Roche Receives FDA Approval for HIV-1 Viral Load Test on the cobas 6800/8800 Systems

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Roche Receives FDA Approval for HIV-1 Viral Load Test on the cobas 6800/8800 Systems

fda-logoRoche has received 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.

About the cobas 6800/8800 Systems: The cobas 6800 and cobas 8800 Systems are fully integrated, automated solutions that introduce a new standard for routine molecular testing in the areas of donor screening, viral load monitoring, women’s health and microbiology. Based on Nobel-prize winning PCR technology, the systems are designed to deliver full automation, increased throughput and faster turnaround time, providing users with greater flexibility to increase overall workflow efficiencies.

The systems provide up to 96 results in less than 3.5 hours, and a total of 384 results for the cobas 6800 System and 960 results for the cobas 8800 System in an 8-hour shift. Both make it possible for labs to perform up to three tests in the same run with no presorting required. The systems also enable up to 8 hours (cobas 6800) and 4 hours (cobas 8800) of walk-away time with minimal user interaction. For more information about the systems, please visit or