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Oceanit readies rapid COVID-19 test developed in Hawaii for FDA approval


                                Oceanit Laboratories’ rapid COVID-19 test resembles a pregnancy test. Above, CEO and founder Patrick Sullivan with the virus test kit in Oceanit’s lab.


    Oceanit Laboratories’ rapid COVID-19 test resembles a pregnancy test. Above, CEO and founder Patrick Sullivan with the virus test kit in Oceanit’s lab.

A COVID-19 saliva test developed in Hawaii and ranging in price from $5 to $20 could be approved by the U.S. Food and Drug Administration within weeks, although it could be months before it’s widely available.

Oceanit Laboratories founder and CEO Pat Sullivan told the Honolulu Star- Advertiser’s Spotlight Hawaii on Friday that the test, which looks similar to a pregnancy test, is in the final stages of validating, with the biotech company aiming to get an application in to the FDA by the end of the month.

The rapid test, which could be used in schools, businesses and other settings and to ensure the safety of visitors coming into the islands, provides results in three to 10 minutes.

“We’re hopefully weeks away from FDA approval. If we get approval at the end of the month, it’ll take us months to kind of get up and running,” Sullivan said. “What we’re trying to do is find some ways to go faster in spurts so that we can start producing for some of the local businesses and the folks who could really use the test.”

Also Friday, state officials reported one new coronavirus death on Oahu and 89 new infections statewide, bringing the totals since the start of the pandemic to 185 fatalities and 13,853 cases. The latest death was an Oahu woman over age 80 with an underlying medical condition.

The state Health Department has yet to verify a number of deaths related to the new coronavirus. As of Friday there were 2,721 active infections statewide and 10,947 patients now considered recovered, or 79% of those infected.

The Oceanit development comes as the tourism industry reopens, with more than 10,000 passengers arriving Thursday, the first day of the state’s pre-travel testing program allowing passengers with negative results from COVID tests done within 72 hours of arrival to bypass Hawaii’s 14-day quarantine.

Sullivan said as more people travel to the islands, there will no doubt be a surge in cases.

“We’re going to have another lockdown; there’s no way around it. The probability of finding or having an incident increasing the numbers, I don’t think it’s a question of if; it’s just a question of when,” he said. “Seventy-two hours before you travel … is a good gesture, but in terms of reducing risk, it’s minor.”

Oceanit’s test, known as ASSURE-19, could help catch anyone who might fall through the cracks, according to Sullivan.

“Unless you can test everybody walking off the airplane and implement this kind of program, it’s very hard to contain the infectiousness in the community. It’s a tough problem because we like to keep the businesses that support the visitor industry alive,” he added.

“The discussion on the neighbor islands about a second test, that’s the right idea. You have to do more than what you’re doing. That’s going to reduce risk, but it ain’t going to get rid of it.”

The only way to “crush” the virus is by having a rapid test like ASSURE-19, which could be repeated daily for at least a week, the time when the virus is likely to fully develop, he said.

“The idea is to live with the virus. You start with schools — kids going into the classroom — and everybody, of course, walking off the airplane,” Sullivan said. “You can do restaurants, businesses and other things so that what you’ve got is everybody in bubbles and they’re not at risk of infecting everybody around them.”

Oceanit’s tests can be manufactured in Hawaii, but it’s a “question of political will,” according to Sullivan.

The company started discussions with state officials months ago about setting up a plant in Hawaii to produce 25,000 tests per day, but the concept has yet to be accepted, said Sullivan, who would need roughly 50 people for manufacturing.

One of the pillars of the state’s COVID-19 recovery is diversifying the local economy so it isn’t so dependent on a fragile tourism industry.

“From my perspective it’s kind of an attitude shift. We need to take an attitude that we’re going to save ourselves as a community. Are we interested in really creating a diverse economy, or do we just want to talk about it?”

Spotlight Hawaii shines a light on issues affecting Hawaii, streaming live on the Star-Advertiser’s Facebook page at 10:30 a.m. Monday, Wednesday and Friday.

Click here to see our full coverage of the coronavirus outbreak. Submit your coronavirus news tip.

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