Therma Bright Inc. provided an update for the Company's AcuVidTM COVID-19 Rapid Antigen Saliva Test and its U.S. Food and Drug Administration's Emergency Use Authorization application process. The Company's 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 EUA application template requirements. Both the follow-up answers and reformatted data have been submitted, and Therma Bright now patiently awaits a successful FDA response for Emergency Use Authorization (EUA).

On March 29, 2022, after a month of preparation of its AcuVidTM documents and test data, the Company submitted its FDA EUA application for Point of Care Use. The application submission included a great deal of detail on the AcuVidTM COVID-19 Rapid Antigen Saliva Test, including: over 490 combined test results from the U.S. 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. As announced on February 15, 2022, the final U.S. clinical performance study data submitted exceeded the FDA EUA minimum requirements.

However, over the last few months, as the Company worked with FDA officials, irrelevant U.S. Clinical test data was removed, which was submitted in the March 29 EUA application. Upon re-calculating the clinical study results, the Therma Bright team discovered that the U.S. clinical performance study performed better than originally reported. The adjusted U.S. clinical performance study results demonstrated a stronger Positive Percent Agreement (PPA), while Negative Percent Agreement (NPA) remained relatively the same, as originally reported.

This update has now been updated in the Company's EUA application.