Therma Bright Seeks Emergency Use Authorization for its AcuVid COVID-19 Test
Toronto, Canada-based Therma Bright said it will seek Emergency Use Authorization from the FDA for its AcuVid COVID-19 rapid antigen saliva test, supported by results from two clinical trials in the U.S. and Brazil.
The U.S. study took place in December and January, when the Omicron variant became the dominant strain across the U.S. The 15-minute point-of-care test correctly identified 80.3 percent of positive samples and 98 percent of negative samples, the company said.
Therma Bright said it is “the first company in the COVID-19 diagnostic testing space to successfully complete a 15-minute rapid antigen saliva-based U.S. study.”
Similar results were reported in the Brazilian study, which was completed last July, when the South America country's dominant SARS-CoV-2 variants were Gamma (P.1) and Zeta (P.2).