The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Roche’s Cobas SARS-CoV-2 Test to detect the virus that causes the coronavirus (Covid-19).
The test is for the qualitative detection of the virus SARS-CoV-2 in nasopharyngeal or oropharyngeal swab samples from patients who meet Covid-19 clinical or epidemiological testing criteria.
Roche is also offering the CE-IVD test in markets accepting CE mark approval. The test is for patients with Covid-19 symptoms and for those who live in affected areas.
