IN THE NEWS | Oceanit Joins HPR to Talk ASSURE-100 Over-The-Counter EUA

Dr. Patrick Sullivan and one of the ASSURE-100 team’s lead scientists, Dr. Tarah Suiter joined Hawaii Public Radio’s Casey Harlow to talk about the recent ASSURE-100 Rapid COVID-19 at-home test authorization.

IN THE NEWS | Dr. Patrick Sullivan talks ASSURE-100 with KHON2 Hawaii News

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 | 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.

Oceanit ASSURE-100 Dexter Poon

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