Lucira Health announced today that it received FDA emergency use authorization (EUA) for over-the-counter sales of its COVID-19 test kit.
Emeryville, Calif.-based Lucira’s PCR molecular test kit, the Lucira Check It kit, is designed to deliver results in 30 minutes or less at home. The authorization covers those with symptoms and those without, and the test kit can be ordered for $55, according to a news release.
The company’s COVID-19 testing kit was the first to receive EUA for at-home use back in November, although that authorization was for prescription use only. The latest authorization drastically expands the availability of the test. It follows the FDA’s recent authorizations of the BinaxNow Ag card from Abbott (which includes point-of-care screening) and the Quidel Quick-View at-home test for OTC use.
Each Lucira test kit can detect a positive result in as few as 11 minutes or confirm a negative result within 30 minutes, the company said. The company also partnered with Converge Technology solutions to develop a secure, text-based way to receive a free LUCI Pass to their smartphone.
LUCI Pass supports Lucira’s OTC test kit by allowing a user to text a short code to gain access before going through a sequence of steps, including scanning test results and verifying, before results are transmitted to the required public health authorities.
“We worked with more than 1,000 people before starting our FDA clinical and usability studies. Our goal was to produce an easy-to-use test that provides PCR quality accuracy in a portable, intuitive, anytime, anywhere format,” Lucira CEO Erik Engelson said in the release. “People are looking for ways to feel more certain in these uncertain times, and our Lucira CHECK IT test provides that.”