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The FDA announced Friday that it issued an emergency-use authorisation (EUA) for Cue Health's COVID-19 test for home and over-the-counter (OTC) use, making it the first molecular diagnostic test available in the US without a prescription. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, stated that the agency "continues to prioritise the availability of more at-home testing options in response to the pandemic."
Specifically, the molecular nucleic acid amplification test is authorised for adults, and children aged two years and older with adult assistance, regardless of whether they have symptoms or other epidemiological reasons to suspect COVID-19. It includes the COVID-19 test cartridge and sample wand nasal swab, both of which are single-use, a cartridge reader and a mobile app. The company says the test provides a fast and automated process from sample collection to results in about 20 minutes using a lower nasal swab.
According to the FDA, the test correctly identified 96% of positive samples from individuals known to have symptoms and 100% of positive samples from those without symptoms. Cue Health expects to produce more than 100,000 tests per day by this summer.
The Cue COVID-19 test was granted is gained an EUA last June for use in clinical and point-of-care settings. It is also being distributed via a programme led by the US Department of Defense and the US Department of Health and Human Services across several states.
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