Roche, Basel, Switzerland, has received FDA approval for the Cobas 6800 and 8800 molecular testing systems, along with the first assays approved for use on them—the Cobas HBV and Cobas HCV viral load tests.
Aiming to introduce a new standard for routine molecular testing in the areas of viral load monitoring, donor screening, women’s health, and microbiology, the Cobas 6800 and 8800 are fully integrated and automated molecular testing systems designed to deliver full automation, increased throughput, and faster turnaround times. By offering the fastest time to results, the highest throughput, and the longest walkaway time available among automated molecular platforms, the systems seek to provide laboratories with improved operating efficiency and the flexibility to adapt to changing testing needs.
The systems provide up to 96 results in less than 3.5 hours and a total of 384 results for the Cobas 6800 and 960 results for the Cobas 8800 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 walkaway time with minimal user interaction.
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.
“These new systems will provide laboratories with solutions for routine molecular testing that offer excellent performance, unmatched flexibility, and absolute automation,” says Roland Diggelmann, chief operating officer at 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 recently approved assays, Roche currently has viral load tests under FDA review for HIV-1 and cytomegalovirus, which will complete a comprehensive portfolio of viral load monitoring assays for the Cobas 6800 and 8800 systems. Further menu expansion plans include qualitative tests for donor screening, women’s health, and microbiology.
For more information visit Roche.