News Trend Analysis

Nov. 18, 2013

New Study

Unreliable commercial lab kits may be hindering cancer diagnostics. During the past 30 years, researchers have developed surprisingly few new tests for diagnosing cancer in spite of impressive advances in biomedical technology. A study appearing online in Clinical Chemistry, the journal of AACC, argues persuasively that low-quality commercial lab kits may be one factor hampering the progress of cancer diagnostics.

A doctor’s ability to test for cancer in its earlier stages often determines a patient’s chances of survival. Pancreatic ductal adenocarcinoma (PDAC) is a distressing example of this. The majority of patients live only three to 18 months post-diagnosis, because current diagnostic methods usually can’t detect PDAC until it is too advanced to respond to treatment. Testing for the right biomarkers could be crucial to the early detection of such cancers as PDAC.

Researchers led by Eleftherios P. Diamandis, MD, PhD, of the University of Toronto were hopeful they had found a new pancreatic cancer biomarker, the protein CUZD1, when they realized a faulty immunoassay kit had produced the data supporting CUZD1’s viability. Using a kit marketed for CUZD1 detection, the team had successfully differentiated between pancreatic cancer and benign patient samples. Further analysis, however, revealed that the kit performed well because it actually detected the established tumor marker CA125. CUZD1 and CA125 share no molecular similarities that explain this error. This means that lax quality control during the manufacturing of the kit most likely caused this mix-up.

Most investigators rely on commercial lab kits to evaluate the potential of candidate biomarkers. This study demonstrates, though, that costly risks counter the ease of using such kits. Because of the error, Diamandis’s team lost two years, approximately $500,000, and thousands of valuable patient specimens, while also inadvertently raising false expectations about a potential breakthrough in PDAC testing.

“Reports like this one are relatively rare in the literature, since negative results are not usually published,” says Diamandis. “However, these findings can contribute significantly to improving the quality of products intended for research purposes, and can save considerable research time and resources which would otherwise be wasted.”

In this paper, the authors propose experiments to confirm the reliability of commercial lab kits. They hope this will help other researchers avoid similar problems, while also speeding up the development of much-needed effective cancer tests. A podcast on this paper is available at

New Assay

Thrombin generation assay for commercial IVIG product release is validated. Haemtech Biopharma Services has announced the successful validation of a thrombin generation assay (TGA) for an intravenous immunoglobulin (IVIG) drug. The assay was validated in 2012 to support the use of TGA as a release assay for Biotest Pharmaceuticals Corporation’s U.S. Food and Drug Administration Biologics License Application for BIVIGAM (Immune Globulin Intravenous [Human], 10% Liquid) product. The validated TGA assay was designed and performed on the Calibrated Automated Thrombogram platform (CAT) from Diagnostica Stago, Inc.

TGA is a universal test capable of assessing a research subject’s global hemostatic balance in the case of hemorrhage or thrombosis. The CAT method is both specific and sensitive, thus giving increased relevance to hemostatic testing in academic research centers, pharmaceutical companies, and contract research organizations.

Using this specific method coagulation factor, XIa-like, procoagulant activity can be measured in IVIG and other plasma-derived therapeutics. In this way, the thrombogenic potential of these drugs can be measured and thus enable manufacturers to increase the safety of their drug product, and satisfy regulatory requirements on the road to product submission.

Disaster Response

CDC pushes for better, faster lab reports to help states’ outbreak response. Once labs detect dangerous infections, it’s crucial for information to get to health departments quickly and in a format that allows them to recognize disease outbreaks. The Centers for Disease Control and Prevention’s (CDC) efforts to speed this process and ensure that the best and most complete information about disease cases is reported is paying off, according to new data recently released in Morbidity and Mortality Weekly Report (MMWR).

A key to speeding lab reports is widespread adoption of electronic laboratory reporting (ELR) by labs that send reportable data to health agencies. ELR is an important tool that gives health officials vital information on infectious disease cases. Since 2010, CDC has provided funds to help 57 states, local and territorial health departments increase the use of ELR.

The MMWR  report shows that the number of state and local health departments receiving electronic reports from laboratories has more than doubled since 2005, when CDC last evaluated ELR reporting. In the past year, the number of individual reports received electronically increased by 15%. State and local health departments now estimate that 62% of total lab reports were received electronically.


AMP’s annual conference takes center stage this month. The Association for Molecular Pathology (AMP) 2013 Annual Meeting will be held in Phoenix November 14-16. It will feature more than 25 hours of cutting-edge sessions, a keynote presentation by the AMP 2013 Award for Excellence Recipient, nearly 400 posters, 150 exhibitors, and countless opportunities to interact directly with experts in this dynamic field.

A special feature is the Molecular Pathology Outreach Course, Current Applications of Molecular Pathology: Real Time Updates and Case Studies. This  one-day course is for pathologists, laboratory directors and technologists who wish to increase their proficiency with molecular pathology testing. Visit