Roche Scores EUA for COVID-19 Antibody Test

There were some pretty significant developments in the world of COVID-19 that occurred over the weekend. One of these developments was Roche Diagnostics being granted Emergency Use Authorization (EUA) for the Elecsys Anti-SARS-CoV-2 antibody test. The antibody or serology test is designed to help determine if a patient has been exposed to the SARS-CoV-2 virus and if the patient has developed antibodies against SARS-CoV-2. Roche said it has already started shipping the new antibody test to laboratories worldwide and will ramp up production capacity to high double-digit millions per month to serve healthcare systems in countries accepting the CE mark as well as the U.S. “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,” Thomas Schinecker, CEO Roche Diagnostics, said in a release. “Roche is committed to helping laboratories deliver fast, accurate, and reliable results to healthcare professionals and their patients.” Roche was one of the initial companies to obtain EUA for a COVID-19 detection test, which differs from the antibody test. In March, FDA said it granted the authorization for the COVID-19 test after 24 hours of receiving Roche’s application. Nearly two weeks ago, Roche Holding Group’s CEO, Severin Schwan was highly critical of many of the antibody tests tha...
Source: MDDI - Category: Medical Devices Tags: COVID-19 IVD Source Type: news