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Lucira Health obtains FDA EUA for combined Covid-19 and Flu test

Lucira Health, Inc., a medical technology company, announced today that the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) for its Lucira Covid-19 & Flu Test, for point-of-care use. The Lucira Covid-19 & Flu Test is a molecular test that performed comparably to highly sensitive lab-based PCR assays in clinical trials. This combination test is the first in a pipeline of other multiple assay tests that leverage Lucira technology platform’s ability to multiplex from a single sample. The easy-to-use test delivers results between 11 and 30 minutes from one shallow nasal swab. The Lucira Covid-19 & Flu Test is available for use in CLIA-waived settings and can be purchased online at: www.lucirahealth.com, or email [email protected] for bulk orders.

“The Northern Hemisphere is already experiencing a challenging season due to the unprecedented co-circulation of Covid-19, flu and RSV. Covid-19 and flu viruses can both cause serious illness with similar symptoms, but each has unique prescription treatments that require diagnosis early in the infection to be effective. The inaccuracy of antigen Covid-19 tests makes such tests inadequate to use for early differential diagnosis of flu versus Covid-19. Clinicians can now facilitate simultaneous rapid testing at a mass scale to get patients on the path to recovery quickly,” said Erik Engelson, President and CEO of Lucira Health. “With this test and future testing capabilities, we aim to be at the forefront of quality, at-home health management.”
MB Bureau

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