Cue Health made a submission 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,” says Ayub Khattak, CEO and co-founder of Cue Health.
With an installed base of nearly a quarter million Cue Readers to date, Cue’s COVID-19 test has been used by millions of Americans. Cue is a COVID-19 testing solution in a number of the nation’s leading healthcare institutions, including Johns Hopkins Medicine, Mayo Clinic, Memorial Hermann, and UPMC Children’s Hospital of Pittsburgh. Cue is also used by world-class organizations such as Major League Baseball, Google, and the National Basketball Association.