Honolulu, HI, March 18, 2024 — Oceanit announced today that its Hawai’i-developed ASSURE-100 Rapid COVID-19 Home Test is now available to families nationwide on Amazon.com, in addition to ASSURE-Test.com.
“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. “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.”
ASSURE-100 is a shallow, nasal swab test that delivers accurate results in just 20 minutes. The test detects all variants of COVID-19 and is read visually on a simple LFA (lateral flow assay) test cassette. ASSURE-100 tests are available on Amazon in packs of six or eight tests, perfect for groups or ‘ohana (families), and ship anywhere in the United States. While the test has been available to organizations and healthcare groups for some time, Amazon’s distribution reach will now make ASSURE-100 accessible to individual consumers, families, and communities. This move ensures that the Hawai’i-based company’s test is readily available to small businesses and consumers across the US.
ASSURE-100 is Oceanit’s first medical product to be commercialized that leverages Oceanit’s proprietary genomic AI model, according to Matthew Sullivan, Oceanit’s Director of Product. “Oceanit takes pride in being a ‘mind to market’ company, and the underlying genomic AI that was critical in the development of ASSURE-100 is now being used to develop diagnostics and therapies for other viruses. Our team is working with Hawai’i and national healthcare partners to expand on ASSURE.” said Sullivan.
The US Food & Drug Administration authorized the ASSURE-100 Rapid COVID-19 home test under an Emergency Use Authorization granted in December 2022. Oceanit is one of just 33 companies worldwide to receive FDA authorization during the COVID-19 pandemic and the only one from Hawai’i.
Founded in 1985 in Honolulu, Hawaii, Oceanit is a disruptive technology company that has earned a world-class reputation for breakthrough science and disruptive innovation built upon values of curiosity, community, and ‘ohana. We are a skilled group of scientists, engineers, and innovators who tackle the world’s most difficult problems.
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Disclaimer: This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA; this product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
