FDA grants Emergency Use Authorization to Roche’s Elecsys Anti-SARS-CoV-2 antibody test

The U.S. Food and Drug Administration has issued an Emergency Use Authorization for Roche’s new antibody test which identifies whether someone has been exposed to the SARS-CoV-2 virus and if they have developed antibodies against it. In addition to the US, countries accepting the CE mark will soon be in possession of the new test that can be run on Roche’s widely available cobas e analysers as the company dramatically increases production to satisfy demand.

Roche Diagnostics CEO, Thomas Schinecker, said: “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. Roche is committed to helping laboratories deliver fast, accurate, and reliable results to healthcare professionals and their patients.”

Roche Group CEO, Severin Schwan, said: “Thanks to the enormous efforts of our dedicated colleagues we are now able to deliver a high-quality antibody test in high quantities, so we can support healthcare systems around the world with an important tool to better manage the COVID-19 health crisis. I am particularly 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.”