Roche has received 510k clearance from the US Food and Drug Administration (FDA) for its cobas BKV Test on the cobas 6800 and 8800 Systems.
The test offers standardised, high-quality results to assist healthcare professionals in identifying complications caused by the BK virus in transplant patients and providing effective treatment options.
It uses dual-target technology that offers quantitative accuracy and prevents the risk of sequence variations that may be present in the BK virus.
Furthermore, the cobas BKV Test has robust coverage with a limit of detection of 21.5 IU/mL and an expanded linear range from 21.5 IU/mL to 1E+08 IU/mL in EDTA plasma.
