Hogan Lovells advises Lucira Health in obtaining the first FDA Emergency Use Authorization for an at-home COVID-19 testing kit

Lucira’s COVID-19 All-In-One Test Kit allows users aged 14 and older to take a nasal swab and obtain results in 30 minutes or less by placing the sample into the test unit. The test kit has also been approved for use in point-of-care settings, such as doctor’s offices, for use with samples collected by health care providers for children younger than 14 years. Some Emergency Use Authorized kits allow for home collection of samples, but still require users to mail samples to a lab for testing, which can delay results for days or weeks.

Reporting and tracking are critical components to battling the pandemic. While prescribing health care providers are required to report all test results for tracking and monitoring, Lucira Health’s test kit also provides box labeling, quick reference instructions, and health care provider instructions to assist with reporting efforts.

“We were thrilled to work with talented individuals at Lucira and the FDA to help get this EUA issued in order to better fight the COVID-19 pandemic,” said Randy Prebula, head of Hogan Lovells Medical Device & Technology regulatory practice. “This rapid at-home test is a critical step in helping patients across the U.S. track and monitor COVID-19 in their communities and nationwide.”

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, and Melissa Bianchi assisted on other regulatory matters.