accumulation of lipid deposits in the artery wall, but the disease is usually not detected until after it has caused a clinical event such as a myocardial infarction or stroke. The origin of atherosclerosis and its progression to acute myocardial infarction and stroke involve an essential contribution from the inflammatory immune response. Because of the diminished quality of life experienced by affected individuals, treatment after symptoms appear is of limited benefit, and the long-term management of the disease is a major cost for health care systems. Scientists at the Spanish National Center for Cardiovascular Research (Madrid, Spain; www.cnic.es) and their colleagues evaluated the association between the CD69 receptor, a regulator of Th17/regulatory T cell immunity, and atherosclerosis development in animal models and in patients with subclinical disease. Low-density lipoprotein receptor–deficient chimeric mice expressing or not expressing CD69 on either myeloid or lymphoid cells were subjected to a high fat diet. In vitro functional assays with human T cells were performed to decipher the mechanism of the observed phenotypes. Expression of CD69 and NR4A nuclear receptors was evaluated by reverse transcription–polymerase chain reaction

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in 305 male participants, 128 with extensive or 55 with focal subclinical atherosclerosis and 122 without disease. To assess the immune response, the percentages of IL-17–eGFP+ or Foxp3-RFP+ cells in peripheral blood CD4+ T cells were monitored throughout the study by flow cytometry using a FACSCanto Flow Cytometer (BD Biosciences, San Jose, CA, USA; www.bdbiosciences.com). Expression of NR4A receptors was also assessed in Jurkat T cells and human primary lymphocytes in the presence or not of Oxidized Low-Density Lipoprotein (oxLDL). When indicated, blocking anti-CD69 antibodies were also added. NR4A and CD69 mRNA expression was also determined in para-aortic lymph nodes and peripheral blood lymphocytes from mice. The scientists reported that participants of the study with evidence of subclinical atherosclerosis displayed a significant CD69 and NR4A1 mRNA down regulation in peripheral blood leukocytes (PBLs) compared with participants without disease. The expression of CD69 remained associated with the risk of subclinical atherosclerosis after adjustment for traditional risk factors, the expression of NR4A1, the level of oxidized low-density lipoprotein, and the counts of different leucocyte subsets. The study was published in the January 2019, issue of the journal Circulation. LabMedica International April/2019

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Standalone HPV Testing Recommended for Cervical Cancer Screening he number of deaths from cervical cancer in the USA has decreased substantially since the implementation of widespread cervical cancer screening and has declined from 2.8 to 2.3 deaths per 100,000 women from 2000 to 2015. The evidence on screening for cervical cancer has been reviewed with a focus on clinical trials and cohort studies that evaluated screening with high-risk human papillomavirus (hrHPV) testing alone or hrHPV and cytology together (co-testing) compared with cervical cytology alone. The US Preventive Services Task Force (Rockville, MD, USA; www.uspreventiveservices taskforce.org) besides reviewing and evaluating cervical cancer screening also commissioned a decision analysis model to evaluate the age at which to begin and end screening, the optimal interval for screening, the effectiveness of different screening strategies, and related benefits and harms of different screening strategies. The experts reported on screening with cervical cytology alone, primary hrHPV testing alone, or co-testing can detect high-grade precancerous cervical lesions and cervical cancer. Screening women aged 21 to 65 years substantially reduces cervical cancer incidence and mortality. The harms of screening for cervical cancer in women aged 30 to 65 years are moderate. Four studies identified in the review found that primary hrHPV testing detected higher rates of stage 3 (or worse) cervical intraepithelial neoplasia compared with the standalone Pap test in the first round of testing. In comparing the Pap, hrHPV and co-testing methods, the latter two methods were associated with higher colposcopy and falsepositive rates. The scientists concluded with high certainty that the benefits of screening every three years with cytology alone in women aged 21 to 29 years substantially outweigh the harms. They also concluded with high certainty that the benefits of screening every three years with cytology alone, every five years with hrHPV testing alone, or every five years with both tests (co-testing) in women aged 30 to 65 years outweigh the harms. Screening women older than 65 years who have had adequate prior screening and women younger than 21 years does not provide significant benefit. The anticipation is hrHPV testing every five years for women aged 30 to 65 could reduce cervical cancer mortality from 8.34 to 0.29 deaths per 1,000 women. The study was published on August 21, 2018, in the Journal of the American Medical Association.

Image: A photomicrograph of koilocyte cell criteria of Human Papilloma virus (HPV) infection in a Pap smear (Photo courtesy of iStock).

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LabMedica International

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POC Diagnostic Differentiates Ebola from Endemic Febrile Diseases emorrhagic fever outbreaks such as Ebola are difficult to detect and control because of the lack of low-cost, easily deployable diagnostics and because initial clinical symptoms mimic other endemic diseases such as malaria. Current molecular diagnostic methods such as polymerase chain reaction (PCR) require trained personnel and laboratory infrastructure, hindering diagnostics at the point of need. Although rapid tests such as lateral flow can be broadly deployed, they are typically not well suited for differentiating among multiple diseases presenting with similar symptoms. An international team of scientists cooperating with the Becton, Dickinson and Company (Research Triangle Park, NC, USA; www.bd.com) developed a portable test for Ebola designed for use in remote settings. The platform, which is based on a protein detection technology known as Surface-enhanced Raman spectroscopy (SERS), works by adding a small sample of blood to pre-packaged vials containing dried, temperature-stable chemicals. The vial is mixed for 30 minutes before being transferred to a reader that detects light signals associated with viral particles. The reader then delivers results on whether the patient is infected with Ebola, Lassa or malaria in 30 seconds. After successfully testing their device in monkey models of Ebola, the

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team conducted field tests in Senegal and Guinea using 190 blood samples from Ebola patients that were gathered during the 2014 outbreak, 163 samples from malaria patients and 233 samples from non-infected individuals. The test correctly detected the presence of Ebola in 90% of the Ebola samples, compared to a detection rates ranging from 65% to 92% for other rapid diagnostic tests and a rate of 95.7% associated with a standard RT-PCR diagnostic. It also showed excellent capabilities for detecting malaria, detecting infections in 100% of the malaria samples. These results, along with corresponding live virus and nonhuman primate testing of an Ebola, Lassa, and malaria 3-plex assay, indicate the potential of the SERS technology as an important tool for outbreak detection and clinical triage in low-resource settings. John H. Connor, PhD, an associate professor of microbiology and senior author of the study, said, â&#x20AC;&#x153;One challenge in diagnosing Ebola and other infectious diseases with similar symptoms is the lack of an easy test to identify people with these conditions that can be used in the field. In this first feasibility study, our method showed good performance compared to existing laboratory tests for Ebola. If fully developed and commercialized, it could be more portable and less expensive than existing RT-PCR assays.â&#x20AC;? The study was published on December 12, 2018, in the journal Science Translational Medicine. Image: Digitally colorized scanning electron microscopic (SEM) image depicts numerous filamentous Ebola virus particles (red) budding from a chronically infected VERO E6 cell (blue). New technology can distinguish Ebola infected patients from other endemic febrile diseases (Photo courtesy of National Institute of Allergy and Infectious Diseases).

