Locally developed COVID test gets FDA approval for over-the-counter use
Locally-based engineering firm Oceanit first developed the ASSURE-100 Rapid COVID-19 test at the height of the pandemic.
"We had been working on an artificial intelligence tool to design molecules with a toolset we call the grammar of RNA," said Patrick Sullivan, CEO of Oceanit. "We thought we should do something useful in the pandemic, so we produced a point-of-care rapid test."
At the time, Sullivan told HPR that the FDA wasn't considering over-the-counter products, so the firm had to conduct clinical tests across the country. In February, the FDA approved giving the test an emergency use authorization for use in health care settings.
However, the firm had to undergo a separate study for over-the-counter approval. But the process didn't begin until May 2022, when the FDA required Oceanit to submit several tests before it began its own studies.
"We had to do a bunch of lab studies — looking at how our test behaves with a whole range of viruses and bacteria and other random substances," said Tarah Suiter, senior engineer at Oceanit — specifically working on the regulatory and clinical work for the ASSURE tests.
In addition to clinical studies, Oceanit had to compare the ASSURE test's accuracy, or sensitivity, with a PCR test.
"From our clinical trial for over-the-counter, our sensitivity was 84.7%," Suiter said.
But when tested serially, or multiple tests throughout a period of time, Suiter said the ASSURE test had "really, really high sensitivity — in the 90s."
According to Sullivan, that made the ASSURE test one of the best ones the FDA investigated and approved. Oceanit's test is one of a dozen to receive FDA over-the-counter approval this year.
Sullivan said the firm is working with retailer CVS and others to sell the test. He expects the product to be on store shelves in the next few months.
Editor's note: Oceanit is a corporate underwriter of Hawaiʻi Public Radio.