The test helps healthcare professionals and patients to better manage transplantation infections due to BK polyomavirus
Transplant monitoring test for BK virus. (Credit: Roche.)
Roche has secured the US Food and Drug Administration (FDA) 510K approval for use of stabilised urine samples with its cobas BKV Test, run on the cobas 6800/8800 Systems.
The test was previously granted FDA Breakthrough Device and was approved for use with ethylenediaminetetraacetic acid (EDTA) plasma samples, for the management of BK virus (BKV) in transplant patients.
With the non-invasive, easily collected, prepared and stored urine samples, the test would enhance the diagnosis of disease, said the company.
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.”
Roche designed cobas BKV Test with dual-target technology
BK polyomavirus (BKV) causes transplant-associated complications including nephropathy in kidney transplantation and hemorrhagic cystitis in hematopoietic stem cell transplantation.
Considered as the most common viral complication in kidney transplant patients, BKV infection may cause polyomavirus nephropathy (PVN), which leads to transplant graft failure.
Elevated levels of BKV DNA present in urine, prior to plasma serves as an early predictor of an impending infection.
The Swiss drug maker said that its cobas BKV Test is a real-time PCR test that runs on the widely available, high-throughput cobas 6800/8800 Systems.
Fully automated cobas 6800/8800 Systems are said to provide fastest time to results, highest throughput and the longest walk-away time.
With dual-target technology, the test provides quantitative accuracy and protection against the risk of sequence variations associated with the BK virus.
Roche said that a urine sample stabilised in cobas PCR Media facilitates the easy storage and transportation of sample, without needing refrigeration.
As an alternative to lab-developed tests (LDTs) or Analyte Specific Reagent (ASR) combinations, the test minimises the variability and complexity in testing, reduces workload and eliminates risk for laboratories.