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LabMedica International April/2019

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LabMedica International

Pregnancy-Related Immune Changes Revealed by Placenta Sequencing team of scientists has used single-cell RNA sequencing to map expression profiles in the placenta, focusing on the decidua tissue that forms from the lining of the uterus and placental trophoblast tissue from the fetus that interacts with maternal cells. Trophoblast–decidual interactions underlie common diseases of pregnancy, including preeclampsia and stillbirth. Pre-eclampsia (PE) is a disorder of pregnancy characterized by the onset of high blood pressure and often a significant amount of protein in the urine. When it arises, the condition begins after 20 weeks of pregnancy. A large team of scientists working with the Wellcome Sanger Institute (Cambridge, UK; www.sanger.ac.uk) teased out placental cell interactions and interactions at the interface of maternal and fetal tissues using microscopy

and transcriptomes generated for roughly 70,000 individual cells from first trimester samples, including 11 decidua samples and five placentas, and half a dozen matched normal blood samples. The team also used a statistical approach to interpret communication between cells profiled with a 10x Genomics Chromium droplet system (Pleasanton, CA, USA; www.10xgenomics.com), Illumina sequencing (San Diego, CA, USA; www.illumina. com), and the Smart-seq2 protocol, and developed an open repository to bring the data together, trace cell-specific expression, and predict molecular interactions between different cell types. The team found that their results, revealed ways in which pregnancy reshapes maternal immune activity in the developing placenta, leading to changes in both innate and adaptive

arms of the immune system at sites that might otherwise interfere with the placenta or the uterus, an anti-inflammatory and anti-immune environment that shares some features with tissues surrounding some tumors. The study was published on November 14, 2018, in the journal Nature. Image: The Chromium Single-Cell Gene Expression Solution provides high-throughput, single cell expression measurements that enable discovery of gene expression dynamics and molecular profiling of individual cell types (Photo courtesy of 10X Genomics).

New Gene Variants Associated With Chronic Back Pain ack pain causes more years lived with disability than any other health condition worldwide. Although most adults experience a new (‘acute’) episode of back pain at some point in their lives, the societal burden of back pain is driven by the minority of individuals who fail to recover from such episodes and go on to develop persistent (‘chronic’) back pain (CBP). Back pain is moderately heritable and heritability is greater for chronic than for acute back pain. Although CBP is often attributed to anatomic changes such as intervertebral disc degeneration or disc herniation, such findings have only weak association with CBP. A larger international team of scientists led by the Seattle Epidemiologic Research and Information Center (Seattle, WA, USA; www. seattle.eric.research.va.gov) conducted a genome-wide association study in 158,000 adults of European ancestry, including over 29,000 individuals with chronic back pain, looking for gene variants that were associated with the presence of back pain. Genotyping was performed using commercially available genome-wide arrays. Imputation of single nucleotide polymorphisms (SNPs) and insertions/deletions (indels) was

LabMedica International April/2019

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performed using reference panels from 1000 Genomes phase 1 version 3 or phase 3, or the Haplotype Reference Consortium. The authors concluded that their study identified three novel associations with CBP for loci at SOX5, CCDC26/GSDMC, and DCC Netrin 1 Receptor (DCC). Analysis of data from other GWAS and functional genomics studies suggest possible pleiotropic effects of these loci on other traits including cartilage, osteoarthritis, lumbar disc degeneration, depression, and height/vertebral development, and possible causal effects on CBP mediated through height. Pradeep Suri, MD, MSc, the lead author of the study, said, “The results of our genome-wide association study point to multiple pathways that may influence risk for chronic back pain. Chronic back pain is linked to changes in mood, and the role of the central nervous system in the transition from acute to chronic back pain is well recognized. However, the top two genetic variants we identified suggest causes implicating the peripheral structures, such as the spine.” The study was published on September 27, 2018, in the journal PLOS Genetics.

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Microsatellite Instability Assay Validated For Cancer Studies icrosatellite instability (MSI) occurs when mismatch repair proteins (MMR) fail to fix a DNA replication error, leading to frame-shift mutations in a personâ&#x20AC;&#x2122;s genetic code and non-functioning proteins. MSI has acted as a strong marker for genetic conditions such as Lynch syndrome that can lead to a variety of cancers. Multiple companies have developed MSI assays to detect a variety of early-stage cancers. The US Food and Drug Administration (FDA Silver Springs, MD, USA; www.fda.gov) has granted Breakthrough Device designation to two companies for their existing next-generation sequencing RUO liquid biopsy assays to include MSI detection. Under the program, the FDA works with a test developer to reduce the time and cost from development to approval. A scientific team from Memorial Sloan Kettering Cancer Center (MSKCC, New York, NY, USA; www.mskcc.org) recently presented unpublished validation studies on the Idylla microsatellite instability assay (Biocartis US, Inc, Jersey City, NJ, USA; https://us.biocartis.com)

demonstrating its ability to detect traces of tumor mutations in a variety of cancers such as endometrial and colorectal carcinoma. The MSKCC team validated the use of the Idylla MSI assay for ultrarapid assessment of MSI status on formalin-fixed, paraffin-embedded (FFPE) tissue sections without the need for prior DNA extraction or concurrent testing with a normal control. The team examined 52 tumor samples: 38 FFPE and 14 extracted DNA, with known MSI status and ran them on the Idylla MSI assay. The team labeled the samples based on the presence of instability in the seven markers: if the samples had two or more unstable biomarkers, they were considered MSI-H; if the samples had fewer than two unstable biomarkers, they were considered MSI stable (MSS). The team then compared the results to previously determined MSI status based on NGS data generated by MSK-IMPACT, a MSI-PCR tool (Promega Corporation, Madison, WI, USA; https://worldwide.promega. com) and an MMR immunohistochemistry assay. The team found concordant results for 24 of 25 MSI-H and 26 of 27 of the MSS cases between Biocartis and Promegaâ&#x20AC;&#x2122;s assays, for an overall concordance of 96%. The scientists required four minutes of hands-on time to run the assay, with about 150 minutes from setup to report generation. The investigators concluded that the Idylla MSI test is a simple and fully automated solution for MSI status determination, providing quick results that are concordant with other MSI testing approaches. The study was presented at the Association for Molecular Pathology annual meeting held November 1-3, 2018, in San Antonio, TX, USA (https://amp18.amp.org). Image: The Idylla microsatellite instability (MSI) assay cartridge (Photo courtesy of Biocartis).

