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W O R L D S C L I N I C A L L A B O R AT O RY N E W S L E A D E R
ISSN 1068-1760 Vol. 30 No. 4 6-7/ 2013
DAILY CLINICAL LAB NEWS

Diagnostic Blood Test for Fibromyalgia Developed

ytokine-producing activity of immune cells of fibromyalgia (FM) patients has led to the development of a commercial blood test. The very real biological condition of FM takes an average of three to five years for someone with the illness to get an accurate diagnosis as hitherto there was no diagnostic
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Noninvasive Prenatal Test Screens Blood for Chromosomal Abnormalities

Rapid Molecular Test for Chikungunya Virus

novel molecular diagnostic platform with high sensitivity and specificity has been developed for the early detection of the Chikungunya virus (CHIKV). Chikungunya has reemerged as an important arboviral infection of global health significance and because of lack of a vaccine and
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hysicians will have access to a new noninvasive prenatal test, which uses cell-free fetal DNA in circulating maternal blood. The test, called Panorama, uses cell-free fetal DNA in circulating maternal blood to screen for chromosomal abnormalities associated with trisomy 21 (Down syndrome),

trisomy 18 (Edwards syndrome), trisomy 13 (Patau syndrome) and monosomy X (Turner syndrome). Panorama can be used as early as the ninth week of pregnancy. In December 2012, the American Congress of Obstetricians and Gynecologists (ACOG) issued a medical opinion stating that cell-free fetal
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Blood Test Tracks Response to Cancer Treatment

Image: Courtesy of Georgetown University Hospital

Process Offers Potential for New Biomarkers

cutting-edge technology has been developed that can successfully screen human blood for disease markers that may hold the key to better diagnosing and understanding of puzzling health conditions, including autoimmune diseases. The technology accurately identified human blood markers for
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blood test that tracks fragments of DNA shed by dying tumor cells could be used to monitor how well patients are responding to cancer treatment, as well as provide a non-invasive alternative to biopsies in advanced breast cancer.
See article on page 13
Image: A cluster of breast cancer cells showing visual evidence of programmed cell death

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Clinical News . . . . . . . 4-60 IFCCNews . . . . . . . . . . . 61 EFLM Corner . . . . . . . . . .66 Product News . . . . . 22-46 Technical Literature 58, 60 Industry News . . . . . . . . .68 International Calendar . 69
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Fully-Automated von Willebrand Factor Assay Panel Released

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he HemosIL AcuStar VWF assay panel offers the first fully-automated chemiluminescent system to use recombinant technology, allowing greater precision than platelet-based tests.
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Prostate Cancer Test Closer to Clinical Trial

breakthrough urine biomarker for prostate cancer will soon be available which will signal a significant step forward in the battle against prostate cancer. A protein called Engrailed-2 (EN2) is made by prostate cancers and secreted into urine where it can easily be detected in a small urine sample
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Novel Biomarker Detects Deadly Lymphoma

novel diagnostic test accurately identifies patients who have a new type of deadly intestinal lymphoma that is particularly common in Asia. The test will have an immediate impact on patient care, with doctors now able to diagnose patients accurately and tailor more effective treatment
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Process Offers Potential for New Biomarkers

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neuromyelitis optica (NMO), a rare autoimmune disorder resembling multiple sclerosis that can result in blindness and paralysis, by substituting antibodybinding targets with biologically unnatural molecules called peptoids. Scientists at Scripps Research Institute (Jupiter, FL, USA; www.scripps.edu) identified several peptoids that bound exclusively to antibodies in NMO patient blood serum and not healthy patients or patients with similar diseases, including multiple sclerosis (MS), lupus, Alzheimers disease (AD) and narcolepsy. At least one of the peptoids bound to an antibody that is well known to be associated with NMO. The team used the chemical library screening technology to identify a synthetic peptoid that binds anti-Aquaporin 4 (AQP4) antibodies in the serum of NMO patients. After processing the serum, slides were scanned on a GenePix 4200AL microarray scanner (Molecular Devices;

Sunnyvale, CA, USA; www.moleculardevices.com) by using the 488/635 nm laser at 100% power and a 500-photomultiplier-tube gain. The investigators screened 100,000 peptoids using a second-generation bead-based screening approach that yielded several peptoid ligands for the antigenbinding site of anti-AQP4 antibodies. They showed in a small preliminary study that the use of a small panel of these peptoids allows one to distinguish between NMO patient serum and serum from healthy controls or patients with MS, AD, narcolepsy, and lupus with high accuracy. Thomas Kodadek, PhD, the senior author of the study, said, We find disease biomarkers differently than anyone else. This enables new disease biomarker detection. Additionally, by using these peptoid hits to fish for disease-specific antibodies, the system enables disease-specific antibody detection without first knowing the antibodies natural binding targets. The study was published on March 21, 2013, in the journal Chemistry & Biology.

