PRESS RELEASE | Oceanit Receives FDA Emergency Use Authorization for ASSURE-100 Rapid COVID-19 Tests
FOR IMMEDIATE RELEASE
- ASSURE-100 Rapid COVID-19 Tests quickly and reliably detect all variants of SARS-CoV-2, including the delta and omicron.
- Simple, easy to use and affordable ASSURE-100 tests require no special equipment.
- Expectations include enabling diverse communities, from schools to businesses and government, to reduce risk and get back to “normal” – reducing the risk of COVID-19 infection.
Honolulu, HI, February 28, 2022 – Oceanit, a Mind to Market company, announced today that the U.S. Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) for Oceanit’s ASSURE-100 rapid antigen test for detection of COVID-19. ASSURE-100 uses a shallow nasal swab to collect samples from individuals. With only three components – swab, vial and cassette – it’s relatively easy and simple to use, requiring no lab or supplementary instrumentation.
A positive test result using ASSURE-100 enables the infected person quickly to inform personal decisions: to immediately isolate or seek medical treatment, as needed. As we learn to live with the COVID-19 virus and its variants, rapid tests will become the indispensable tool of the “new normal,” reducing risk at in-person social events for work, family, entertainment, etc. In clinical study data the ASSURE-100 test demonstrated an excellent lower limit of detection, sensitivity of 89% (positive percent agreement) and specificity of 100% (negative percent agreement) in patients suspected of COVID-19 infection.
“It’s been a long, winding, journey to get to this point,” said Dr. Patrick Sullivan, Oceanit’s CEO. “However, we have an amazing, talented and hard-working team that never gave up. Pre-pandemic, we set out to develop a new approach to managing chronic disease, like cancer, using a human-style artificial intelligence, which we referred to as ‘anthronoetic artificial intelligence.’ To build an AI that thinks like a human, as opposed to traditional machine learning, which is brittle and fails outside a very narrow application, we used linguistics as a surrogate to human intelligence. This led Oceanit’s team to develop a tool, referred to as the ‘grammar of RNA’ to consider a big question – biological causality, e.g., answering the question: why does subject X get a disease like cancer, but subject Y is spared, except using math,” said Dr. Sullivan.
“The goal was to move away from medical correlation approaches used today and focus more on causality – sort of like physical sciences,” Sullivan continued. “We then started looking at genetics more like a language, e.g., reading genetics like a book, versus just reciting letters/ symbols on a page. We have more work to do, but when the pandemic started, we quickly pivoted our work and used this tool to design a molecule to bind with a protein inside the SARS-CoV-2 virus. That was a huge accomplishment, but bringing the technology to market proved equally challenging — we needed to address scalability – manufacturing, clinical, regulatory, etc. Today we have a robust rapid test that is simple and easy to use and can be produced in significant volume.”
Oceanit is grateful for the community encouragement and the support we received from the Office of Naval Research (ONR), the Defense Advanced Research Project Agency (DARPA), the Defense Logistics Agency (DLA) as well as the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics’ (RADx) Independent Test Assessment Program (ITAP), the University of Hawaii School of Tropical Medicine, The Queens Medical Center, and Adventist Health Castle Medical Center, among others.
Together with vaccinations, ASSURE-100 rapid COVID-19 tests can help the world get back to “normal” while staying safe. Learn more at https://assure-test.com
Founded in 1985, Oceanit is a “Mind to Market” company that creates disruptive technology from fundamental science. Utilizing the unique discipline of Intellectual Anarchy, Oceanit reimagines innovation to break the bonds of normal and solve the impossible — delivering technologies to the market that impact humans and society. Oceanit’s diverse teams work across aerospace, healthcare, energy, and industrial/ consumer technologies, as well as on environmental and climate matters. Through engineering and scientific excellence, Oceanit transforms fundamental science into impactful, market-focused technologies used around the world.
Important Information about ASSURE-100 Rapid COVID-19 Tests
ASSURE-100 Rapid COVID-19 Tests have been authorized by the FDA under an emergency use authorization. The test has been authorized only for the detection of SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for emergency use of in vitro diagnostic testing for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1).