Roche Coronavirus test gets FDA approval

The Food and Drug Administration (FDA) has authorized the cobas SARS-CoV-2 test developed by Roche on an emergency use basis, as detailed in a press release issued by the Basel-based pharmaceutical company. The coronavirus test will therefore be available in all markets that accept the CE mark.

The Roche test will allow the number of tests to check whether a person has been infected with the coronavirus in the USA to be significantly increased. In remarks made by Donald Trump, the US President commented: “I want to thank Roche, a great company, for their incredible work”. This will allow an additional 1.4 million tests to be carried out in the near future, with an additional 5 million tests even possible within a month, Trump explained. In addition to praising Roche, the President also expressed thanks to Thermo Fisher.

In order to carry out the coronavirus tests developed by Roche, hospitals and laboratories require either of the cobas 6800 or cobas 8800 automated systems. These are widespread in the USA and around the world, according to Roche. The comprehensive testing capacities that are now available will allow rapid, effective reactions to combat this pandemic, explains Thomas Schinecker, CEO of Roche Diagnostics, in the press release. With cobas 6800/8800, a total of 96 tests can be analyzed within the space of three hours. Extra test stations increase this number further still. With cobas SARS-CoV-2, the results of the coronavirus tests are available within three-and-a-half hours, Roche states.