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.
Reporting by John Revill; Editing by Kim Coghill