April 2008 Clinical Laboratory News: Industry Profiles

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April 2008: Volume 34, Number 4

Quest Inks Deal with Epigenomics For Colorectal Cancer Biomarker

Epigenomics and Quest announced a non-exclusive licensing deal for Epigenomics’s proprietary DNA methylation biomarker Septin 9. Under the agreement, Quest has rights to uses of the biomarker to develop a molecular-based blood test to detect colorectal cancer. Quest plans to develop the Septin 9 DNA methylation test for use as a supplement to conventional methods of colorectal cancer screening, such as colonoscopy and FOBT. Research at Epigenomics showed that methylated DNA of the Septin 9 gene in blood plasma indicates the presence of colorectal cancer in early stages (Clin Chem 2008; 54: 414–423). “The availability of a simple blood test that can detect a biomarker for colorectal cancer will be a significant advance in the fight against this deadly disease, which is often curable when caught in the early stages,” said Joyce Schwartz, MD, VP and Chief Laboratory Officer for Quest. “Patient compliance in the U.S. with colorectal cancer screening guidelines is dismal. Too often, patients fail to undergo a colonoscopy or conduct other types of colorectal cancer screening because they find these methods invasive, unpleasant, or costly. A blood test for colorectal cancer, once developed, will be a convenient option that complements other screening methods.” In return for rights to the biomarker, Epigenomics receives upfront and milestone payments, as well as royalties on Quest’s sales of its Septin 9-based tests. Additional terms were not disclosed.

Geisinger, Celera Developing Unique Liver Disease Assay

Geisinger Health System and Celera announced a research collaboration aimed at developing a diagnostic assay to detect increased risk of non-alcoholic steatohepatitis (NASH), an advanced stage of non-alcoholic fatty liver disease (NAFLD) characterized by scarring and inflammation. The companies plan to evaluate Celera’s genetic findings in liver disease, including its Cirrhosis Risk Score, using Geisinger’s biorepository of more than 600 liver tissue samples and blood case-control samples donated from patients who have undergone bariatric surgery. Currently, a needle liver biopsy is the only way to definitively diagnose NASH. “Understanding the natural history of NAFLD and NASH, especially identification of those patients with or at risk for NASH represents a critical unmet diagnostic need in liver disease,” said Scott Friedman, MD, Fishberg Professor of Medicine and Chief of Liver Diseases at the Mount Sinai School of Medicine in a press release from Celera. “Associations of disease with various genes variants are beginning to provide keen insight into disease mechanisms that may be shared by multiple diseases.” Financial terms of the collaboration were not disclosed.

Cleveland Clinic, Google Experiment with Web-based Personal Health Records

Google’s much-anticipated health information storage program will get a trial run in a new pilot study being conducted in collaboration with the Cleveland Clinic. To kick off the program, Cleveland Clinic offered invitations to users of its own personal health record system called MyChart. The companies hope to attract 1,500 to 10,000 patients in order to test the secure exchange of medical record data between the two systems. “Patients are more proactively managing their own healthcare information,” said C. Martin Harris, MD, Chief Information Officer at Cleveland Clinic. “At Cleveland Clinic, we strive to participate in and help to advance the national dialogue around a more efficient and effective national healthcare system. Utilizing Cleveland Clinic’s PHR expertise, this collaboration is intended to help Google test features and services that will ultimately allow all Americans—as patients—to direct the exchange of their medical information between their various providers without compromising their privacy.” In an official Google blog post about the project, Google’s VP of Search & User Products, Marissa Mayer, describes what “sets Google Health apart,” including an interoperable platform meant to work with a variety of third parties, as well as Google’s trademark user focus and clean design. “We aren’t doctors or healthcare experts, but one thing Google can create is a clean, easy-to-use user experience that makes managing your health information straightforward and easy.” The official Google blog, which includes screenshots of Google Health, is available at Google Blog.

Abbott Gets Rights for xTAG Respiratory Viral Panel

Abbott Diagnostics announced a deal with Luminex for semi-exclusive U.S. distribution rights for Luminex’s new xTAG Respiratory Viral Panel (RVP). Cleared by the FDA in January, the xTAG RVP detects 12 viruses and viral subtypes from a single patient sample within hours (CLN, March 2008). “We believe that xTAG RVP has the potential to significantly impact the decision, treatment, and control of respiratory viruses worldwide,” said Douglas Bryant, COO of Luminex. “Abbott’s longstanding dedication to improve the quality of human health, combined with their global customer base, will make them a strong partner in bringing xTAG RVP to more physician, public health authorities, and patients around the world.” Financial terms were not disclosed. 

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