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FDA Grants Emergency Use Authorization to Oceanit's Point-of-Care COVID-19 Immunoassay

NEW YORK — The US Food and Drug Administration this week granted Emergency Use Authorization to Oceanit's Assure-100 Rapid COVID-19 Test. 

The lateral flow immunoassay is designed for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen from direct anterior nasal swab samples from individuals who are suspected of having COVID-19 by their healthcare provider within the first eight days of symptom onset. 

It is authorized for use by labs CLIA-certified to perform moderate-, high-, or waived-complexity tests, according to the FDA. It is also authorized for use at the point of care in settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. 

"Pre-pandemic, we set out to develop a new approach to managing chronic disease, like cancer, using a human-style artificial intelligence," Patrick Sullivan, CEO of Honolulu-based Oceanit, said in a statement. "When the pandemic started, we quickly pivoted our work and used this tool to design a molecule to bind with a protein inside the SARS-CoV-2 virus," resulting in the Assure-100 test.