Cue Health Asks FDA for Full Clearance of Its Molecular COVID-19 Test

 Cue Health ("Cue") (Nasdaq: HLTH) today became the first company to submit to the U.S. Food and Drug Administration (FDA) for full clearance of its molecular COVID-19 test for at-home and point-of-care use. FDA clearance would provide the public with a molecular COVID-19 test that has been fully reviewed by the FDA for safety and effectiveness.

A prior submission to the FDA for Emergency Use Authorization of Cue's COVID-19 at-home, over-the-counter test showed 98.9% accuracy. An independent study by Mayo Clinic showed Cue's COVID-19 test to be in 97.8% overall concordance with central lab PCR testing.

"This FDA submission marks a major milestone for the company and begins to define a new space of molecular testing in the home and at the point-of-care. We hope this will be the first of many submissions for Cue's molecular testing as we look to address a range of diseases and conditions and make healthcare more responsive, convenient, and effective," said Ayub Khattak, CEO and co-founder of Cue Health.

https://finance.yahoo.com/news/cue-health-makes-novo-submission-130000144.html