More than two years after beginning work on a rapid COVID-19 test, Hawaii’s Oceanit Laboratories has been granted approval from the U.S. Food and Drug Administration to sell its home nasal swab test and hopes to have it in local stores within the next couple of months, according to the company’s founder and CEO, Patrick Sullivan. In February the FDA had approved the test for use in health care settings only.
While life has now largely returned to normal, Sullivan said the FDA’s emergency use authorization is still a big deal for the local biotech company and that the experience the company has gained could help it develop similar products in the future.
In addition to local and national markets, Sullivan said the company is looking at opportunities to sell its ASSURE-100 Rapid COVID-19 Home Test in other countries where the FDA stamp of approval is considered a good vouch for its quality.
Oceanit began work on the test early during the pandemic in 2020 when companies were racing to develop home tests that could help control the spread of the virus and help ease lockdowns. At that time, Hawaii’s economy was in a free fall with the tourist market essentially flatlined and businesses shuttered. Oceanit had hoped that its rapid home tests could be used as an alternative to Hawaii’s 14-day quarantine for visitors, Sullivan told the Honolulu Star-Advertiser in August 2020, as well as help businesses and schools reopen.
But getting FDA approval was a slow and frustrating process. The FDA was overwhelmed with applications, and by the summer had set a high bar for companies to reach as far as test sensitivity. The first home COVID-19 test wasn’t approved until December 2020, and it took months before tests were widely available. Whenever there was a surge in cases, including in Hawaii, over-the-counter tests sold out quickly.
Sullivan said it was difficult having a simple, easy test that could help, but not be able to deploy it. He said the current version of the test sat before the FDA for 200 days.
“It was very frustrating to kind of sit on our hands while it was needed,” said Sullivan. “So we were trying to push the FDA but not burn down the relationship. So that was a delicate balance. I was sympathetic to what they were going through, and I was trying to let them know what we were going through.”
Oceanit initially set out to develop a test using saliva, but Sullivan said the act of spitting proved surprisingly challenging for some people.
“We had the saliva test working, but we had a bunch of folks over from the Legislature to the lab and I was watching them trying to spit on command, and I realized it’s not so easy for everybody,” he said.
Oceanit says that its test is now labeled by the FDA for serial, asymptomatic testing, so people can monitor their COVID-19 status regardless of whether they are experiencing symptoms. Test results are ready in 20 minutes.
Oceanit’s home test is among about a dozen approved by the FDA during 2022.
Correction: This story has been amended to clarify that Oceanit’s COVID-19 test was granted an emergency use authorization by the FDA, approving it for sale as an at-home test. EUAs can be invoked by the FDA during a public health emergency and differ from the typical FDA approval process.
