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Roche BKV test FDA cleared on Cobas 6800/8800 systems

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“This FDA clearance allows Roche to offer health care 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,” Thomas Schinecker, CEO Roche Diagnostics, said in a press release.

The BKV test offers an alternative to lab-developed tests or analyte-specific reagent combinations, potentially minimizing variability and complexity in testing, reducing workload, and alleviating risk for laboratories.

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