Therma Bright Inc (TSX-V:THRM, OTC:TBRIF) said it has submitted follow-up answers and reformatted data to the US Food and Drug Administration (FDA) for the company's Emergency Use Authorization (EUA) application for its AcuVid COVID-19 Rapid Antigen Saliva Test.
The Toronto-based company said its executive and product development teams have been working with FDA officials to clarify answers to some of the EUA application questions, as well as provided some reformatting of data to better meet the application template requirements.
"Our AcuVid COVID-19 Rapid Antigen Saliva Test performance during the height of Delta and Omicron clearly demonstrates its ability to detect this horrible COVID-19 virus quickly and effectively," Rob Fia, CEO of Therma Bright, said in a statement.
READ: Therma Bright to seek approval for its AcuVid COVID-19 rapid antigen saliva test from Health Canada
“Based on all the test data provided and now reformatted, along with what we hope will be our final responses to several clarify questions by FDA officials, we anticipate a successful conclusion to our Emergency Use Authorization application,” he added.
On March 29, 2022, Therma Bright submitted more than 490 combined test results from the US and Brazilian clinical performance studies, numerous mouth- and nasal-borne viruses and bacteria cross-reactivity tests and World Health Organization's (WHO) Variants of Concern testing to the FDA for its EUA application.
Since then, the company has worked with FDA officials to remove irrelevant US clinical test data as well as adjusted the US clinical performance study results, which demonstrated a stronger Positive Percent Agreement than originally calculated.
“As reference in our recent Health Canada announcement, we plan to use the data and FDA EUA application answers to apply and secure other regulatory approvals around the world,” Fia said. “We're excited for the back half of 2022. Therma Bright is preparing for any resurgence of COVID-19 this fall, as announced in the press."
Therma Bright is a progressive medical diagnostic and device technology company focused on providing consumers and medical professionals with quality, innovative solutions that address some of today's most important medical and healthcare challenges.
The company's initial breakthrough proprietary technology delivers effective, non-invasive, and pain-free skincare.
Contact the author at jon.hopkins@proactiveinvestors.com