Oceanit, a mind to market company, announced that the US FDA has granted Emergency Use Authorization (EUA) for over-the-counter (OTC) use for ASSURE-100 Rapid Covid-19 Home Test.
ASSURE-100 was previously granted FDA EUA for point-of-care use on February 28, 2022. Oceanit’s at-home test EUA application followed from an entirely new and separate clinical study that was completed and submitted for review to the FDA on May 24, 2022.
“Once the FDA reviewer was 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.
Rapid antigen tests are less expensive and faster than traditional polymerase chain reaction (PCR) tests, offering people an easy and low-cost way to protect family members, classmates, and co-workers during, especially important for the holidays. At-home rapid testing makes it possible for individuals to know their infection status quickly and monitor health over time. A positive result enables the infected person to inform personal decisions, such as isolating or seeking medical treatment, as necessary.
The FDA OTC authorization is a huge milestone for Oceanit, a Hawaii-based technology company of just 200 people.
“I’m very proud of the Oceanit team for creating an affordable rapid test with market-leading accuracy,” said Dr. Sullivan. “Despite being a small team, we did the science, created a user-friendly design, and executed national clinical studies. We set out to develop the simplest, most intuitive, and affordable instrument-free rapid antigen test in the world – and accomplished just that.”
“ASSURE-100 can detect a Covid-19 infection earlier in a person’s infection cycle compared with most other rapid tests on the market, enabling informed decisions – and preventing spread,” Sullivan continued. “Together with vaccines, the ASSURE-100 Rapid Covid-19 Home Test will help our communities stay safe as we go back to our normal routines at work, school, and spending time with family and friends.”
During the development of the ASSURE-100 Rapid Covid-19 Test, Oceanit received support from The Queens Medical Center in Hawai’i, The US Navy Office of Naval Research (ONR), the Defense Advanced Research Project Agency (DARPA), and the Defense Logistics Agency (DLA), as well as the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics’ (RADx) Program, the University of Hawaii School of Tropical Medicine, and Adventists Health Castle Medical Center, among others. Oceanit is grateful for the local community, and global support, of small business innovation in Hawai’.
The ASSURE-100 Rapid Covid-19 Home Test is now labelled by the FDA for serial asymptomatic testing, meaning that people can test themselves regularly to monitor their infection status even without symptoms. ASSURE-100 kits contain only three simple components – a swab, vial, and test cassette – making them easy to use and affordable. The shallow nasal antigen test delivers a result in 20 minutes. Oceanit’s clinical trials for ASSURE-100 over-the-counter use demonstrated an excellent lower limit of detection, sensitivity of 84.7% (positive percent agreement) and specificity of 100% (negative percent agreement) in patients suspected of Covid-19 infection.