(RTTNews) - Roche (RHHBY) announced FDA 510k clearance for the cobas BKV Test on the cobas 6800 and 8800 Systems. The cobas BKV Test is a polymerase chain reaction viral load test that runs on the fully automated cobas 6800 and cobas 8800 Systems. The cobas BKV Test was previously granted Breakthrough Device Designation by the FDA.
"This FDA clearance allows Roche to offer healthcare professionals a transplant testing portfolio that includes Cytomegalovirus, Epstein-Barr virus and BK virus so they can simultaneously monitor and improve care for transplant patients who are at risk for these common infections or viral reactivations which can cause further illness or death," said Thomas Schinecker, CEO Roche Diagnostics.
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