PRESS RELEASE | ASSURE-19 Begins Clinical Testing to Acquire FDA Emergency Use Authorization
Oceanit and the Queen’s Medical Center have started patient trials with ASSURE-19 rapid point-of-need Covid-19 tests as of Saturday, August 22. Oceanit is collaborating with Dr. Todd B. Seto, Queen’s Medical Center’s director of academic affairs and research, to obtain critical test data. This is the beginning of the journey to acquire US Food and Drug Administration Emergency Use Authorization (EUA).
The goal is to have ASSURE-19 approved by the FDA to quickly identify individuals who are infected with the Covid-19 virus, particularly those who have been exposed but may be asymptomatic or pre-symptomatic – posing a potentially high infectious threat to others.
According to the U.S. Centers for Disease Control and Prevention, approximately 50% of Covid-19 transmissions occur prior to symptom onset, and 40% of infections remain asymptomatic throughout the duration of the infection. An infected person typically reaches peak contagiousness between days 4-6 after exposure, but asymptomatic and pre-symptomatic testing rarely occurs. Nevertheless, SARS-CoV-2 is spreading at alarming rates as exposed individuals unwittingly infect family, friends, and co-workers.
The key to containing infectiousness is testing with speed, affordability, simplicity, and regularity. Individuals need to be able to test themselves at the point-of-need without requiring any equipment or specialized training.
Once approved, Oceanit will roll out a smartphone app that can document results, which could be shared with employers, airport travel screeners, schools, etc. Oceanit plans to manufacture some tests in Hawaii to support local businesses, schools, and other critical workforces like firefighters, police, and first responders at the level of approximately 25,000 tests per day.
The ‘Aloha Protocol’ for a safe reopening
Oceanit is laying out a protocol that will enable creation of a safe bubble for all of Hawaii while safely restoring the economy and tourism. We call this plan for a persistent testing regimen the Aloha Protocol.
“The concept is for all passengers to be tested when they arrive at our airports. A negative result means you can leave the airport, but you also receive five more ASSURE-19 tests to self-test for repeat testing during the next five days,” says Dr. Patrick Sullivan, Oceanit’s CEO.
“Think of the Aloha Protocol like a prescription: ‘take these tests, once per day, for six days.’ All six ASSURE-19 tests together cost less than a single PCR test, and if you test positive with one, you go into quarantine for 14 days. Various versions of this protocol would apply for schools, airports, businesses, etc.”
With ASSURE-19, the accessibility of self-testing is also expected to modify compliance behavior through increased community participation via the “ritual of testing”, which delivers a result in about 10 minutes. Under the Aloha Protocol, those who take tests and receive a negative result each day will be able to move freely, going to the beach or to school, work, travel, attend events or social gatherings, etc.
With regular, persistent testing, those who may have been exposed to the SARS-CoV-2 virus through close contact, but who are pre-symptomatic or asymptomatic, would be able to test for Covid-19 without waiting for approval on a PCR test. ASSURE-19 could be used to open up sporting events, large gatherings, concerts, and bring back a limited version of ‘normal’ in this chaotic time.
This would alleviate the stress on scarce and expensive lab test supplies through scaled availability and affordability, enabling enough daily testing to re-mobilize the economy while quickly detecting those who may pass the SARS-CoV-2 virus along.
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