$TBRIF Therma Bright Provides Update on FDA EUA Ap
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Posted On: 06/02/2022 7:53:05 AM
$TBRIF Therma Bright Provides Update on FDA EUA Application Process For AcuVid(TM) COVID-19 Rapid Antigen Saliva Test
https://www.newsfilecorp.com/release/126235
Toronto, Ontario--(Newsfile Corp. - June 2, 2022) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"
, developer of the smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive medical device technologies, is pleased to provide an update for the Company's AcuVid™ 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 AcuVid™ 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 AcuVid™ 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 29th 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.
"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," shared Rob Fia, CEO of Therma Bright. "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. 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. We're excited for the back half of 2022. Therma Bright is preparing for any resurgence of COVID-19 this fall1, as announced in the press."
Therma Bright is not making any express or implied claims that its test product has the ability to eliminate or cure COVID-19 or the SARS-CoV-2 virus.
https://www.newsfilecorp.com/release/126235
Toronto, Ontario--(Newsfile Corp. - June 2, 2022) - Therma Bright Inc. (TSXV: THRM) ("Therma" or the "Company"
, developer of the smart-enabled AcuVid™ COVID-19 Rapid Antigen Saliva Test and other progressive medical device technologies, is pleased to provide an update for the Company's AcuVid™ 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 AcuVid™ 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 AcuVid™ 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 29th 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.
"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," shared Rob Fia, CEO of Therma Bright. "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. 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. We're excited for the back half of 2022. Therma Bright is preparing for any resurgence of COVID-19 this fall1, as announced in the press."
Therma Bright is not making any express or implied claims that its test product has the ability to eliminate or cure COVID-19 or the SARS-CoV-2 virus.
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