SOUTH SAN FRANCISCO (dpa-AFX) - Swiss drugmaker Roche (RHHBY) Monday said it has received FDA approval for the cobas HIV-1 viral load test by the United States Food and Drug Administration for use on the cobas 6800 and cobas 8800 Systems.
This HIV-1 viral load test is part of the next generation of Roche viral load tests, which clinicians use to manage the disease and treatment of patients infected with HIV-1.
'The cobas® HIV-1 test is based on Roche's unique dual-target technology to simultaneously amplify and detect two separate regions of the HIV-1 genome, which are not subject to selective drug pressure,' said Paul Brown, Head of Roche Molecular Diagnostics.
The addition of this test on the fully automated cobas 6800/8800 Systems provides laboratories with a comprehensive virology menu to support physicians in making informed treatment decisions for HIV-1 patients undergoing antiretroviral therapy, Brown added.
In addition to the new HIV-1 assay, Roche offers the FDA-approved cobas HBV and cobas HCV viral load tests on the cobas 6800/8800 Systems.
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