NEW YORK CITY (WABC) -- It could be a game changer in COVID 19 testing: A company with offices in the Tri-State area received emergency authorization from the FDA for a test that could get results ...

EVANSTON, Ill.--(BUSINESS WIRE)--Minute Molecular Diagnostics today announced that the U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for its rapid DASH ...

The FDA has issued its first emergency use authorization for a COVID-19 molecular diagnostic test that does not require a prescription and can be used at home. Developed by Cue Health, the Cue ...

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FDA-authorized test for home use is the most affordable PCR-quality rapid test on the market and at least 50 times more sensitive than leading rapid antigen tests Detect’s FDA authorized PCR-quality ...

Home diagnostics company Cue Health announced its received FDA de novo authorization for its at-home COVID-19 test, dubbed the Cue COVID-19 Molecular Test. The Cue COVID-19 Molecular Test detects ...

On 17 December 2025, the World Health Organization (WHO) announced the prequalification of two rapid antigen diagnostic tests ...

The U.S. Food and Drug Administration told consumers Monday to throw out any at-home COVID-19 tests made by San Diego biotech Cue Health, because they could give users false results. Early in the ...

San Diego-based medical tech company, Cue Health, bragged about receiving an industry-first De Novo authorization from the U.S. Food and Drug Administration (FDA) for its at-home COVID-19 test kit.

2025 update: This federal program has ended and free tests are not current available from the government website. Federal health officials have justified the millions they have spent on device ...

VIENNA (Reuters) - Swiss drugmaker Roche is unable to meet demand for molecular tests to identify active COVID-19 infections, its chairman told Swiss daily Tagesanzeiger. "The demand exceeds our ...