(CercleFinance.com) – Roche announced Friday evening that the FDA has granted Emergency Use Clearance (EUA) for its Covid-19 home test, which will be available across the United States from January, in accordance with local screening guidelines and strategies.
The Swiss group explains that this self-test using a simple nasal swab sample is able to produce accurately, reliable results in 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 to help support the pandemic response. The launch will be done in partnership with SD Biosensor, with whom it has entered into a worldwide distribution agreement.
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