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 it could give users false results. Early in the pandemic, the FDA gave Cue Health the industry’s first emergency use authorization, a fast-track approval, for its sleek, 15-minute molecular COVID-19 test. Last year, the San Diego-based company also became the first at-home coronavirus test to receive full regular-use clearance.
” Cue Health issued a statement Monday evening that said it has received the FDA warning letter and is “currently evaluating the letter and determining its response, with more information to follow in the next few days.” The company did not respond to the Union-Tribune’s request for comment on Tuesday. During the coronavirus pandemic, Cue was a major beneficiary of the government’s multi-million dollar push to fund rapid testing, especially with home test kits.
Source: Healthcare Press (healthcarepress.net)
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