The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to Roche for its Elecsys Anti-SARS-CoV-2, or COVID-19, antibody test.
The test is designed to help determine if a patient has been exposed to the virus and if the patient has developed antibodies against SARS-CoV-2. Roche, which has already started shipping the test to leading laboratories, will ramp up production capacity to send out high double-digit millions per month to hospitals around the world.
“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,” Severin Schwan, CEO Roche Group, said. ”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’s SARS-CoV2 antibody test can help assess patients’ immune response to the virus. It could help to evaluate who has built up immunity to the virus.
“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. “Roche is committed to helping laboratories deliver fast, accurate, and reliable results to healthcare professionals and their patients.”
Hospitals and reference laboratories can run the test on Roche’s cobas e analysers, which are widely available around the world.