On December 23, the U.S. Food and Drug Administration provided an “at-a-glance summary” of news from around the agency, which included the over-the-counter EUA for ASSURE-100 Rapid COVID-19 At-Home Tests.
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ASSURE In the News
PRESS RELEASE | Oceanit Receives FDA Emergency Use Authorization for ASSURE-100 Rapid COVID-19 Tests
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.
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.
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.
The Aloha Protocol For a Safer Reopening with ASSURE-19
As Oceanit moves ahead with in-vitro and in-vivo testing for the ASSURE-19 rapid point-of-need test kits, Hawaii is seeing high, sustained counts for new covid-19 cases each day. Check out the latest articles and coverage of ASSURE-19 from the Washington Post, Hawaii Public Radio, and Honolulu Star Advertiser.
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.
KITV Island News – Patrick K. Sullivan Discusses ASSURE-19
On Monday, August 3rd, Dr. Sullivan joined KITV 4’s Evening Island News program for a live interview about ASSURE-19’s progress. Hosts Mika Miyashima and Brenton Awa on heard about our progress, how the test works, scale up plans, and how ASSURE-19 has the potential to reopen Hawaii. Click to watch.
Honolulu Star Advertiser: Hawaii Coronavirus Saliva Test Could Help Turn Pandemic’s Tide
CEO Dr. Patrick Sullivan spoke to The Star Advertiser’s Mindy Pennybacker about how the ASSURE-19 rapid “spit test” can help to protect lives and responsibly help to restore the economy and the unique ‘capture and detector molecule’ approach to COVID-19 respiratory disease detection. Click to read more.