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LabMedica International April/2019

Edited by Katherina Psarra MSc, PhD IFCC members may send news to: Katherina Psarra, MSc, PhD, Dept of Immunology â&#x20AC;&#x201C; Histocompatibility, Evangelismos Hospital, Ipsilantou 45-47, Athens 10676, Greece; Email: enews@ifcc.org

NEWS

IN MEMORIAM World's Laboratory Medicine Community Mourns Untimely Loss of IFCC President Prof. Howard Morris t is with great sadness that we announce the death of Prof. Howard Morris, President of the IFCC. Prof. Howard Morris passed away on 18th April 2019, while in Kazakhstan where he was lecturing as an IFCC Visiting Lecturer. Prof. Morris was an accomplished medical scientist, educator and administrator. Above all, he was a gentleman and a professional in all that he did. He will be remembered for his many contributions to Clinical Chemistry and Laboratory Medicine worldwide, especially in the area of Vitamin D and bone metabolism. He worked tirelessly in IFCC Committees including his most recent role as President of IFCC. The IFCC sends its condolences to his wife, Dr Helen Martin, and to his family and friends. Prof Morris (PhD, FAACB, FFSc(RCPA)) held a joint appointment as Professor of Medical Science at the University of South Australia and Clinical Scientist in Chemical Pathology at SA Pathology, Adelaide Australia. He had 30 years experience working in diagnostic clinical biochemistry in the field of immunoassay and endocrinology and this fuelled his research interest in the pathophysiology of metabolic bone disease and the effects of hormones, including vitamin D. His active research team had received over 10 million $AUD in competitive research grants and he had published >280 refereed publications, reviews and book chapters. He recently identified anabolic actions of vitamin D following metabolism within bone tissue providing a molecular mechanism for vitamin D requirement to reduce the risk of fractures among the elderly. Within Australia, Prof Morris was the Australasian Association of Clinical

LabMedica International April/2019

Biochemists (AACB) representative to the Councils of IFCC and APFCB (1998- 2004); served on the AACB council (1998-2002) and was Editor of the Clinical Biochemist Reviews (1994-2002). He was awarded the AACB Outstanding Service Medallion (2003) and the W. Roman Travelling Lectureship (2004). Also he was awarded the Louis Avioli Memorial Lectureship for 2009 by the American Society for Bone and Mineral Research on this topic. Within the Asia-Pacific Federation of Clinical Biochemistry (APFCB) Dr Morris served as Chair, Scientific Committee (2002-2004) and Chair, Scientific Organising Committee, Member Organising Committee for 10th Asian Pacific Congress of Clinical Biochemistry (2002-2005). Prior to his election as IFCC, President Prof Morris had served as IFCC Vice President (2012-2014); Secretary of the Scientific Division (20032008); Chair of the IFCC-International Osteoporosis Foundation Joint WG on the Standardization of Bone Turnover Markers (2012-2017); as a member of the IFCC Task Forces on the Global Campaign on Diabetes Mellitus (2003-2008), and on International Clinical Liaison (2009-2011). Prof Morris was elected as IFCC President in 2016, served as President Elect during 2017, and became President for a three-year term of office on January 2018. His passing is a great loss to all of us. All friends and colleagues will remember Prof Morris with love, affection and high respect.

NEWS

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

IFCC Programmes for Personal Support FCC is pleased to announce the operation of the newly created IFCC Working Group for Personal Support (WG-PS), which is part of the Education and Management Division. The WG-PS brings together two previous IFCC programmes that offer one-to-one support to individual Laboratory Medicine specialists: The IFCC Register of Experts The IFCC Mentoring ProPast President Graham Beastall, gramme Chair of WG-PS A brief description of each programme is given below together with links to access the services offered by WG-PS. Further details of WG-PS can be found on the IFCC website by using the following link: www.ifcc.org/ifcc-education-division/working-groups-special-projects/wg-ps/

Register of Experts: IFCC has established a database of experts from around the world who have offered to share their scientific or management expertise with senior trainees or newly qualified Laboratory Medicine practitioners. The collaboration will be short-term and will relate to a specific topic raised by the enquirer. Practitioners wishing to contact an Expert should use the link below. This will take you to the list of available expertise and the experts who are willing to provide information or advice. To contact an Expert, it is necessary for the enquirer to complete a short form, which is submitted to the IFCC Office. The WG-PS will then arrange an introduction to the

most appropriate Expert. To contact an Expert, go to: www.ifcc.org/ifcceducation-division/experts IFCC is keen to expand the number of Experts on its database. Therefore, the WG-PS invites senior practitioners with expertise in one or more areas of Laboratory Medicine to apply to be an Expert. This process involves completion of a short form, which is submitted to the IFCC Office for consideration by WG-PS. To apply to be an Expert go to the WG-PS website page and download the form.

