Cue Health has made a de novo submission to the U.S. Food and Drug Administration (FDA) for full clearance of the Cue Flu Molecular Test for at-home and point-of-care (POC) use. There are currently no flu tests on the market for home use. FDA clearance of Cue’s test would provide the public an at-home and POC molecular flu test that has been fully reviewed by the FDA for safety and effectiveness.
Clinical study results with the Cue Flu Molecular Test were favorable, demonstrating 99% accuracy1 compared to FDA cleared molecular (PCR) laboratory tests for influenza A&B. The Cue Flu Molecular Test cartridge uses a lower nasal swab and is compatible with the Cue Reader, which communicates test results digitally via Bluetooth to a mobile device in approximately 25 minutes.
“This FDA [de novo] submission for our Cue Flu Molecular Test is another important milestone on Cue’s path to pioneer a new approach to diagnostics in homes, enterprises, and healthcare settings,” said Ayub Khattak, Chairman and CEO of Cue Health. “Early detection and treatment can meaningfully improve health outcomes. There are multiple FDA-approved antiviral treatments for influenza available today, and we expect we will soon be able to promptly get these medications into the hands of patients who need them thanks to our recently launched Cue Care service.”
Cue’s molecular COVID-19 test, which is authorized by the FDA for home and POC use under an Emergency Use Authorization (EUA), is also currently under de novo submission review with the FDA. With an installed base of over a quarter million Cue Readers shipped to date, Cue’s COVID-19 test has been used by millions of Americans. Cue is used by some 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, the National Basketball Association, Bridgewater, among others.
DE NOVO SUBMISSION REFERENCE
1 With discordance analysis using a second FDA-cleared laboratory PCR test.