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). 

ASSURE-19 Featured on Hawaii News Now, Honolulu Star Advertiser, and Pacific Business News

Oceanit is focusing on quickly bringing ASSURE-19 to market, organizing manufacturing so that we can provide schools, emergency responders, and airports with a simple saliva test to make high-risk situations safer. This phase of funding and work will help with regulatory compliance and approval, as well as support for accelerating a ‘go to market’ timeline and scale manufacturing.

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.