FDA grants an EUA for Roche’s coronavirus test

Roche recently announced that the FDA has issued the cobas SARS-CoV-2 test an Emergency Use Authorisation. The test has been produced for the detection of the virus that causes the coronavirus, in oropharyngeal and nasopharyngeal swab samples, from patients who meet the requirements for testing. Hospitals will run tests on Roche’s cobas 8800 and 6800 systems, which provide results in 3 and a half hours.

Once authorization has been granted, Roche will have a few million tests available a month for use on its systems, by exceeding its production capacity limit.

Roche Diagnostics’ CEO, Thomas Schinecker, stated: “Providing quality, high volume testing capabilities will allow us to respond effectively to what the World Health Organization has characterized 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.”