Roche gets US nod for Covid-19 antibody test

ZURICH: Roche Holding AG received emergency-use authorisation from the US Food and Drug Administration for its new test determining if someone has been exposed to Covid-19, according to a statement on Sunday. The Basel-based drugmaker said it has already started shipments and that as of May, tens of millions of the antibody test will be available in the US and much of Europe.

Governments are trying to learn how many people have been exposed to the coronavirus as they wind down social-distancing measures. The restrictions on businesses have cost millions their jobs and the global economy is on course for its deepest dive since the Great Depression.

“Our best scientists have worked 24/7 over the last few weeks and months,” said Roche Diagnostics CEO Thomas Schinecker.


Hospitals and reference laboratories can run the Elecsys Anti-SARS-CoV-2 test on one of Roche’s analysis platforms, the company said. Roche’s antibody test has a specificity of more than 99.8% and 100% sensitivity, meaning that it not only reliably identifies patients who've developed antibodies but also can filter out those who haven’t, reducing misdiagnoses.