Roche has secured the US Food and Drug Administration (FDA) 510k approval to perform cobas BKV test on the company’s fully automated cobas 6800 and 8800 systems.
The US regulatory agency has previously granted Breakthrough Device designation for the test, establishing its capability to deliver enhanced diagnosis of diseases for transplant patients.
The Swiss healthcare company said that its new diagnostic test provides standardised results to facilitate the assessment of complications caused by the BK virus in transplant patients and identify better treatment options.
Roche Diagnostics CEO Thomas Schinecker said: “Our diagnostic tests can help clinicians greatly improve patient treatment plans and make quick adjustments for personalised healthcare.
“This FDA clearance allows Roche to offer healthcare professionals a transplant testing portfolio that includes Cytomegalovirus, Epstein-Barr virus and BK virus so they can simultaneously monitor and improve care for transplant patients who are at risk for these common infections or viral reactivations which can cause further illness or death.”
The cobas BKV Test is a polymerase chain reaction (PCR) viral load test
BK polyomavirus (BKV) is a member of the polyomavirus family that can cause transplant-associated complications including nephropathy in kidney transplantation and hemorrhagic cystitis in hematopoietic stem cell transplantation.
The cobas BKV test is a polymerase chain reaction (PCR) viral load test, designed to work on the cobas 6800 and cobas 8800 Systems, which provide up to 96 results in about three hours.
The test leverages dual-target technology to provide accuracy and protection against the risk of sequence variations in the BK virus.
The cobas BKV test is said to provide an alternative to lab-developed tests (LDTs) or Analyte Specific Reagent (ASR) combinations, to reduce the variability and complexity in testing, reducing workload and alleviating risk for laboratories.
The company said that together with its previously approved cobas EBV and CMV Tests, the new cobas BKV Test has been calibrated to the World Health Organization (WHO) international standard, indicating that the test results are reported in international units.
