FDA has given emergency authorization to Lucira Health's at-home molecular COVID-19 test for over-the-counter use.
Lucira became the first company to receive emergency use authorization for a rapid, at-home COVID-19 test in November. The new EUA extends the nod to support OTC sales, enabling the diagnostics company to start selling the test on its website for $55 per kit.
The OTC authorization adds to the competition in the emerging COVID-19 testing market. In recent months, FDA has cleared antigen and molecular coronavirus tests from companies including Abbott and Cue Health for emergency OTC use.
Lucira, formerly known as DiAssess, worked on at-home infectious disease tests for years before the pandemic, securing government grants and limited venture capital investment to fund the work. The pandemic changed the company's fortunes, leading to a $153 million IPO in February. Lucira now faces the challenge of delivering on the raised expectations.
The California-based medtech took a step toward that goal on Monday when it disclosed an EUA for OTC use of its single-use COVID-19 test. Lucira brought the real-time loop-mediated amplification kit to market by showing 100% of users successfully performed the test in two minutes. The test can deliver a positive result in 11 minutes and a negative result within 30 minutes.
Compared to Hologic Panther Fusion, the positive and negative percent agreements were 92% and 98%, respectively, in a mix of 404 symptomatic and asymptomatic people. Removing infections with very low levels of virus from the analysis increased the percent positive agreement to 97%.
The test is now available for sale online for $55. The price is considerably higher than the figure Lucira discussed in its IPO paperwork earlier this year. At that time, Lucira said "an OTC COVID-19 test kit would need to be at a consumer-appropriate retail price which, based upon our analysis of the consumer healthcare market, is approximately $20 per test kit."
Lucira will now find out if $55 is an attractive price point for consumers. In conjunction with news of the EUA, Lucira said it expects net revenues for the first three months of 2021 of $4 million to $4.5 million. The revenues came from prescription sales prior to the OTC authorization.
Investors responded favorably to the simultaneous announcement of the OTC authorization and the preliminary first quarter revenues, sending shares of Lucira up 27%. However, the first quarter sales figures reflect recent challenges.
"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.