Roche Test That Measures Virus Antibody Levels Cleared in U.S.
(Bloomberg) -- A Roche Holding AG test that detects the presence and level of coronavirus antibodies inside people was cleared by the U.S. Food and Drug Administration for emergency use.
The test, known as the Elecsys Anti-SARS-CoV-2 S, identifies antibodies tied to the virus’s distinctive spike protein, a target for several of the leading vaccines in development. The test could be used to evaluate how well the shots work, including over time, Roche said in a statement announcing the approval.
Like other antibody tests, it could also be used to identify potential plasma donors. The use of so-called convalescent plasma to treat people hospitalized with Covid-19 was granted emergency authorization by the FDA earlier this year.
Similar tests from Siemens Healthineers AG, cleared by the FDA in late July, were the first such tests to get a green light in the U.S.
Roche will begin shipping the new antibody test to U.S. laboratories in the next week, where it will be processed using a Roche automated platform that produces results in about 18 minutes. Laboratory Corp of America Holdings will be the first to offer the tests.
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