PRESS RELEASE | Free ASSURE-100 Rapid Tests for Kūpuna and At-Risk Hawai’i Residents as Federal Support Ends
On May 11 the US government will end the COVID-19 Public Health Emergency covering free Covid-19 tests. In response, Oceanit plans to give free ASSURE-100 rapid tests to Hawaii Kūpuna and residents who are at high risk for adverse effects from Covid-19.
IN THE NEWS | FDA Roundup: December 23, 2022
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.
PRESS RELEASE | Oceanit’s ASSURE-100 Rapid COVID-19 Home Test Receives FDA Over-The-Counter Authorization
On December 22, 2022, Oceanit’s ASSURE-100 received FDA Over-The-Counter authorization. The ASSURE-100 Rapid COVID-19 Home Test authorization, an over-the-counter home test, comes ten months after initial point-of-care EUA was granted on February 28, 2022.
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.
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
NYTimes Opinion | Rapid Tests Are the Answer to Living With Covid-19
On Friday, October 1st, Michael J. Mina, professor of epidemiology and immunology & infectious diseases at the Harvard T.H. Chan School of Public Health, and Steven Phillips, vice president of science and strategy at the Covid Collaborative, contributed a guest essay to the New York Times titled, ‘Rapid Tests Are the Answer to Living With Covid-19’.
Testing Surveillance Protocols for Schools
As schools across the country reconvene, administrators are grappling with holding classes in the face of the Delta variant of COVID-19. Coronavirus infections are expected to trend upward, but the New York Times writes that Surveillance may hold the key to keeping the numbers manageable.
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.
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.
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.