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Roche: FDA grants emergency authorization for Covid self-tes

(CercleFinance.com) - Roche announced on Friday evening that the FDA has granted emergency use authorization (EUA) for its Covid-19 home test, which will be available throughout the United States as from January, in accordance with local guidelines and screening strategies.


The Swiss company says that the self-test, which uses a simple nasal swab sample, is capable of producing accurate, reliable results within 20 minutes for SARS-CoV-2 and all known variants of concern, including Omicron.

Roche has the capacity to produce tens of millions of tests per month in response to the pandemic. The launch will be made in partnership with SD Biosensor, with which it has a global distribution agreement.


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