ASSURE-100: the only rapid COVID-19 home test from Hawaii
Developed in Hawaii by Oceanit, the ASSURE-100 rapid Covid-19 home test has changed the way individuals can test for the virus in the comfort of their own homes. The test provides accurate, reliable results in under 20 minutes, using a shallow nasal swab for enhanced comfort, making COVID-19 testing fast, easy, and accessible, empowering individuals to monitor their health effectively from home. Oceanit is a Hawaii-based innovation and technology small business, with a team of just 200 people. Fully created in Hawaii, ASSURE-100 was granted two FDA authorizations in 2022, allowing POC and OTC distribution. These approvals allow the test to be used globally by healthcare professionals and at home without requiring a prescription, expanding access to critical diagnostic tools.
ASSURE-100 is a leading rapid test, outperforming competitors in terms of sensitivity and accuracy in detecting infectious levels of SARS-CoV-2.
ASSURE-100 demonstrates better sensitivity at high Ct values (low viral loads) compared with other rapid antigen tests. Data reviewed by US FDA as a part of the ASSURE-100 EUA authorization was plotted with data from a peer-reviewed study (Phase 3b) conducted by the UK COVID-19 Lateral Flow Oversight Team. ASSURE-100 tests were run by healthcare providers while most tests in the study were run by laboratory scientists. It is generally accepted that test performance improves when run by laboratory scientists.
But what challenges did Oceanit face in developing this groundbreaking technology in Hawaii, and how can the state expand its tech sector using this as inspiration?
The Challenge of Developing Technology in Hawaii
Hawaii is known for its stunning landscapes and vibrant culture, but when it comes to technology development, the state faces unique challenges. Limited resources, a smaller talent pool, and the high cost of living can make it difficult for tech companies to thrive in the islands. And yet, Oceanit, founded in 1985 in Honolulu, has built a world-class reputation for groundbreaking science and disruptive innovation. Guided by core values of curiosity, community, and ohana (family), Oceanit’s team of scientists, engineers, and innovators addresses some of the world’s most complex challenges, including advancing solutions for the ongoing COVID-19 pandemic.
Heading into Oceanit’s 40th year of operation, ASSURE-100 is a shining example that disruptive innovation can come from anywhere and that geography is no longer the barrier that it once was.
The Inspiration Behind ASSURE-100
Despite the challenges of distance, Oceanit, a Hawai’i-based research and development company, rose to the occasion and developed the ASSURE-100 rapid Covid-19 home test alongside several supporting partners in the islands. This FDA-authorized test provides results in just minutes, allowing individuals to quickly and easily determine their Covid-19 status.
“Our mission at Oceanit is to bring innovation from Hawaii to the rest of the world. We are just 1 of 33 companies around the world to received FDA authorization during the COVID pandemic. I’m very proud that the Oceanit team was able to do our part to help our nation during this unique time,” said Dr. Patrick K. Sullivan, Oceanit’s founder and CEO.
Expanding Hawaii’s Tech Sector
The success of the ASSURE-100 test could serve as a beacon of hope for Hawaii’s tech sector. By showcasing the innovative capabilities of local companies like Oceanit, Hawaii can attract more talent and investment to the state, fostering a thriving tech ecosystem.
With the right support and resources, Hawaii has the potential to become a hub for technology innovation. The development of the ASSURE-100 test demonstrates that groundbreaking technology can indeed emerge from the islands, putting Hawaii on the map as a center for cutting-edge research and development.
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