Hawaii News Now | Hawaii-Made Rapid COVID Test Gets Emergency FDA Approval
Hawaii News Now visited Oceanit’s Honolulu offices to interview the ASSURE team about the recent US FDA Emergency Use Authorization (EUA) for the ASSURE-100 Rapid COVID-19 test.
HNN Reporter Mark Carpenter spoke with Oceanit CEO, Patrick K. Sullivan and Senior Engineer, Tarah Suiter about the challenges of being a small, Hawaii-based company competing for the FDA’s attention against the much larger mainland healthcare companies. The strict regulatory hurdles put in place, combined with the unforgiving nature of the authorization process, meant that Oceanit needed to be airtight when submitting and defending an EUA application.
“If any one thing doesn’t work, you start over,” said Oceanit CEO and founder Patrick Sullivan of the FDA EUA process. “It just is totally unforgiving and what the FDA told us is that if you can’t respond to any question within 48 hours, you’re out.”
Fortunately, the ASSURE-100 Rapid COVID-19 Test lived up to the strict regulatory expectations of the reviewers and Emergency Use Authorization was granted on February 28th for point of care use. ASSURE-100 is not yet available over-the-counter (OTC), but will be distributed to healthcare facilities, schools, and private companies while Oceanit pursues OTC approval.
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