Test with enhanced reliability for monitoring HIV patients now CE marked
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received CE mark for the expanded use of its novel HIV test.1 This allows the test to be used in smaller laboratory settings. In the face of the rapidly growing genetic diversity of HIV-12,3 and its implications for the efficacy of antiretroviral therapy, Roche’s new dual target approach ensures enhanced reliability of test results and more confidence in assessing viral loads. Since Roche introduced this innovative strategy in 2008, over 3.2 million tests have been performed using the dual target approach for monitoring HIV patients on antiretroviral therapy.
“This dual target approach improves the ability of physicians and laboratories to obtain reliable information about HIV-infected patients,” said Paul Brown, PhD, Head of Roche Molecular Systems. “Roche is committed to developing and providing new diagnostic tools such as this dual target approach that will better serve all laboratories performing viral load tests for HIV patients, including laboratories performing clinical trial and research-related studies that have specific needs.”
The dual target strategy
The dual target strategy improves accuracy in quantifying HIV-1 subtypes by avoiding the effects of rare mismatches in primer/probe binding sites of a target region by simultaneously detecting and amplifying 2 separate regions of the HIV-1 genome. 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.
Accordingly to UNAIDS, there were 33.3 million people living with HIV around the world in 2009. In that same year, 2.6 million people became newly infected with HIV— almost 20 percent fewer than in the late 1990s.4 Highly active antiretroviral treatment (HAART) and viral load tests, a test to determine the amount of circulating HIV, have contributed to a steady increase in life expectancy for HIV-infected people by 13 years.5
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 personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80’000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 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.
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For further information please contact:
Roche Molecular Systems, +1 888-545-2443
- COBAS® TaqMan® HIV-1 Test, v2.0 For Use With The High Pure System
- Clark SA, Calef C, Mellors JW. Mutations in retroviral genes associated with drug resistance. HIV sequence database. http://www.hiv.lanl.gov/content/sequence/HIV/REVIEWS/2006_7/RESISTANCE/Resist.html. Accessed August 29, 2008.
- Chequer-Fernandez SL, Rodrigues CA, Campos-Melo DL, Pilotto JH, Morgado MG. HIV-1 polymorphism: evaluation of its potential implication for the response to antiretroviral therapy of HIV-1 infected patients with prevalent subtypes in Rio de Janeiro, Brazil [abstract]. Presented at: 15th International AIDS Conference; July 11-16, 2004; Bangkok, Thailand. Abstract MoPeC3442. http://gateway.nlm.nih.gov/MeetingAbstracts/ma?f=102279743.html. Accessed August 19, 2008.
- The UNAIDS Report on the Global AIDS Epidemic 2010.
- Lancet. Volume 372, Issue 9635, 26 July 2008-1 August 2008, Pages 293-299