The FDA today issued its first emergency use authorization for a molecular COVID-19 diagnostic test for at-home use without a prescription.
The Cue Health COVID-19 Test for Home and Over The Counter (OTC) use is a molecular nucleic acid amplification test designed to detect genetic material from the SARS-CoV-2 virus in the nostrils.
The authorized test includes a single-use Cue COVID-19 test cartridge, a single-use nasal swab and the Cue cartridge reader (used by the Cue Health monitoring system, provided separately). The reusable, battery-operated cartridge reader runs the Cue test cartridge and communicates results directly to the customer’s Cue Health smartphone app in about 20 minutes. The mobile app requires individuals to create an account, and in the future will able to report test results as appropriate to public health authorities to monitor disease prevalence, according to the FDA.
The test correctly identified 96% of positive samples from individuals known to have symptoms and correctly identified 100% of positive samples from individuals without symptoms, the agency noted. Cue Health expects to produce more than 100,000 tests per day by summer 2021 but has not determined pricing yet.
“For the first time, consumers can access laboratory-grade testing at home. This is an important milestone in the advancement of COVID-19 testing,” said Cue CEO Ayub Khattak in a news release. “With this FDA authorization, we are one step closer to achieving our mission of making molecular diagnostic testing available to anyone, anywhere, at any time through a connected healthcare delivery ecosystem. Our guiding principle has been to revolutionize diagnostics to transform health outcomes, and we are so proud to lead this transformative paradigm shift in the U.S. healthcare system.”
“The authorization of this new diagnostic test underscores FDA’s goal to continue supporting innovation in testing and providing flexibility to test developers with the aim of increasing the availability of accurate and reliable tests for all Americans,” added acting FDA commissioner Janet Woodcock in a separate news release. “The FDA will continue to expand Americans’ access to testing to help us in the fight against this pandemic, which has claimed over half a million lives.”
The Cue COVID-19 test received an EUA from the FDA in June 2020 for use in clinical and point-of-care settings. The tests are currently being used in the U.S. in K-12 schools, essential businesses, nursing homes and other congregate-care facilities, hospitals, physicians’ offices and dental clinics. The test is also being distributed across several U.S. states via a program led by the U.S. Department of Defense and the U.S. Department of Health and Human Services, which awarded the San Diego, Calif.-based startup $481 million in October to increase domestic production of point-of-care testing for COVID-19.
The company has financial support from Johnson & Johnson and raised $100 million in a Series C round in June.
This article has been updated with comments from Cue Health.