Published in cooperation with the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and European Federation of Clinical Chemistry and Laboratory Medicine (EFLM).
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Fully-Automated von Willebrand Factor Assay Panel Released

fully automated von Willebrand Factor assay has been released in Europe and international territories as a European CE in vitro diagnostic (IVD) Mark product under the European Directive on in vitro Diagnostic Medical Devices but not currently [US FDA] 510(k) cleared. A product of Instrumentation Laboratories (Bedford, MA, USA; www.instrumentationlaboratory. com/ilww), the fully automated HemosIL AcuStar VWF assay panel, designed exclusively for use on the ACL AcuStar Hemostasis Testing System, includes HemosIL AcuStar VWF Antigen (VWF:Ag) and HemosIL AcuStar VWF Ristocetin Cofactor (VWF:RCo) Activity assays. HemosIL AcuStar VWF:RCo is the first fully automated, chemiluminescent assay to use recombinant technology, allowing full automation and greater precision than platelet-based tests. It meets guidelines on VDF investigation and enhances accuracy versus manual methods. Chemiluminescence offers an enhanced linearity range to quantify extremely low levels of VWF concentrations. Like all reagents on the ACL AcuStar System, HemosIL AcuStar VWF assays are ready-to-use, cartridge-based and offer results in 30 minutes ondemand, 24/7. This is the third specialty assay panel

commercialized on the ACL AcuStar system. Previously introduced panels include Antiphospholipid Syndrome and Heparin-Induced Thrombocytopenia. With the ACL AcuStar Hemostasis Testing System, our goal is to automate complex assays and offer enhanced efficiency and sensitivity where it matters most, said Remo Tazzi, Director of Hemostasis Marketing at IL. Our new HemosIL AcuStar VWF assays achieve this, allowing clinicians to make quicker and more effective patient care decisions. VDF is an acquired or inherited bleeding disorder, caused by a qualitative or quantitative defect of the VWF protein. Whereas hemophilia mainly affects males, VDF is not gender-specific. The disease affects over 1% of the worldwide population and occurs in 1/100100,000 people with hemophilia. Acquired VDF can be associated with serious autoimmune problems (e.g., rheumatoid arthritis, systemic lupus erythematosus, and specific types of kidney failure or cancers) and may develop with no underlying conditions. Certain kinds of VDF may remain undiagnosed because symptoms can be mild. Prompt diagnosis and classification are necessary for optimal therapeutic management.

Dan Gueron Jill Roberge Jacqueline Miller, PhD Raymond L Jacobson, PhD Gerald Slutzky, PhD Andreas Rothstein Marcela Jensen Joseph Ciprut Brenda Silva Paul Mills Doris Mendieta Dr. Jutta Ciolek Christina Chang Arda Turac Elif Erkan

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Prostate Cancer Test Closer to Clinical Trial

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from men, allowing faster testing that could save lives and offer the potential for huge cost savings. The University of Surrey (Guildford, UK; www.surrey.ac.uk) where the test was originally developed has signed a worldwide nonexclusive agreement with international diagnostic specialist Zeus Scientific (Raritan, NJ, USA; www.zeusscientific.com) to develop and market its breakthrough urine biomarker, EN2. Urinary EN2 levels can be measured by an enzyme-linked immunosorbent assay and higher EN2 levels correlated with the stage of the tumor. In a joint statement, the University and the Prostate Project Charity (Godalming, UK; www.prostate-project. org.uk) who jointly funded the research, said: This is the news we have all been waiting for. In two years of extensive trials in the USA and Europe, EN2 has consis-

tently outperformed the 30-year-old prostate-specific antigen (PSA) test proving itself to be twice as effective at finding prostate cancer. Its accuracy has never been in doubt, but it has proved difficult to bulk test urine samples using conventional assay technology. Now, Zeus Scientific, one of the leaders in this field is confident it can overcome the problems and bring EN2 to market. Hardev Pandha MD, PhD, professor of Medical Oncology at the University of Surrey, said, The University of Surrey is looking forward very much to working with Zeus to introduce EN2 as a novel diagnostic test for prostate and bladder cancers. Our tests have shown that levels of EN2 correlate strongly with disease volume. Knowledge of disease volume may help urologists assess whether the patient has a small volume of disease that may be safely and actively monitored or a larger volume that needs to be treated.

ISSN 1068-1760
Vol.30 No.4. Published, under license, by Globetech Media LLC; Copyright 2013. All rights reserved. Reproduction in any form is forbidden without express permission. Opinions expressed are solely those of the authors, and do not represent an endorsement, or lack thereof, by the Publisher of any products or services.
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LabMedica International June-July/2013