FDA Authorizes First OTC, At-Home COVID-19 Test

FDA on Tuesday (Dec. 15) authorized for emergency use the first fully at-home over-the-counter COVID-19 diagnostic test. The test, which was developed by Ellume and can be used to diagnose people 2 years of age and older, connects to an app that delivers results to patients’ phones and reports results to local public health officials. Ellume expects more than 3 million tests to be manufactured by the end of January 2021, FDA says in its Tuesday press release. The agency...