Roche has received the US Food and Drug Administration (FDA) 510K clearance for Cobas BKV Test for use with stabilised urine samples.
The Cobas BKV Test runs on the Cobas 6800/8800 Systems.
It is a real-time polymerase chain reaction (PCR) test with dual-target technology that offers quantitative accuracy and protects against the risk of possible sequence variations present in the BK virus.
The test offers an alternative to lab-developed tests (LDTs) or analyte-specific reagent (ASR) combinations, reducing variability and complexity in testing, as well as workload and risk alleviation for labs.
Earlier, the test had received a breakthrough device designation from the FDA and was cleared for use with ethylenediaminetetraacetic acid (EDTA) plasma samples to help in managing BKV in transplant patients.
With the latest development, the test offers enhanced diagnosis of disease through non-invasive, easily collected, prepared, and stored urine samples.
BKV can cause severe complications in immunocompromised transplant patients.
The company noted that increased BKV DNA levels can be found in urine prior to plasma and could serve as an early predictor of an impending infection.
A urine sample stabilised in cobas PCR Media enables maintenance of urine result integrity, simplifying storage and transportation without needing refrigeration of the sample.
Roche Diagnostic Solutions head Ann Costello said: “Transplant patients face a number of significant challenges, including complications that can arise from viruses like BKV.
“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.”
Earlier, the FDA granted breakthrough device designation to Roche’s Elecsys GDF-15 assay as a companion diagnostic (CDx) in cancer treatment.