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 that were being pushed now, according to a report from Reuters. He called the tests a ‘disaster’ and questioned the ethics of some of the test makers, according to the Reuters article.

Roche’s EUA comes during a turning point of sorts in the fight against COVID-19. Late last week, FDA granted EUA to Gilead Sciences’ remedesivir drug. Preliminary results from the Foster City, CA-based drugmaker’s study were favorable. The drug also performed well in a study from the National Institute of Allergy and Infectious Diseases.

Gilead has said it will donate its entire supply of the drug to the U.S. government.

Both developments come as there are nearly 3.6 million coronavirus cases worldwide with about 249,000 deaths and 1,2 million recovering, according to statistics from worldometers.info.