FDA approves the Cobas TaqMan HIV-1 Test (Roche)

The FDA has approved the Cobas TaqMan HIV-1 Test, from Roche, which will be available in the US later this year. The test utilizes the FDA-approved High Pure System Viral Nucleic Acid Kit for manual specimen preparation and the COBAS TaqMan 48 Analyzer for automated amplification and detection. This one targets two highly conserved regions of the HIV-1 genome and avoids any regions which are current drug targets, thus providing increased reliability as compared to other single target assays should a mutation occur. The test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in plasma HIV-1 RNA levels during the course of antiretroviral treatment.