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Cue Health Awarded $13M BARDA Contract for POC Coronavirus Test

NEW YORK – The US Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) has awarded Cue Health a contract for $13 million to develop, validate, and obtain US regulatory clearance for a rapid molecular diagnostic test to detect SARS-CoV-2, the virus that causes COVID-19, the company said Tuesday.

The test is part of the Cue Health Monitoring System, a portable device that connects patients to a mobile health platform consisting of interventional components such as telemedicine consultations, the firm said.

BARDA funding will support scale-up of the molecular COVID-19 test, which uses nasal swabs to enable rapid results, San Diego-based Cue Health said.

"We have worked with the BARDA team for the past two years developing and testing a 20-minute, molecular influenza test designed for home and point-of-care use," Cue Health CEO Ayub Khattak said in a statement. "Rather than waiting days for results or sending samples off to a lab, having test results in 25 minutes could drastically improve our ability to contain the spread of the virus for this and future pandemics.”

Distribution of the Cue platform may allow regular screening by professionals and eventually lead to testing at home and in the community, Khattak said.

The firm said it anticipates equipping clinics, schools, eldercare facilities, and homes with affordable tests. In the case of a viral or other biothreat, availability of such a test could enable monitoring of a global, connected network that produces real-time epidemiological data, it said.

Its molecular system uses a portable reader system to test clinical samples in a disposable test cartridge that, according to Cue, uses advanced DNA/RNA amplification and immunoassay chemistry to generate digital information.

In 2018, Cue had announced a BARDA contract of up to $30 million to accelerate the development and regulatory validation of over-the-counter and professional-use influenza and multiplex respiratory pathogen diagnostic cartridges for its health monitoring system.