The U.S. Food and Drug Administration has granted Roche an emergency use authorization (EUA) for Elecsys Anti-SARS-CoV-2 S test, according to Roche’s press release. The test will gauge an individual’s antibody response to coronavirus vaccines that could soon become available.
- Roche’s tests will provide numerical results showing the concentration of antibodies and a qualitative result as a way to measure the “vaccine-induced immune responses.”
- Clinical laboratories can run antibody tests on their own analytical units and receive results in about 18 minutes, with a test throughput of up to 300 tests per hour.
- Roche’s test approval comes amid progress towards a mass rollout of vaccines from Pfizer, BioNTech, Moderna, and AstraZeneca.
- On Wednesday, the U.K became the first country in the world to approve Pfizer and BioNTech vaccine for use.
Roche’s stock is currently gaining. RO: SWX is up 0.40%
