NEW YORK – Roche announced Wednesday its Cobas Epstein-Barr Virus test was authorized for use by the US Food and Drug Administration.
The quantitative test uses dual target technology to help clinicians monitor transplant patients who are at risk of complications from infections or reactivations of the virus. The PCR viral load test runs on Roche's Cobas 6800 and Cobas 8800 Systems and can be run simultaneously with other virology tests, the company said. It has been calibrated to the World Health Organization International Standard, meaning results are reported in international measures. The test's limit of detection is 18.8 IU per milliliter.
Roche's test previously received breakthrough device designation from the FDA and obtained CE marking last year.