Mentoring Programme Mentoring is defined as a voluntary process in which an experienced individual helps another person develop his or her goals and skills through a series of time-limited, confidential, one-on-one conversations and other learning activities. Therefore, mentoring is more broadly based and is likely to take longer than contacting an Expert on a specific topic. The experienced individual in a mentoring relationship is known as the Mentor. The individual seeking support is known as the Associate (or Mentee). The IFCC Mentoring programme is intended to support Associates who are in the final stages of their training as Laboratory Medicine specialists or who are newly appointed Clinical Laboratory directors who are seeking to improve the quality of their laboratory with the aim of laboratory accreditation. Typically, Associates are based in developing countries whilst Mentors are experienced, including recently retired, Laboratory Medicine specialists. Associates wishing to apply to access the Mentoring programme should use the link below. This will take you to a short registration form, which is submitted to the IFCC Office. The WG-PS for will evaluate the application and then arrange an introduction to the most appropriate Mentor. To request Mentoring, go to the WG-PS website page and download the form; IFCC is keen to expand the number of Mentors on its database, including those who speak languages other than English. Therefore, the WG-PS invites senior laboratory directors, including recently retired persons, to apply to be a Mentor. This process involves completion of a short form, which is submitted to the IFCC Office for consideration by WG-PS; To apply to be a Mentor, go to the WG-PS website page and download the form. Past President Graham Beastall, Chair of WG-PS, offers the following comment on the operation of the Working Group. “One of the strengths of IFCC is its global network of Experts and senior professionals who are willing to support more junior individuals and/or practitioners from developing countries on a one-to-one basis. WG-PS aims to utilise this network. WG-PS is an unusual IFCC programme because it targets individual Laboratory Medicine practitioners rather than IFCC Member societies or companies. To be effective WGPS needs help to promote its two programmes to individuals and we have asked IFCC Members to help us to do this. In addition, we will be using our Young Scientist network and social media to help spread the word. Ultimately, the success of WG-PS will depend on our ability to reach the individuals who can benefit from the personal support programmes. Please draw the attention of this article to your colleagues and refer them to: www.ifcc. org/ifcc-education-division/workinggroups-special-projects/wg-ps” Any queries about WG-PS should be addressed to Silvia Cardinale in the IFCC Office (ifcc@ifcc.org).

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 LabMedica International April/2019

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

NEWS

Accreditation in Lab Medicine: What’s Next? Dr Bernard GOUGET, Chair-Human Health Care Committee-Cofrac; Chair, IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MHBLM), SFBC-International Committee, General Secretary of the International Francophone Federation of Clinical Biology and Laboratory Medicine (FIFBCML); Counselor for Public Health-FHF; and Héléne MEHAY, Director Human Health Care Section-Cofrac, France he first “Accreditation & Human Health Forum” held by Cofrac took place on November 6, 2018 at the Salons de l’Aveyron in Paris (FR). Dedicated to the theme “accreditation, a lever for healthcare efficiency and safety”, this event welcomed more than 500 healthcare professionals concerned by accreditation (Laboratory Medicine specialists, pathologists and cytology specialists, radiologists, hospital managers, biomedical engineers, risk and quality managers, technicians, patient’s associations, Regional Health Authority representatives, etc… and members of the Human Health section of Cofrac. This first Accreditation & Human Health forum under the patronage of Ms. Agnès Buzyn, Minister of Solidarity and Health, made it possible to take stock of accreditation in Laboratory Medicine and to put in perspective the improvements and optimizations expected and the 2020 deadline. It also permitted discussing accreditation of delocalized Laboratory Medicine testing (POCT) as well as the voluntary accreditation of the pathological anatomy and cytology specialists, and the expansion in the near future of accreditation into the field of medical imaging, at the request of medical imaging professionals. The first roundtable, coordinated by Bernard Doroszczuk, Director-General of Cofrac, in the presence of Catherine Grenier (French National Health Authority, HAS), Patrick Boutinon (France Assos Santé), Prof. Jacques Isopet (CHU Toulouse), François Cornu (Eurofins Biomnis) and Franck Lebeugle (AFNOR Certification), was dedicated to quality expectations, approaches and tools in healthcare. Three major lessons were learned: Patient satisfaction must be considered in evaluating healthcare organizations, as well as the quality of medical laboratory services. This expectation has become one of the priorities of the “Ma Santé [My Health] 2022” plan that relates to improving healthcare quality and the appropriateness of procedures; Quality approaches must evolve by integrating new indicators measuring the results of patient management and by simplification for better compliance of healthcare professionals; Digitization and artificial intelligence are tools that will permit improving diagnostic capacity via an infinite database analysis capacity. These tools, which will redefine the role of the Laboratory Medicine specialist and their relationship with clinicians and patients must be quickly integrated into healthcare. The second round table, coordinated by Bernard Gouget, Chairman of the Human Health Section Committee, demonstrated the leading role played by France in Europe and internationally. Wim Huisman, representative of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) confirmed that ISO 15 189 is now deployed in all European countries and recognized as an essential standard, whether accreditation is mandatory or voluntary. According to Lorraine Turner (UKAS), the United Kingdom is very advanced in the diversity of medical sector accreditations, especially in imaging and oncology, and standard ISO 15 189 is predominantly applied. The Joint Research Centre of the European Commission as an internal scientific department of the European Commission is at the center of research and study of quality assessment methods in healthcare sectors. Luciana Neamtiu underlined all the benefits that an innovative approach could have in setting up a standard care pathway in the treatment of breast cancer, based on accreditation in Laboratory Medicine, pathology and medical imaging, as well as on the evaluation of good healthcare practices, in a harmonized European vision. Anne-Sophie Degryse (Union of the In-Vitro Diagnostics Industry, SIDIV) reported on synergies between Laboratory Medicine specialists and the in-vitro diagnostics industry described in the “provider charter” as a support for the accreditation process, and the challenges posed by new technologies in the face of increasingly stringent European regulation. “Healthcare accreditation is undeniably a substantial international movement today, reported Etienne Couelle, CEO of Synlab France. Beyond categorial interest, Laboratory Medicine accreditation is a source of harmonization of practices internationally, of excellence in services and optimization of Laboratory Medicine. The entire activity can be accredited, he added, and can only increase the confidence of users and patients in the quality of services rendered.”

LabMedica International April/2019

The afternoon was dedicated to assessing Laboratory Medicine accreditation in France. Currently, 819 private and public medical laboratories are accredited for at least 50 % of their activity. These figures prove that the profession was able to reorganize itself by appropriating the mandatory "accreditation tool", in a context of changing healthcare needs and economic restructuring. The afternoon workshops, led by Cofrac teams, took stock of the Laboratory Medicine accreditation process, its evolution and development. Hélène Méhay, Director of the Cofrac Human Health section, reported on strategic focuses: optimizing and simplifying the accreditation process, notably by making processes digital and adapting evaluation protocols; recruiting and training evaluators; supporting development, in particular delocalized Laboratory Medicine and anatomical pathology and cytology testing and medical imaging; improving the accreditation service and its added value, especially by improved communication. Prof. Jérôme Salomon, Director-General of Health, closed the forum and put Laboratory Medicine into perspective in the face of the challenges of healthcare system reform. “Laboratory Medicine has become a critical element of the care pathway for our fellow citizens, stated Jérôme Salomon. We no longer talk about complementary examinations, but rather a three-part medical approach associating Clinical and Laboratory Medicine and Imaging.” The Director General of Health emphasized the important role of Laboratory Medicine specialists in antibiotics resistance and prevention of chronic diseases, and their role in the development of molecular biology, especially in the context of the France Genomic Plan for 2025. “Laboratory Medicine is currently one of the drivers of healthcare progress. This gives you great pride but also great responsibility”, concluded Jérôme Salomon.

