NEW YORK – Roche announced Tuesday its Cobas test for BK virus has received 510(k) clearance from the US Food and Drug Administration to run on the firm's Cobas 6800 and 8800 Systems.
The RT-PCR test previously received breakthrough device designation and provides standardized results to help clinicians determine the risk of complications resulting from the BK virus in transplant patients. The polyomavirus "can cause severe transplant-associated complications" and can occur without symptoms, remaining inactive after the primary infection and reactivating in immunocompromised patients, the company said in a statement. It can also cause nephropathy in kidney transplants and hemorrhagic cystitis in hematopoietic stem cell transplants.
Roche's test has been calibrated to the World Health Organization International Standard, with results reported in international units. It uses dual-target technology and has a limit of detection of 21.5 international units per milliliter.
The BKV test joins Roche's portfolio of transplant tests, which also includes assays for cytomegalovirus and Epstein-Barr virus, all of which can run simultaneously on the Cobas 6800 and 8800 systems.