Hogan Lovells advises Lucira Health in securing Emergency Use Authorization for over the counter at-home COVID-19 test

The kit delivers PCR quality molecular accuracy in 30 minutes or less at home, and can now be ordered online on Lucira Health’s website. Molecular tests like Lucira’s are more sensitive and reliable than the more common antigen tests. The test kit, which fits in the palm of your hand, also can send a text message to its users with their test results so they can quickly verify a passing test if needed. These results are also transmitted to the required public health authorities.

Hogan Lovells also advised Lucira to obtaining an EUA for its at-home test kit back in November. That authorization was the first time FDA had authorized any prescription, molecular diagnostic test for COVID-19 that could be self-administered by patients at home or used in a physician’s office. This new EUA for OTC sale greatly expands the availability of this kit.

“It has been a rewarding experience to work with Lucira and my colleagues at Hogan Lovells to advance this this critical COVID-19 test kit through two Emergency Use Authorization processes,” said Randy Prebula, head of Hogan Lovells Medical Device & Technology regulatory practice. “I’d also like to thank the FDA for its cooperative forward-thinking approach that helped move this authorization through the process.

The Hogan Lovells team was led by Medical Device & Technology regulatory partners Randy Prebula and Jonathan Kahan, and also included Senior Director Susan Tiedy-Stevenson, Director of Regulatory Sciences Alex Smith, and senior associate Erkang Ai. Partner Beth Roberts and counsel Brooke Bumpers assisted on health care and reimbursement issues, and partner Allison Pugsley worked on government contract questions. Partners Mike Heyl, Eliza Andonova, Melissa Bianchi, and Scott Loughlin, and counsel Anishiya Abrol, assisted on other regulatory matters.

More information can be found in Lucira’s press release.