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

IFCC Task Force for Young Scientists: “TEAM” IFCC-TF-YS By Porf Pradeep Kumar Dabla, IFCC TF-YS Chair, Associate Prof., Department of Biochemistry, G.B. Pant Institute of Postgraduate, Medical Education & Research (GIPMER), India eam is described simply as “a group of people who are working through collective endeavour toward a common goal”. Successful teams can help transform an organisation, increase outputs and deliver on organisational objectives. IFCC initiated Task Force – Young Scientists (TF-YS) in 2010 with the aim to ensure that young scientists make a significant and growing contribution to the activities of IFCC and other National programmes. IFCC-TF-YS able to cross the barrier and created a strong young scientists support group involving 47 members globally. We use modern information technology & social media to establish networks and facilitating the communication, 24/7 using Facebook, Twitter, LinkedIn and others. We partnered with other National and International societies to deliver educational workshops, trainings, mentorship programmes, webinars to learn perspectives and principles of Laboratory Management & Leadership namely “IFCC-TF-YS Survey”, “IFCC-TF-YS Mentorship Programme”, “Research Booklet”, “Young Scientists Awards & Grants”, Webinars and Lab-Surfing. TF-YS is working with commitment to help the new generation facing challenges in the field of Laboratory Medicine. TF-YS is thankful to our outgoing members Danni Li, Omolara Olutosin Popoola, Miljan Savkovic and appreciate all their efforts as Team. We wish them success for their new ventures. TF-YS also welcomes our new core members: Giulia M. Sancesario, Italy. University Hospital of Tor Vergata, Rome, Italy, Chair of Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) Working Group of Young Scientists (YS-WG). My current research is in the field of translational medicine, in the discovery and validation of novel biomarkers in complex diseases. Since

2017 I have been the Chair of the SIBioC Young Scientists working group (SIBioC-YS). Promoting the development of cooperation mechanisms and training programs among young specialists in Laboratory Medicine is a fundamental challenge for scientific societies. Furthermore, the strength of young scientists is a precious resource that must be grown.

Joe El-Khoury, USA. Co-Director of the Clinical Chemistry Laboratory and fellowship program at YaleNew Haven Health and Assistant Professor of Laboratory Medicine at Yale University in New Haven, CT, USA. His research interests include mass spectrometry methods, pre-analytical errors, and markers of kidney disease.

Ashlin Rampul, South Africa. Training to become a chemical pathologist and he is a registrar/resident in Chemical Pathology in the department of Chemical Pathology, University of Pretoria and National Health Laboratory service. He holds a Bachelor of Medical Science Hons degree (cum laude) and a Bachelor of Medicine, Bachelor of Surgery degree (MBChB)(equivalent to US MD degree). He holds various leadership positions within his community. His major interests being to extend the mentorship programme across the African continent especially because of the great need and also the need to develop science amongst disadvantaged communities especially within the African continent. We wish to achieve new success stories with “TEAM TF-YS”. For more details: http://www.ifcc.org/task-force-young-scientists-web-pages/

e-Cardiology in Moscow: Connecting Clinicians and Technology to Implement eHealth in Daily Practice Dr Bernard Gouget, chair IFCC-MHBLM, Prof. Damien Gruson, EC-member IFCC-ETD, Prof. Sergio Bernardini, Chair, IFCC-ETD igital Health will have a great impact on the way specialists in Lab Medicine, and medical professionals work and interact between themselves and with their patients. New tools and data will change our daily professional activities. S. Bernardini, Chair IFCC-Emerging Technology Division (ETD), D. Gruson, Member EC-ETD and B. Gouget chair, Committee on Mobile Health and Bioengineering in Lab Medicine (C-MHBLM), were invited by Prof. Enrico G Caiani, PhD, Chairman ESC WG on e-Cardiology, Instituto di Elettronica e Ingegneria del l'Informazione e delle Telecomunicazioni (IEIIT-CNR) Milano (IT) to participate at “the 5th European congress on e-Cardiology and e-health” in Moscow (RU), on October 29-30th 2018” chaired by Prof. Philipp Kopylov, Sechenov UniversityMoscow, Head of Institute of personalized medicine and Prof. Hugo Saner, Swiss Cardiovascular Centre, University Hospital Bern (CH). The congress center was located at the Ivan Sechenov University, in Moscow, one of the most prestigious largest research medical university in Russia. Today, the university has many partnerships with different foreign universities and organizations. Its main areas of research are molecular medicine, personalized, regenerative and translational medicine. The Sechenov University is the leader in medical education and a platform for the development and implementation in clinical practice on e-health and e-cardiology. This medical congress had the aim to contribute to a successful translation from research and development to clinical applications of digital health by bringing the various stakeholders together: clinicians, mathematicians, IT specialists, bioengineers, academics, economists and many others. The scientific program was officially endorsed by the International Society for Telemedicine and eHealth (ISfTeH), the European Health Telematics association (EHTEL), and the Russian Societies of cardiology, heart failure, arterial hypertension, and Clinical electrophysiology and cardio-stimulation. This event provided multilateral dialogue clinically oriented on the development and implementation of modern and digital technologies. For the first time, IFCC gave its auspices at a medical event on e-cardiology contributing to build a stronger bridge connecting with clinicians, other key stakeholders and representatives of the major Cardio device Companies. It was interesting to discover at the exhibition, the miniaturization trends with cardiology devices, as the new leadless pacemakers, the novel design of stents, the new heart-monitoring and wireless devices. Cardiology

