Roche receives FDA approval for viral load tests and cobas 6800/8800 Systems

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The FINANCIAL — Roche announced on October 19 that it has received FDA approval for the cobas HBV and cobas HCV viral load tests, the first assays approved by the United States Food and Drug Administration (FDA) for use on the cobas 6800 and cobas 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. The new tests are the next generation of Roche’s viral load tests, which clinicians use to manage the treatment of patients chronically infected with hepatitis B or hepatitis C virus, according to Roche.

“These new systems will provide laboratories with solutions for routine molecular testing that offer excellent performance, unmatched flexibility and absolute automation,” said Roland Diggelmann, COO, Roche Diagnostics. “The cobas HBV and cobas HCV tests set new industry standards for viral load assays for the highly evolving hepatitis treatment regimens.”

In addition to the assays approved today, Roche currently has viral load tests under FDA review for HIV-1 and cytomegalovirus (CMV), which, when approved, will complete a comprehensive portfolio of viral load monitoring for the cobas 6800/8800 systems. Further menu expansion plans include qualitative tests for donor screening, women’s health and microbiology.


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