FDA clears Roche’s BK virus quantitative test of cobas systems

Roche has secured US approval for the cobas BKV Test on the cobas 6800 and 8800 Systems to support better care for transplant patients.

The test was previously granted FDA Breakthrough Device designation demonstrating the improved treatment or diagnosis of life-threatening diseases or conditions for transplant patients.

The test provides standardised, high-quality results that can help healthcare professionals better assess the risk of complications caused by the BK virus in transplant patients and identify effective treatment options.

BK virus (BKV) is a member of the polyomavirus family that can cause severe transplant-associated complications.

Infection can occur without symptoms and happen early in life. After primary infection, the virus can remain inactive, only to possibly reactivate in immunocompromised individuals such as transplant recipients.

“Our diagnostic tests can help clinicians greatly improve patient treatment plans and make quick adjustments for personalised healthcare,” said Thomas Schinecker, CEO of Roche Diagnostics.

“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.”

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