remains the second-biggest medical device area. It was also surprising to see that many bio-medical companies are moving from strictly being a manufacturer to a service provider helping health systems to better manage populations (i.e., instead of being a device maker, biomedical companies are becoming a management company targeting chronic diseases) The e-Cardiology congress covered a wide area of specialized computer methods in cardiovascular image processing, computational knowledge discovery, artificial intelligence, intelligent data analysis, bio-signal processing, signal modelling, databases, intra- and inter-hospital communication, e-health and mobile applications, and predictive models development. It was really the perfect infrastructure for the IFCC-ETD team to interact on the topic “Smartphone as a lab”. Pr. Bernardini presented an update on POCT for cardiac biomarkers, Dr. Gouget paved the way for eLaboratory Medicine and Pr. Gruson discussed the smart digital lab and new applications in cardiology. The interdisciplinary nature of this conference provided a niche to discuss up-to-date technological applications representing an added value on the EDT actions. It allowed to establish productive collaborations with clinical and bioengineering associations. It was also an opportunity to reinforce our knowledge on the emerging field of e-Health, including patient management and monitoring of “implanted” devices, telehealth and telepresence, mobile apps development and evaluation, patient empowerment and digital health literacy, and big data analytics. The IFCC team enjoyed Moscow after the session. It was impossible to miss the beautiful historic Metro and the Red Square, heart and soul of Russia and the most famous landmark of the city with its fantastic sights such as the St Basil’s Cathedral as well as the symbolic Great Bell Tower and the Lenin Mausoleum. We strolled around the Kremlin to appreciate its fantastic sights such as the Assumption Cathedral which held the ceremonies of Tsars and Emperors; also visited the Bosco Café inside the historic shopping mall GUM, totally illuminated during the winter festivities. Before departing, a social dinner has hosted at the Caucasian restaurant “Sherwood” with Prof Oleg Medvedev from the Lomonosov Moscow State University, allowing us to force the boundaries of cardiovascular science discovering the values of Vodka such as preventing clots, strokes and other heart diseases…, if consumed with moderation! LabMedica International April/2019

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

NEWS

CALILAB 2018: Argentina’s 10th National Congress Held in Buenos Aires By Rosa Sierra-Amor, PhD, Member, eNews, Regional Representative IFCC; Nilda Fink, PhD, Chair, Scientific Committee, CALILAB 2018 he 10th CALILAB 2018 Congress organized by the Argentine Biochemistry Foundation, (FBA in Spanish) under the auspices of CUBRA, IFCC National Society, and held in the city of Buenos Aires from October 24-27, 2018, at the recently opened Convention Centre taking place in October 24-27, 2018. The success of this 10th edition was the result of a rich scientific program and high academic level. The attendance was 2,000 participants, 660 professionals registered for the courses, a record of 275 abstracts summited and the participation of 30 diagnostic companies in the Lab Expo as sponsors were so well received. The activities proposed by the industry offered several alternatives for participants attending to an enriching experience on four days of the Congress. The opening ceremony was attended by numerous colleagues, and various institutions as the IFCC, COLABIOCLI, Foundation José Luis Castaño, and Unified Confederation of Biochemistry of the Republic Argentina (CUBRA), among others. Photo 1. Dr. Nilda Fink highlighted the team work carried out by members of the Scientific Committee, hosting 18 invited from different countries, Brazil, Canada, Colombia, Paraguay and Uruguay. It should be noted that through the IFCC-Abbott VLP Program three leading experts participated this year, Dr. Rosa Sierra-Amor, Prof. Maurizio Ferrari and Dr. Bernard Gouget. Also, with the economic support of the Foundation José Luis Castaño from Spain, it was possible that Dr. Yayhoui and Dr. Queraltó Compaño participated too. Dr. Claudio Duymovich, President FBA and the Organizing Committee of the Congress stressed the fact that professionals were very committed to quality and considered that CALILAB was for all, laboratories of urban centers up to those far away in Argentina, and unique opportunity to be updated in a world of technological changes. The Congress Opening Lecture was given by Dr. Khosrow Adeli, a renowned Canadian specialist, Chairman of the Committee of Communications and Publications of the IFCC, and Professor of Clinical Biochemistry at "The Hospital for Sick Children", University of Toronto, Canada: "Value and impact of the Clinical Laboratory in health care". In addition, the scientific program included two plenary lectures, 18 simultaneous conferences and 18 symposia. As part of the Educational Program, there were 6 pre-Congress courses, 3 courses intra-congress and 9 workshops. An important number of approved abstracts were presented in the program as free communications. During the Closing Ceremony, the following awards were given to: 1st Place: Towards harmonization of molecular diagnostic methods: Burden of Epstein-Barr virus in Argentina II-first international standard WHO-EBV calibration strategies. By Fellner, MD, Durand KA, Rodriguez MA, Irazu L, Picconi MA. Grupo de estudio diagnóstico de EBV en Argentina, Laboratorio Nacional de Referencia de EBV-ANLIS “Carlos G. Malbrán”. 2nd Place: Development and preliminary validation of a method of inmunotransparencia applicable to the diagnosis of Multiple Sclerosis. By Facio ML, García M, Alejandre M, Yasuda E, Bresciani P. Facultad de Farmacia y Bioquímica de la Universidad de Buenos Aires. 3rd Place: Reference intervals of new parameters in blood of a pediatric population. By: Benavides C, García RV, Goedelmann CJ, González Cid MP, Sala MC, Chaler EA, Durando MC. Hospital de Pediatría Garrahan.

LabMedica International April/2019

Photo: (Opening Ceremony CALILAB 2018, from left to right) Prof. Maurizio Ferrari, Past-President IFCC, Rosa Sierra Amor, IFCC Regional Representative COLABIOCLI, Nilda Fink, Chair, Scientific Committee, Claudio Duymovich, President FBA, Stella Raymondo, President COLABIOCLI and Alejandra Arias, President, CUBRA.

Also, 7 honorific diplomas were given to very high quality abstract presentations. The COCERBIN award was given to: Towards harmonization of molecular diagnostic methods. Load of Epstein-Barr virus in Argentina IV, new approaches to the performance of multicenter. By Rodríguez, MA, Irazu L, Fellner MD, Durand KA, Picconi MA. Laboratorio Nacional de Referencia, EBV-ANLIS “Carlos G. Malbrán”.

