Roche's cobas HIV-1 viral load test approved by FDA for use on cobas 6800 and cobas 8800 Systems

Dec 21 2015

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received FDA approval for the cobas® HIV-1 viral load test by the United States Food and Drug Administration (FDA) 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."

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. The fully automated systems offer the fastest time to results, the highest throughput and the longest walk-away time available among automated molecular platforms, providing laboratories both improved operating efficiency and flexibility to adapt to changing testing needs. Further menu expansion plans include a viral load test for cytomegalovirus (CMV) and qualitative tests for donor screening, women's health and microbiology.