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.