NEWS

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

The IFCC-CMHBLM On-the-Go by Dr. Bernard Gouget Chair, Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MHBLM), Past-Chair, IFCC Nominations Committee (NC), SFBC-International Committee; General Secretary of the International Francophone Federation of Clinical Biology and Laboratory Medicine (FIFBCML); President Healthcare Division Committee - Comité Français d’accréditation (Cofrac)

igitalization has been a revolutionizing movement in manufacturing and since then moved into many areas in society including medicine. The use of modern technologies and digital services are not only changing the way we communicate, but also offering very innovative ways for monitoring health and well-being of populations. The reach of mobility transcends the boundaries of health, Information, knowledge, and services accessed anywhere, anytime, it is transforming the way how medical laboratories and health organizations are operating bringing a paradigm shift in healthcare delivery processes. The digitalization of healthcare is becoming inevitable, the amount of medical knowledge continuing to grow rapidly. Under the term “digital health”, advanced medical technologies, disruptive innovations and digital communication have gradually become inseparable from providing best practice healthcare. Digital health encompasses many subsectors including e-health, telehealth, telemedicine, health information technology and m-Health. M-Health is revolutionizing approaches to patient care and management, point-of-care support, health education, remote monitoring, diagnostics, supply chain management and logistics and more. Mobile phones and other remote monitoring devices have the ability to transform the delivery of health services all over the world. The growing appeal of mobile solutions for health promotion and health care delivery can be attributed in part to the accessibility of the technology, the level of personalization that technology enables, valuable locationbased services, and timely access to information through data, voice, and/or video media. The increased dissemination of mobile devices as well as the expanding wireless network coverage provides new possibilities to address challenges associated with accessibility, quality, effectiveness, efficiency and cost of healthcare. M-Health is no longer just another buzzword, it is gaining a lot of momentum in the coming years. Medical practitioners and lab professionals are using mobiles and tablets not only for personal use but also for various aspects of their profession. M-Health can enhance the communication between healthcare providers and patients. It empowers patients to take charge of their health on their own. Additionally, m-Health is being used for storing patient records, interconnectedness with patients using wearable devices, emergency response and management, location-based medical services, etc. The increased number of mobile devices, their operation by non-professionals together with the use of health apps will enormously increase data volumes while decentralizing the flux of health data. As the central provider of diagnostic health care information, the medical laboratory can expect to be widely affected in the predictable future by the new developments in m-Health and its impact on data integration and communication. These capabilities also pose new ethical challenges that the specialist in lab medicine will need to manage. By reassessing classical tasks as well as adopting new ones, digitalization in lab medicine will provide exciting time and will address new challenges for the specialists in laboratory medicine at improving the health and wellbeing of each human person and specially of some of the world’s most vulnerable populations. The times ahead with digitalization and m-Health are both exciting and challenging. Also, an IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine (IFCC-CMHBLM) was established at the beginning of 2019 as a part of the IFCC-Emerging Technologies Division. The full members are: Kazuhiko Kotani (JP), James Harold Nichols (US), Frank Desiere – Roche (CH) and Mike Heydlauf – Siemens (US). As corresponding members, Anna Füzéry (CA) and Zihni Onur Uygun (TR); Ramy Khalil (EG) is the Young scientist; Damien Gruson (BE) acts as EC-ETD liaison, and Bernard Gouget (FR) as CMHBLM chair. The C-MHBLM envisions a world where digitalization

and m-Health innovations support improved health and contribute to better quality, accessibility and sustainability of health services and health outcomes, not only in the developed countries but also in the fragile and underserved populations in low resource environments. The mission statement emphasizes both innovation and goal of universal access. The C-MHBLM aims to provide guidance to promote use of increased confidence in health apps and smart devices by supplying good practice guidelines for IFCC members and the healthcare community relevant to Clinical Chemistry and Laboratory Medicine, directed at scientific, managerial, clinical, ethical and patient issues. To accomplish this mission C-MHBLM will: Review the current concepts of digitalization, e-Health and m-Health, Promote the potential of e-health and m-Health in laboratory medicine to improve service delivery for patients with more medical-cost effective models of care; Conduct a systematic review of the literature to evaluate the effectiveness of m-Health such as in supporting the adherence of patients to chronic diseases management; Identify m-Health areas of relevance to Clinical Chemistry and Laboratory Medicine, that will affect the expertise of the lab professionals and the organization of the medical laboratory; Facilitate integration of m-Health into routine practice and guide specialists in Lab Medicine to function optimally with these new connected technologies in a changing environment; Establish collaborations and partnerships with the other organizations concerned with e- Health /m-health and clinical societies and international organizations/bodies; Promote an environment where digitally enabled and integrated systems help specialists in laboratory medicine to deliver patient-centered health experiences and quality health outcomes; Actively participate in programs of IFCC Congresses and Scientific Meetings; Produce IFCC documents; Respond to the needs of IFCC Members in Digitalization, Artificial intelligence and mHealth managerial skills as well as those of the Corporate Members. The C MHBLM will implement this strategy by: Leadership: Pproviding IFCC leadership in digital health (mHealth, eHealth, and ICTs); Knowledge management: To provide Lab professionals with knowledge, skills on how to make the best use of m-Health ad ICT in healthcare; Communication: Facilitating sharing of experiences, lessons learned and resources and offering a collaborative gathering space for IFCC members to exchange perspectives on digital health topics, resources, and practical guidance related to implementation across a range of technical and clinical areas (lectures, congresses, e-discussions, evidence-based guidelines…); Promising Practices: Identifying, developing, promoting and advising the best available approaches for the development, implementation, and evaluation of digital health projects and practices as well as creating and sharing tools and resources that enable adoption of promising practices and their adoption; Collaboration: Fostering dynamic exchanges between IFCC and ICT industry and identifying and facilitating opportunities for joint activities and partnerships. The future is coming and is coming quickly, the digitalization of the healthcare sector comes with immense opportunities. We are entering in the new unplugged medicine. On top of large amounts of quality data, a change in culture in the sector and solid evidence-based outcomes are still necessary for m-Health and AI to be adopted in the workplace. Within the federation, we need to be visionaries to discuss the future of digitalization of lab medicine, to overcome certain barriers before it can take full advantage of the benefits of digitalization and to consider the best ways to leverage mobile technology with a focus on patient relevant outcomes!

The views and positions expressed in the IFCC News section are those of the IFCC or the individual authors, and do not necessarily represent the views or positions of LabMedica magazine or its publishers.

LabMedica International April/2019

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Industry News

Baxter - bioMérieux Alliance to Develop Acute Kidney Injury Diagnostics axter International Inc. and bioMérieux announced an agreement to develop future biomarkers with the goal to rapidly identify and inform treatment of acute kidney injury (AKI). The announcement was made at the International Symposium on Intensive Care and Emergency Medicine (ISICEM) this week. Additional details about the agreement were not disclosed. AKI is a sudden decrease in kidney function over a period of hours to days, often the result of illness, trauma or infection. The sudden loss of kidney function leads to the accumulation of toxins and fluid in the blood that, if left untreated, may lead to death. The most severe stage of AKI requires renal replacement therapy (“dialysis”) to replace the function of the kidneys. AKI is an increasingly common complication of acute illnesses in intensive care units and hospitals and early diagnosis is critical. “As a leader in pioneering diagnostic solutions, we’re looking for-

ward to collaborating with Baxter to address the important challenges in critical care medicine such as AKI. In order to accomplish this, the team at the recently-acquired Astute Medical is committed to the development of additional high medical value biomarkers for improved patient care,” said Mark Miller, Executive Vice President, Chief Medical Officer at bioMérieux. A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux (Marcy l'Etoile, France; www.biomerieux.com) is present in 43 countries and serves more than 160 countries with the support of a large network of distributors. In 2018, revenues reached ğ2.4 billion, with over 90% of sales outside of France. With products, technologies and therapies available in more than 100 countries, Baxter (Deerfield, IL, USA; www.baxter.com) offers an extensive portfolio of critical care, nutrition, renal, hospital and surgical products.

