FDA has issued 510K clearance for stabilized urine samples to be used with the cobas BKV Test on the cobas 6800/8800 Systems from Roche, Basel, Switzerland. This test, previously designated as a breakthrough device by the FDA and cleared for use with ethylenediaminetetraacetic acid (EDTA) plasma samples to aid in the management of BK virus (BKV) in transplant patients, now also delivers enhanced diagnosis of disease via noninvasive, 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 stabilized 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,” says Ann Costello, head of Roche Diagnostic Solutions. “With the FDA clearance of this noninvasive and easily collectable sample type, we now offer choices for clinicians using a standardized, 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.”
The cobas BKV Test runs on the widely available, high-throughput cobas 6800/8800 Systems. It is also approved for use in CE markets with EDTA plasma and urine stabilized in cobas PCR Media as sample types.
For more information, visit Roche.
Featured image: Roche cobas 6800.