NEW YORK – Lucira Health announced on Monday that its Lucira Check It test kit for SARS-CoV-2 received Emergency Use Authorization from the US Food and Drug Administration for over-the-counter use at home.
Lucira also announced preliminary Q1 2021 financial results, with net revenue for the quarter expected to be between $4.0 million and $4.5 million. Average Wall Street estimates for the quarter were $11.7 million. Full results will be reported May 13.
“The first quarter of 2021 was very fluid for Lucira, as the rapid rollout of multiple COVID-19 vaccines, coupled with a temporary inventory build of COVID-19 testing kits and an overall slowdown in testing in the United States, hampered our growth in the point of care,” Lucira CEO Erik Engelson said in a statement.
The company went public in February in a $153 million initial public offering.
The loop-mediated isothermal amplification test received a separate EUA from the FDA in November for prescription use under the name Lucira COVID-19 All-In-One Test Kit.
The Check It test kit can detect a positive result in 11 minutes or confirm a negative result in 30 minutes and is available for people with or without symptoms for $55, the company said in a statement. It doesn't require telehealth or supervised assistance by a healthcare professional.
In the firm's clinical trials, Lucira's test was compared to Hologic's Panther Fusion test and had 97 percent positive result agreement and 98 percent negative result agreement. All users were able to successfully perform the test in about two minutes, the company added.
Lucira also partnered with Converge Technology Solutions to develop a text message-based way to receive verified results on smartphones without using an app. The user can text a code and scan their test result to receive a result verification, or Luci Pass, while results are also transmitted to public health authorities, Lucira said.