FDA clears Roche Epstein-Barr virus test for transplant patients

FILE PHOTO: General view of the Roche building in Welwyn Garden City, following the outbreak of the coronavirus disease (COVID-19), Welwyn Garden City, Britain, May 14, 2020. REUTERS/Paul Childs

Roche gets FDA okay for transplant patients Epstein-Barr virus test

ZURICH (Reuters) – Roche has received authorization from the United States’ Food and Drug Administration (FDA) for its cobas 6800/8800 diagnostic tests for transplant patients, the company said on Wednesday.

The tests are used to detect Epstein-Barr virus DNA levels, linked to a range of diseases including cancer. The tests had previously been granted a breakthrough device designation by the FDA.