The Department of Health and Human Services (HHS), in collaboration with the Department of Defense (DOD), awarded a $481 million contract to Cue Health to expand U.S. production capacity for a cartridge-based, point-of-care COVID-19 molecular test that delivers results in about 20 minutes, according to press releases.
The contract will allow Cue to expand its U.S.-based production capacity and deploy 6 million molecular, point-of-care (POC) Cue COVID-19 tests and 30,000 instruments by March 2021.
The Cue Health Monitoring System, San Diego-based Cue Health’s test, is comprised of a cartridge reader, test cartridge and sample wand, the FDA said. It is designed to be used with the Cue Health App on an iPhone 8 or newer mobile device. The test uses DNA/RNA amplification and immunoassay chemistry to detect the virus. Heating, mixing, amplification, and detection take place within the cartridge.
The U.S. Food and Drug Administration (FDA) granted an emergency use authorization (EUA) to Cue Health in June, authorizing the test for use in CLIA-certified labs that meet the requirements for high-, moderate- or waived-complexity tests, as well as at the point of care in healthcare settings that operate under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
In March, the Biomedical Advanced Research and Development Authority (BARDA) awarded Cue Health a $13 million contract to accelerate the development, validation and FDA clearance of this test.
