IN THE NEWS | FDA Roundup: December 23, 2022

On December 23, the U.S. Food and Drug Administration provided an “at-a-glance summary” of news from around the agency, which included the over-the-counter EUA for ASSURE-100 Rapid COVID-19 At-Home Tests. The article included the FDA-issued emergency use authorizations (EUAs) for two recent OTC at-home COVID-19 Tests, for ages 14 years or older with a self-collected nasal swab sample or age 2 years or older when an adult collects the nasal swab sample.

Oceanit’s EUA application for at-home tests followed a full clinical study that was completed in May, 2022.  Oceanit then submitted the ASSURE-100 over-the-counter application to the FDA for review on May 24, 2022.

“Once the FDA reviewers were able to get to our application, it went quickly, but the process required timely Oceanit responses, typically within 48 hours of a question or request for clarification. This requirement had the Oceanit team flying across the country to collect data or use special equipment,” said Dr. Patrick Sullivan, Oceanit’s CEO, “However, once we developed a rhythm with the FDA team, we were impressed that they also worked evenings and weekends to get this done.”

Oceanit’s ASSURE-100 was one of thirteen COVID-19 OTC tests authorized by FDA this year. You can read the full FDA Roundup here:  https://www.fda.gov/news-events/press-announcements/fda-roundup-december-23-2022

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