Roche has received 510k clearance from the US Food and Drug Administration (FDA) for its cobas BKV Test on the cobas 6800 and 8800 Systems.
The test offers standardised, high-quality results to assist healthcare professionals in identifying complications caused by the BK virus in transplant patients and providing effective treatment options.
It uses dual-target technology that offers quantitative accuracy and prevents the risk of sequence variations that may be present in the BK virus.
Furthermore, the cobas BKV Test has robust coverage with a limit of detection of 21.5 IU/mL and an expanded linear range from 21.5 IU/mL to 1E+08 IU/mL in EDTA plasma.
It also provides an alternative to lab-developed tests (LDTs) or Analyte Specific Reagent (ASR) combinations, reducing the variability and complexity in testing while minimising workload and alleviating risk for laboratories.
The FDA previously granted breakthrough device designation to cobas BKV Test, indicating the improved treatment or diagnosis of life-threatening diseases or conditions for transplant patients.
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.”
BK virus, which belongs to the polyomavirus family, causes severe transplant-associated complications.
Infection can take place early in life and occur without symptoms. The virus can remain inactive after primary infection and reactivate later in immunocompromised individuals, including transplant recipients.
The cobas BKV Test runs on the fully automated and widely available cobas 6800 and cobas 8800 Systems.
Earlier this week, Roche received emergency use authorisation (EUA) from the US FDA for its cobas SARS-CoV-2 & Influenza A/B Test.