Roche announces FDA authorization of the first EBV test for transplant patients

Aug. 7, 2020

Roche has announced that the U.S. Food and Drug Administration (FDA) has authorized the cobas Epstein-Barr virus (EBV) test, according to a press release from Roche. This is the first quantitative in vitro diagnostic test for Epstein-Barr virus DNA in the United States. This authorization 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.

“Monitoring of Epstein-Barr virus DNA can help prevent progression of life-threatening diseases, such as cancer in transplant patients,” said Thomas Schinecker, CEO of Roche Diagnostics. “The EBV test helps set a new standard of care for patients, as healthcare professionals now can act early in the management of this virus and can make more informed decisions when treating patients.”

The cobas EBV test is a polymerase chain reaction (PCR) viral load test that runs on the fully automated cobas 6800 and cobas 8800 systems. The test has been calibrated to the World Health Organization (WHO) International Standard. This means that test results are reported in international measures, making it possible for laboratories anywhere in the U.S. to obtain comparable results when measuring levels of EBV DNA.

The test was previously granted FDA Breakthrough Device designation, which enables an expedited review process for medical devices that provide improved treatment or diagnosis of life-threatening diseases or conditions.

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