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Hawaii-based technology company Oceanit is entering the new year in the next phase of scaling its ASSURE-100 rapid Covid-19 home test.
The product was recently granted Emergency Use Authorization for over-the-counter use by the U.S. Food and Drug Administration in late December of 2022. The authorization comes 10 months after an initial point-of-care EUA was granted February 28, 2022.
“It did take longer than what we expected, but this is a big milestone for us – we are one of just 13 tests to receive authorization, and the the only small business from Hawaii,” said Matthew Sullivan, director of product, in an interview with Pacific Business News.
Sullivan said Oceanit’s strategy was to start distributing the ASSURE-100 test in hospitals and schools and build from there, both locally and on the Mainland.
On the timing of Assure hitting the market, he said, "We don't see it as being late to a game since we’re not sure how much longer the Covid-19 pandemic will go on for, but we are switching gears from clinical to regulatory sales, and trying to be better prepared.”
Now, he’s in conversations with buyers within the federal and state government, in addition to corporations such as CVS and Amazon. “We’re looking to put our tests online to make it more accessible and convenient,” he said.
“We can supply small volumes today; we’ve been scaling manufacturing [in South Korea] up to 20 million tests a day now,” Sullivan said. “So, the capacity is there, but the problem right now is demand. We’re trying to be market competitive and forecast trends by looking months out.”
Sullivan added, despite its various other science and energy projects underway, Oceanit remains focused on propelling the Assure-100 test forward.
“Our test is quality and performed well in the clinical trials, plus it’s affordable,” Sullivan said.
“At Oceanit, we want to inspire local people, showcasing that it is possible to do things like this from here,” he added. “We’re making good progress and the hope is that we continue to invest in resiliency.”
Learn more at assure-test.com.
