Oceanit CEO, Dr. Patrick Sullivan joined KHON2’s Gina Mangieri in-studio to discuss ASSURE-100’s at-home authorization and explain how such feats of science are no longer about geography.
In The News
ASSURE In the News
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.
New Study Finds 100% Correlation Between Rapid Antigen Test Results and Culturable Virus Levels
Researchers have been studying the question of whether rapid antigen tests are a good indicator of contagiousness, or infectiousness, when it comes to the SARS-CoV-2 virus.
Hawaii News Now | Hawaii-Made Rapid COVID Test Gets Emergency FDA Approval
Hawaii News Now visited Oceanit office to interview the ASSURE team about the recent US FDA Emergency Use Authorization for the ASSURE-100 Rapid COVID-19 test
KITV4 | Oceanit Gets Emergency Clearance for Rapid COVID-19 Tests
KITV4 Island News visited Oceanit’s offices and labs yesterday to speak with Oceanit CEO, Dr. Patrick Sullivan about the newly authorized ASSURE-100 Rapid COVID-19 Test.
HPR | FDA Approves Emergency Use for First Rapid COVID-19 Test Developed in Hawaiʻi
Oceanit CEO, Dr. Patrick Sullivan joined Hawaii Public Radio host, Catherine Cruz to discuss the ASSURE-100 Rapid COVID-19 Test. Their ten minute discussion covered the research & development that went into ASSURE-100, the FDA EUA process, and what comes next.
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’.