HONOLULU — A locally developed COVID-19 test kit is now on the market as cases of the contagious disease are on the rise in Hawai‘i.
Honolulu-based Oceanit’s ASSURE-100 Rapid COVID-19 Home Test is being sold on Amazon.com. ASSURE stands for Accelerated Sensor Solution for Urgent Response to Epidemics.
A pack of six tests costs $44.94, and a pack of eight costs $59.92 — or about $7.49 a test.
The test became available on the online marketplace in March after obtaining emergency use authorization by the U.S. Food and Drug Administration in 2023.
Like many other tests on the market, it is a nasal swab test that shows results after 20 minutes.
“Expanding the reach of ASSURE-100 through Amazon is a great way for us to help spread Aloha, not COVID,” said Oceanit CEO Dr. Patrick Sullivan in a statement. “We are delivering our leading test from Hawai‘i to the world — and with seasonal surges, availability to those shopping on Amazon is a great step. We’re very proud that ASSURE-100 is the only FDA-authorized test created in Hawai‘i.”
The FDA approved ASSURE-100 for emergency use in December 2022, allowing it to be sold over the counter to consumers. Previously, it had been approved for use in health care settings only. It had also been available mostly to schools and health care groups.
Oceanit said it is one of just 33 companies worldwide to receive FDA authorization during the COVID-19 pandemic, and the only one from Hawai‘i approved.
Jay Andrews, Oceanit’s director of marketing, said the test was developed in Hawaii in partnership with the University of Hawai‘i John A. Burns Medical School and The Queen’s Health Group. The parties worked together to conduct clinical trials.
“It was a long, difficult journey for us, but a story of a Hawai‘i community success,” he said.
Because it was developed further along the pandemic timeline, trials showed ASSURE-100 tests performed better with more recent omicron variants, he said.
It is also Oceanit’s first medical product to be commercialized using the company’s proprietary genomic artificial intelligence model.
The AI technology was initially being used to read cancer genomes, according to Andrews, but when the pandemic hit, the company pivoted to developing a COVID-19 test kit.
The AI can be used to design the required molecular chemistry for a particular virus, and by providing a “response” to the presence of the virus by matching to that virus’ genomic code. The development of the test kit involved decoding of the COVID-19 virus’ genomic code to custom-build a response molecule for a specific protein antigen from the SARS-CoV-2 virus.
Initially, Oceanit was developing a rapid test detecting COVID-19 via saliva, but the product evolved to a nasal swab test.
Each test kit has two nasal swabs, which are mixed with a buffer solution in a vial, with drops placed on a “lateral flow assay” or cassette. One control line means no COVID-19 was detected. Two lines means COVID-19 was detected.
Although Oceanit’s goal is to eventually have the tests manufactured in Hawai‘i, they are currently manufactured through a partner in South Korea.
On Wednesday, the state Department of Health urged the public to be vigilant amid high levels of COVID-19 in the state.
The statewide average positivity rate has skyrocketed to 15.9 percent, continuing a trend that began in late April as new “FLiRT” variants established a foothold in the state. Hospitalizations of COVID-19 patients are also closing in on an average of 100 a day.
Oceanit’s COVID-19 tests can also be purchased online at assure-test.com.
Founded in 1985, Oceanit describes itself as “a disruptive technology company” focused on breakthrough science to tackle the world’s most difficult problems.
How in the world are people in Hawaii still talking about covid? The biggest scam in history and half of you still blind. Please have some common sense and wake up.
How much of our tax payer monies spent to develop this product at UH labs? Do we have a cut in the profits now???