Oceanit receives U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the ASSURE-100 rapid antigen test for detection of COVID-19.
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ASSURE In the News
PRESS RELEASE | Oceanit Receives FDA Emergency Use Authorization for ASSURE-100 Rapid COVID-19 Tests
PRESS RELEASE | National Institutes of Health Approves Next Round of ASSURE-19 Funding Under the RADx ‘Next’ Program
Oceanit Laboratories received approval from NIH for next round funding under the RADx initiative, receiving an additional $250,000 for further development of the ASSURE-19 rapid Covid-19 saliva test. With this latest round of funding, Oceanit will have access to additional NIH R&D resources through the RADx network of core partners, which can help to expedite moving ASSURE-19 to market.
PRESS RELEASE | Oceanit Selected As a Semi-Finalist For the XPRIZE Rapid Covid Testing Competition
Oceanit’s ASSURE-19 Covid-19 test was selected as a semifinalist from a pool of nearly 700 teams from around the world competing for the XPRIZE for Rapid Covid Testing. We will now perform blind proficiency testing on inactive virus samples sent to us by the XPRIZE Foundation as the next step towards becoming a finalist for the award.
PRESS RELEASE | ASSURE-19 Begins Clinical Testing to Acquire FDA Emergency Use Authorization
Oceanit and the Queen’s Medical Center have started patient trials with ASSURE-19 rapid point-of-need covid-19 tests as of Saturday, August 22. Oceanit is collaborating with Dr. Todd B. Seto, QMC’s director of academic affairs and research, to obtain critical test data. This is the beginning of the journey to acquire US Food and Drug Administration Emergency Use Authorization (EUA).
Press Release | AUG 20: NIH Funding and Moving to Trials
Oceanit Laboratories’ ASSURE-19 rapid point-of-need COVID-19 test has been selected for continued support by the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADxSM) initiative, to fill the nation’s critical need for rapid, simple, and affordable COVID-19 testing.