Roche Gets FDA Approval for Cobas MDx Systems; HBV, HCV Viral Load Tests

Roche has received approval from the US Food and Drug Administration for its Cobas 6800 and Cobas 8800 molecular diagnostic platforms and associated hepatitis B and hepatitis C viral load assays.

The assays are the first approved by the FDA for use on the Cobas 6800 and 8800. These medium- and high-throughput PCR systems were unveiled in 2013, and allow for rapid, automated, mixed-batch processing.

Cobas HBV, a real-time PCR test for HBV genotypes A through H, was CE-marked in May. The Cobas HCV assay employs the firm's dual-probe approach to detect hepatitis C RNA and was CE-marked last December.

Roche noted in a statement that it currently has viral load tests under FDA review for HIV-1 and cytomegalovirus. When approved, these will complete a portfolio of viral load monitoring for the Cobas 6800/8800 systems, with further menu expansion plans including qualitative tests for donor screening, women's health, and microbiology.