Quest Diagnostics launches AccuType IL28B test for HCV

Quest Diagnostics Incorporated (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, today announced the availability of its AccuType® IL28B test for aiding in the prediction of patient response to peginterferon alpha-based therapy for hepatitis C virus (HCV) infection. Quest Diagnostics is now offering the test to physicians and other healthcare providers in the U.S. and to pharmaceutical companies for use in clinical trials research.

The test was developed through a global non-exclusive license agreement under which Schering Corporation, a Merck affiliate, licensed certain patent rights claiming Interleukin (IL) 28B genetic markers to Quest Diagnostics. These genetic markers have been shown to provide an indicator of potential response to peginterferon alpha-based therapy for HCV. Additional terms were not disclosed.

"Our AccuType IL28B test will give physicians greater insights for treating individual patients infected with the most common form of HCV using standard antiviral therapies," said Rick L. Pesano, M.D., Ph.D., medical director, infectious diseases, Quest Diagnostics. "AccuType IL28B testing will also help physicians consider alternative therapies, which in the future may include HCV protease inhibitors."

Combination interferon-ribavirin therapy administered over several months is considered standard of care in treating HCV, although experimental HCV protease inhibitors are now under priority review by the U.S. Food and Drug Administration.  Side effects, such as fatigue, depression and nausea, affect the majority of patients, and an estimated 10% to 14% of people discontinue therapy. Moreover, as many as one in two patients fail to eradicate the virus, as indicated by blood tests, after a full course of therapy.

A certain polymorphism of the IL28B gene found in individuals infected with the most common type of HCV, HCV genotype 1, aids in identifying those patients who are twice as likely to eliminate the HCV virus on a sustained basis when treated with pegylated interferon-ribavirin combination therapies. Other factors, including age and gender, may affect treatment response.

HCV infection is the most common chronic blood borne infection in the United States, chronically infecting approximately 3.2 million people. Left untreated, chronic HCV can lead to liver cancer or liver cirrhosis requiring liver transplantation. Chronic HCV infection accounts for an estimated 8,000 to 10,000 deaths each year in the United States.

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