The U.S. Food and Drug Administration (FDA) granted an emergency use authorization (EUA) to Cue Health for a point-of-care (POC) test to detect SARS-CoV-2 from nasal specimens, according to the FDA’s website.
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 FDA said.
The FDA’s EUA authorizes 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. BARDA is a part of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services.
According to Cue Health, the company also is completing the validation needed for FDA submission of its portable system for at-home influenza A and B testing.
