Test to detect the virus that causes the coronavirus (Covid-19) 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 coronavirus 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 Coronavirus symptoms and for those who live in affected areas.
The FDA’s EUA enables hospitals and reference laboratories to run the test on Roche’s fully automated Cobas 6800 and Cobas 8800 Systems to meet the urgent medical needs.
Roche Diagnostics CEO Thomas Schinecker said: “Providing quality, high-volume testing capabilities will allow us to respond effectively to what the World Health Organization has characterised as a pandemic. It is important to quickly and reliably detect whether a patient is infected with SARS-CoV-2.
“Over the last weeks, our emergency response teams have been working hard to bring this test to the patients. CE-mark certification and the FDA’s granting of EUA supports our commitment to give more patients access to reliable diagnostics which are crucial to combat this serious disease.”