Beckman Coulter in Partnership with Apostle eckman Coulter Life Sciences (Indianapolis, IN, USA; www. beckmancoulter.com) has entered into a partnership with Apostle Inc. (Menlo Park, CA, USA; www.apostlebio.com) for the launch of Apostle MiniMax High Efficiency Cell-Free DNA Isolation Kit, a magnetic nanoparticle-based kit to extract circulating free DNA (cfDNA) from plasma using manual or automated workflows. Beckman Coulter Life Sciences develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Apostle is dedicated to fundamentally improving the accuracy and efficiency of liquid biopsy – the testing of cfDNA – in early cancer detection or other clinical applications, such as non-invasive prenatal testing (NIPT) and tests for infectious diseases. As cfDNA workflows move beyond the-

oretical and into human health applications, Apostle's industry-leading chemistry, paired with Beckman Coulter Life Sciences’ portfolio of genomic reagents and liquid handling platforms, enables researchers to meet the growing demands for sequencing of tumor-derived cfDNA. Due to limited cfDNA concentration, sufficient yield for next-generation sequencing (NGS) or other downstream applications can require higher volumes of plasma. As the volume increases, issues such as recovery efficiency and workflow complexity often arise. Plasma contains a host of contaminants that are problematic at this scale and can reduce assay sensitivity. Apostle MiniMax technology performs reliably across a range of volume inputs, consistently recovering high quantities of cfDNA, while effectively removing contaminants.

Global Digital Pathology Market to Reach USD 600 Million by 2022

Karl Hecht Celebrates 100-Year Anniversary

he global digital pathology market is projected to grow at a CAGR of 8.5% from 2017-2022 to reach USD 600 million by 2022, despite the presence of headwinds that are suppressing market potential and limiting its growth. These are the latest findings of Signify Research, (Cranfield, Bedfordshire, England; www.signifyresearch.net), an independent supplier of market intelligence and consultancy to the global healthcare technology industry. Despite its early hype, the world market for digital pathology, comprising whole slide scanner hardware, software and services, remains at a nascent stage, although it is showing signs of gaining momentum. The first FDA approval of a digital pathology solution for primary diagnosis in the US in 2017 was a landmark, although no other system has received approval since then. Additionally, the successful implementation of regional digital pathology networks in Northern Europe could act as blueprint for other health systems. The strong trend towards consolidation of services in healthcare is driving several clinical hospital networks and clinical laboratories to centralize and consolidate their networks, which is expected to create larger “hubs” for digital pathology. The adoption rate of image analysis software and computational pathology in the pre-clinical pharmaceuticals and life sciences sectors, especially in support of drug discovery, is expected to be higher as compared to the clinical segments. The hospital and clinical laboratory segments continue to grow and are expected to witness a stronger growth in the mid and long-term due to regulatory constraints, complexity of integration with existing clinical IT, and lengthy procurement cycles. However, the global digital pathology market also faces headwinds, such as the slow process of convincing pathologists to give up traditional microscopes for digital scanners and software viewers. Several healthcare providers and clinical laboratories have approached digitalization in a gradual manner, choosing to use digital workflow for only certain pathology diagnoses, or have adopted digital pathology for secondary uses, such as in clinical education or secondary review.

n 1919, Karl Hecht laid the foundation for the Glaswarenfabrik in Sitzendorf-Unterweißbach in Thuringia, Germany. Over the decades the company continuously specialized in production and distribution of precision glass instruments for physicians and laboratories. Due to the destabilization in postwar Germany, the company dared a new start in Franconian Sondheim vor der Rhön in 1945. The economic success led to the development of further locations in France, Austria, and Switzerland. Meanwhile the company, now called Glaswarenfabrik Karl Hecht GmbH & Co KG (Sondheim vor der Rhön, Germany; www.hecht-assistent.de) offers a broad spectrum of more than 4000 devices, instruments, and apparatus that cover laboratory and clinical equipment. The products are used, amongst others, with diagnostic examinations, microscopic and dyeing techniques, manual therapy, and measures of volume, density, and temperature. The glass instruments are still handmade, furthering the traditional glassblower craft activity. The distribution of the products is via medical-technical specialist trades.

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LabMedica International April/2019

Inq.No.

Advertising Index

Vol. 36 No.2 4/ 2019

Advertiser

Page

P O R T A L

2 E ASY WAYS

LabMedica International

– 122 – 115 126 – 119 109 105 107 – 110 124 125 – – 121 120 113 136 102 103 117 108 106

AACC Annual Meeting 2019 . . . . . . . . . . . . . . .27 Alcor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22 APFCB 2019 . . . . . . . . . . . . . . . . . . . . . . . . . . .35 Beckman Coulter . . . . . . . . . . . . . . . . . . . . . . . .15 Bioron . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26 COLABIOCLI 2019 . . . . . . . . . . . . . . . . . . . . . . .34 DiaSys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19 ELITech Group . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Erba . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 Erba . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7 EuroMedLab 2019 . . . . . . . . . . . . . . . . . . . . . . .31 Fujirebio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 Heales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24 Hecht, Karl . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25 LabMedica.com . . . . . . . . . . . . . . . . . . . . . . . . .11 MSACL 2019 EU . . . . . . . . . . . . . . . . . . . . . . . .29 Mayo Clinic Laboratories . . . . . . . . . . . . . . . . . .21 NG Biotech . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23 Nova Biomedicals . . . . . . . . . . . . . . . . . . . . . . .13 Randox . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36 Siemens Healthineers . . . . . . . . . . . . . . . . . . . . .2 SNIBE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 SNIBE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17 Vicotex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 Vircell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 Provided as a service to advertisers. Publisher cannot accept responsibility for any errors or omissions.

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