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Cue Health Submits Flu Test to FDA for Regulatory Approval

NEW YORK – Cue Health announced on Thursday that it has made a de novo submission to the US Food and Drug Administration for its Cue Flu Molecular Test.

The submission is for both at-home and point-of-care use and the test is compatible with the Cue Reader, which communicates test results digitally via Bluetooth to a mobile device in approximately 25 minutes, the company said. The portable Cue Reader platform is also used for Cue's COVID-19 test, which is also under de novo review with the FDA, Cue noted in a statement.

The molecular influenza test performs nucleic acid amplification on a lower nasal swab sample. According to the company, clinical study results showed the test was 99 percent accurate compared to FDA-cleared PCR tests for influenza A/B.

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