Cue Health Becomes First Company to Receive FDA De Novo Authorization COVID-19 Home Use Test
Portfolio Pulse from Vandana Singh
Cue Health Inc (NASDAQ:HLTH) has become the first company to receive FDA De Novo authorization for its Cue COVID-19 Molecular Test, designed for home and point-of-care use. The test has a 98% accuracy rate and delivers results in 20 minutes. The company has also submitted a De Novo for its Cue RSV Molecular Test for at-home and point-of-care use.
June 07, 2023 | 12:54 pm
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Cue Health receives FDA De Novo authorization for its COVID-19 home test, making it the first company to achieve this milestone. The test has a 98% accuracy rate and delivers results in 20 minutes.
Cue Health's FDA De Novo authorization for its COVID-19 home test is a significant milestone for the company, as it is the first to achieve this. The test's high accuracy rate and quick results delivery make it an attractive option for consumers, which could lead to increased demand and a positive impact on the company's stock price in the short term.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100