FDA Clears Roche’s BK Virus Test

The FDA has granted Roche 510(k) clearance for its polymerase chain reaction (PCR) BK virus (BKV) quantitative test that runs on the company’s cobas 6800 and 8800 systems.

The BKV test, which previously earned a Breakthrough Device designation from the agency, is used to help assess risks for patients infected with the virus. It can cause serious complications related to solid-organ transplants and can occur without symptoms, according to the company.

The test “offers an alternative to lab-developed tests or analyte-specific reagent combinations, potentially minimizing variability and complexity in testing,” Roche said.