FDA-approved test enables labs to combine manual specimen preparation, automated real-time PCR
INDIANAPOLIS, Oct. 3, 2012 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the U.S. availability of a new HIV-1 viral load test based on the company's proprietary dual-target approach. The COBAS TaqMan HIV-1 Test v2.0 for use with the High Pure System enables labs to combine an FDA-approved process for manual specimen preparation with an automated real-time PCR analyzer for amplification and detection.
"The availability of this new test will enable more labs, clinicians and patients to have access to Roche's innovative HIV technology," said Whitney Green, senior vice president, Molecular Diagnostics, for Roche Diagnostics Corporation. "The dual-target approach is helping to improve the ability of physicians to monitor viral load so they can effectively manage the treatment of people living with HIV."
Approved by the U.S. Food and Drug Administration (FDA) in July, the test utilizes the High Pure System Viral Nucleic Acid Kit for manual specimen preparation and the COBAS TaqMan 48 Analyzer for automated amplification and detection. It targets two highly conserved regions of the Human Immunodeficiency Virus (HIV)-1 genome and avoids any regions which are current drug targets, thus providing reliable test results even when mutations are present.
The addition of the HIV-1 Test v2.0 completes Roche's High Pure System offering, which also provides FDA-approved processes for manual specimen preparation for Hepatitis C and Hepatitis B testing via automated real-time PCR. With the approval of this test, labs can consolidate HIV-1 amplification and detection on the same platform (COBAS TaqMan 48 Analyzer) used for HCV and HBV viral load monitoring assays for use with the High Pure System.
About the dual-target test approach
Roche's dual-target strategy for HIV-1 viral load testing optimizes the quantification of HIV-1 subtypes by simultaneously detecting and amplifying two separate regions of the HIV-1 genome--thus providing built-in redundancy to minimize the effects of rare mismatches in primer/probe binding sites of a target region. In the face of the rapidly growing genetic diversity of HIV-1 and its implications for the efficacy of antiretroviral therapy, this approach ensures enhanced reliability of results. Since Roche first introduced this innovative dual-target approach for monitoring HIV-1 patients on antiretroviral therapy in 2008, more than eight million tests have been performed worldwide.
According to the Centers for Disease Control and Prevention (CDC), an estimated 1.2 million persons were living with HIV infection in the United States at the end of 2010. Of those, 20% had undiagnosed HIV infections. Highly active antiretroviral treatment (HAART) and viral load tests that determine the amount of circulating HIV have contributed to a profound increase in life expectancy for people living with HIV.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com or www.roche-diagnostics.us.
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