Research & Development
Roche granted US FDA Emergency Use Authorisation for Elecsys Anti-SARS-CoV-2 S antibody test
2 December 2020 -

Switzerland-based Roche (SIX: RO, ROG;OTCQX: RHHBY) has received Emergency Use Authorisation from the United States Food and Drug Administration (FDA) for its Elecsys Anti-SARS-CoV-2 S antibody test, it was reported on Tuesday.

The test can be utilised to measure the level of antibodies in people that have been exposed to the SARS-CoV-2 virus. It is aimed at antibodies that are directed against the region of the novel coronavirus known as the spike protein, specifically the area that allows the virus cell to bind to the host cell receptor, that is required for the virus to enter the host cell. It also offers a numerical result from 0.40-250 U/mL and a qualitative result. It runs on the company's widely available cobas e analysers.

The company is to start shipping the Elecsys Anti-SARS-CoV-2 S test to United States laboratories in the next week. The first lab to provide the testing option in the United States is LabCorp, an early adopter of the test with broad geographic reach.



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