The US Food and Drug Administration (FDA) has approved Emergency Use Authorization for market launch of the coronavirus antibody test developed by Roche. As of Monday, this will be distributed to labs and hospitals around the world, as detailed in a press release.
“Our best scientists have worked 24/7 over the last few weeks and months to develop a highly reliable antibody test to help fight this pandemic”, comments Thomas Schinecker, CEO of Roche Diagnostics, in the press release. According to information presented by Roche in the press release, the test boasts a specificity score of 99.8% and 100% sensitivity.
Severin Schwan, CEO of the Roche Group, was also quoted in the press release, stating: “I am in particular pleased about the high specificity and sensitivity of our test, which is crucial to support health care systems around the world with a reliable tool to better manage the COVID-19 health crisis”.
Roche has already started to distribute the tests to labs and hospitals around the world. Thanks to extensive, global production capacities, Roche will be in a position to supply the tests in high double-digit million quantities from May onwards, while capacities are also to be gradually expanded as well.