FDA grants EUA to Roche's Elecsys Anti-SARS-CoV-2


Roche recently announced that the U.S. Food and Drug Administration (FDA) had issued its antibody test, Elecsys Anti-SARS-CoV-2, Emergency Use Authorisation (EUA). The test helps identify if a patient has developed antibodies or has been previously exposed to SARS-CoV-2.

Roche has commenced the shipping of the antibody test to laboratories around the world and will significantly increase production capacity to millions per month, to serve the U.S. and countries who accept the C.E. mark.

“FDA grants EUA to Roche's Elecsys Anti-SARS-CoV-2.“

CEO Roche Group, Severin Schwan, stated: “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 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.”

CEO Roche Diagnostics, Thomas Schinecker, stated: “Our best scientists have worked twenty-four/ seven 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.”

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