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
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.
IN THE NEWS | Testing Still Critical As Travel Opens Up in Hawaii
“We know at least 40% to 50% of individuals are asymptomatic positive, so how are those individuals going to know whether they have the disease or not?” Dr. Scott Miscovich of Hawaii’s Premier Medical Group said. “That’s why you still need to have a large amount of surveillance testing available, while you’re pushing your vaccine rates up at the same time.”
IN THE NEWS | Oceanit’s ASSURE-100 in Honolulu Civil Beat
Oceanit recently spoke with journalist, Eleni Avendaño, about the ongoing trials and development of ASSURE rapid tests. Oceanit’s ASSURE is currently in clinical trials in multiple locations as the rapid tests advance towards submission to the U.S. FDA for Emergency Use Authorization (EUA).
Need For and Use of Rapid COVID-19 Testing In Hawaii Grows
COVID-19 tests are likely to remain part of our new normal, even as the overall pandemic situation stabilizes in Hawaii, says Civil Beat’s Eleni Avendaño in a new article published on June 3rd.
Despite Vaccines, the Need for Rapid COVID-19 Tests Remains
The need for rapid COVID-19 tests will certainly continue throughout 2021, despite the great progress made on vaccines. Shots will reach everyone who wants them, sooner or later, but perhaps not as quickly as we may like. Rapid tests could be made available right now, without a prescription, so we don’t have to wait months for the vaccine to arrive.
IN THE NEWS | Oceanit Progresses Towards FDA EUA Submission
Oceanit has been hard at work to develop and perfect the ASSURE-19 rapid test for submission to the U.S. FDA for emergency use authorization. Hawaii News Now reconnected with Dr. Patrick Sullivan last week to speak about the huge effort being made and the challenges being overcome as ASSURE-19 moves ever-closer to authorization.
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.