Roche Receives FDA Clearance For Urine Sample Type For BK Virus Quantitative Test

(RTTNews) - Roche Thursday announced the U.S. Food and Drug Administration 510K clearance of stabilised urine samples to be used with the cobas BKV Test on the cobas 6800/8800 Systems.

This test, previously designated as a Breakthrough Device by the FDA and cleared for use with ethylenediaminetetraacetic acid plasma samples to aid in the management of BK virus in transplant patients, now also delivers enhanced diagnosis of disease via non-invasive, easily collected, prepared and stored urine samples.

BKV can cause severe complications in immunocompromised transplant patients. Higher BKV DNA levels can often be present in urine prior to plasma, serving as an early predictor of an impending infection. A urine sample stabilised in cobas PCR Media allows the integrity of urine results to be maintained, making storage and transportation simpler without the need for sample refrigeration.

"Transplant patients face a number of significant challenges, including complications that can arise from viruses like BKV," said Ann Costello, Head Roche Diagnostic Solutions. "With the FDA clearance of this non-invasive and easily collectable sample type, we now offer choices for clinicians using a standardised, automated solution to routinely monitor and manage infection risks. Together with our viral load tests for Cytomegalovirus and Epstein-Barr virus, we are committed to bringing better care to transplant patients."