JAMA Forum | FDA’s Policy Changes for COVID-19 At-Home Diagnostics—Implications for Addressing Other Infectious Diseases and Future Pandemics

In an article from December 23rd, 2021, Scott Gottlieb, MD from the American Enterprise Institute in Washington, DC discusses how the most enduring technological innovation of the pandemic so far may be the advent of accurate diagnostic tests

COVID-19 Cases Still Growing, Links to Academic Papers

On October 24th, the United States tracked 78,702 new infections of Covid-19, a +32% 14-day change. The same day, 871 new COVID-related deaths were counted, this represents a +15% 14-day change.  Click to find links to important academic papers from experts at Harvard, the University of Colorado at Boulder, Yale University, and more.

Cory Lum/Civil Beat

IN THE NEWS | The Call for Rapid, Point-of-Teed Testing Gets Louder

In Civil Beat this week, reporter Stewart Yerton explored how the calls for fast, frequent and cheap Covid-19 tests are growing stronger by the day. Experts agree that rapid tests can be the critical piece of the puzzle to solve the spread of Covid-19. By detecting infectiousness rather than just presence of the SARS-CoV-2 virus, we can effectively quarantine those who would readily spread the disease – regardless of if that person exhibits or experiences symptoms or not.

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. 

Honolulu Civil Beat – Widespread, Frequent COVID-19 Testing ‘Can Wipe This Off The Planet’

Senior business writer, Stewart Yerton mentioned Oceanit’s ASSURE-19 tests in his Civil Beat article as a possible solution to the expensive, delayed, and low-availability PCR testing in the State of Hawaii. Click to read more.