Roche announces FDA authorisation for the first Epstein-Barr virus quantitative test on the cobas 6800/8800 Systems to improve care for transplant patients
- FDA granted de novo class II for cobas EBV test following the agency?s Breakthrough Device designation
- Accurate monitoring of Epstein-Barr virus DNA levels is critical, as they are? associated with a range of life threatening-diseases including cancer in transplant patients
- Test 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 labs
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