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FDA Approves Roche HIV Viral Load Test

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has approved Roche's HIV viral load test, the Swiss drug and diagnostics firm announced today.

The test, called Cobas TaqMan HIV-1 Test, v2.0, will be available later this year and targets two highly conserved regions of the HIV-1 genome, avoiding any regions that are targeted by current drugs. As a result, the test provides increased reliability "even with rare mismatches in primer/probe binding sites and when mutations are present," Roche said.

The test uses the FDA-approved High Pure System Viral Nucleic Acid Kit for manual preparation and the Cobas TaqMan 48 Analyzer for automated amplification and detection. Since Roche its dual-target approach for monitoring HIV-1 patients on antiretroviral therapy in 2008, more than 8 million tests have been performed on Roche fully automated real-time PCR platforms, it said.

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