ZURICH (Reuters) – Roche has received authorisation 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)
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