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FDA clears Roche’s BK virus quantitative test for transplant patients

September 9, 2020


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.