Hawaii-made rapid COVID test gets emergency FDA approval

The Assure-rapid test uses a shallow nasal swab to collect a sample, and can offer results within 20-minutes.
Published: Mar. 2, 2022 at 2:37 PM HST|Updated: Mar. 2, 2022 at 5:44 PM HST
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HONOLULU (HawaiiNewsNow) - COVID cases are declining, but experts say the virus will still be around for a while and stress the need for rapid testing.

And when it comes to tests, there’s a new option on the market ― made right here in Hawaii.

Downtown-based company Oceanit recently unveiled its ASSURE-100 rapid antigen test, which uses a shallow nasal swab to collect a sample and can offer results within 20 minutes.

The Food and Drug Administration granted the test emergency use authorization earlier this week after two years of strict regulatory hurdles.

“If any one thing doesn’t work, you start over,” said Oceanit CEO and founder Patrick Sullivan.

“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.”

With mass production underway in Korea, Oceanit has garnered a stockpile of 100,000 tests and plans to scale up to several million a month.

The ASSURE-100 option is not yet available over-the-counter, but will be distributed to healthcare facilities, schools, and private companies.

Engineers say it is able to detect past and future strains of COVID.

“Considering what’s happened over the past two years, it seems like it comes in waves, " said Oceanit senior engineer Tarah Suiter. “So we think that this test will be able to help with that next surge and the ones after that.”

The test is believed to be the first of its kind from Hawaii to land FDA approval and Sullivan hopes this type of innovation will attract more tech investment in the islands.

“The issues that kept us from doing this years ago don’t apply,” Sullivan explained.

“Geography is not the issue and so, what we’re hoping to do is get the rest of the state in particular to understand we can build a diverse economy. We have good people here.”

Oceanit is working with the FDA toward full approval, which would help make it available over-the-counter.

Sullivan says the company is also exploring anti-viral drugs and therapeutics for disease management.

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