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Roche announces FDA authorisation for the first Epstein-Barr virus quantitative test on the cobas 6800/8800 Systems to improve care for transplant patients

Written by Customer Service on . Posted in Public Companies.

FDA granted de novo class II for cobas EBV test following the agency’s Breakthrough Device designationAccurate monitoring of Epstein-Barr virus DNA levels is critical, as they are  associated with a range of life threatening-diseases including cancer in transplant patientsTest meets World Health Organization standards for consistent result reporting among laboratories across the U.S., allowing for results to be easily comparable across hospitals and labsBasel, 5 August 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has authorised the cobas® EBV test. This is the first quantitative in vitro diagnostic test for Epstein-Barr virus (EBV) DNA in the United States. This authorisation gives healthcare professionals a key tool in monitoring transplant patients at risk for complications from infections or reactivations of EBV, by providing the ability to run a large number of patient tests for this virus in a short period of time. Attachment05082020_MR_EBV

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