Quest Diagnostics has launched their own IL28B test called AccuType to compete with LabCorp's IL28B assay. As discussed before, I've talked with several physicians who felt that the assay is helpful, but may not be clinically relevant enough to make the decision to treat or not to treat, despite the data to back the assay. They've had enough T/T's succeed in achieving SVR and enough C/C's fail therapy to know that the IL28B polymorphism is an important factor in achieving an SVR, but certainly not the only one. In the words of one physician, "RVR trumps all". I've also talked with several who buy into the importance of the assay in making treatment decisions. I reckon the market will decide for us.
AccuType® IL28B test now available to physicians and for clinical trials research
MADISON, N.J., April 18, 2011 /PRNewswire/ -- 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.(1),(2) Side effects, such as fatigue, depression and nausea, affect the majority of patients, and an estimated 10% to 14% of people discontinue therapy.(3),(4) Moreover, as many as one in two patients fail to eradicate the virus, as indicated by blood tests, after a full course of therapy.(5)
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.(6) 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.(7)
About Quest Diagnostics
Quest Diagnostics is the world's leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care.
Quest Diagnostics' broad hepatitis C and B virus testing menu includes hepatic function tests to help determine HCV exposure and identify abnormal liver function; Heptimax® viral RNA quantitative testing to monitor viral load during therapy; and HCV genotyping to aid in predicting treatment duration and success. Quest Diagnostics also offers tests, such as HepaScore™, to help physicians identify and stage liver fibrosis.
Additional company information is available at www.QuestDiagnostics.com.
Quest, Quest Diagnostics, the associated logo, Nichols Institute and all associated Quest Diagnostics marks are the registered trademarks of Quest Diagnostics. All third party marks — ®' and ™' — are the property of their respective owners. © 2000-2011 Quest Diagnostics Incorporated. All rights reserved.
(1) Merck press release, 1/6/11; Vertex Pharmaceuticals press release; 1/20/11.
(2) HCSP Fact Sheet, Hepatitis C Support Project (HCSP);2008;ver 3.
(3) Lancet 2001; 358:958-965.
(4) N Engl J Med 2002; 347:975-982.
(5) HCSP Fact Sheet, Hepatitis C Support Project (HCSP),ver 3, 12/08.
(6) "Nature, 2009;10.1038;1-3.
(7) Hepatitis C FAQs for Health Professionals, U.S. Centers for Disease Control and Prevention Source, updated 12/17/10.
Quest Diagnostics Contacts:
Wendy Bost (Media): 973-520-2800
Kathleen Valentine (Investors): 973-520-2900
SOURCE Quest Diagnostics Incorporated
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