Celltrion has nabbed a speedy preapproval for its quick pandemic virus test as it forecasts high demand.
This comes three months after asking the FDA for an emergency use authorization, which has been giving COVID-19 tests and drugs the ability to be used in the U.S. but is not a full approval.
RELATED: Celltrion passes early safety trial for anti-COVID-19 antibody as key tests await
Celltrion, better known for its drug biosimilars but now also working on an COVID-19 antibody, said in a statement that it “believes the demand for rapid diagnosis kits will be high, mainly among large businesses and government agencies that are about to return to work after telecommuting.”
It has named the test Sampinute; it can deliver results within 10 minutes and has, according to the South Korean company, a 94% sensitivity rate. Shares in the company jumped nearly 5% on the news Monday morning.
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October 26, 2020 at 06:55PM
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Celltrion nabs emergency use for rapid COVID-19 test from FDA - FierceBiotech
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