Therma Bright Inc (TSX-V:THRM, OTC:TBRIF) announced that a clinical performance study of its AcuVid COVID-19 Rapid Antigen Saliva Test has successfully exceeded US Food and Drug Administration's Emergency Use Authorization (EUA) requirements for both Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA).
The company said its management and product development teams are currently compiling the US Clinical Performance Study results with all supplemental studies into one complete FDA EUA application for submission.
“This achievement places Therma Bright in a very unique leadership position as the first company in the COVID-19 diagnostic testing space to successfully complete a 15-minute rapid antigen saliva-based U.S. study,” the company said in a statement.
READ: Therma Bright completes US Clinical Performance Study subject recruitment for its AcuVid COVID-19 Rapid Antigen Saliva Test
Therma Bright said the US clinical study results include a PPA of 80.3% and a NPA of 98.0%.
In total, both the US Clinical Performance Study and Brazilian Clinical Study tested over 490 patients, more than other COVID-19 rapid antigen test manufacturers prior to their FDA EUA for point of care (PoC). The AcuVid saliva test also achieved successful results on several mouth-based bacteria and viruses in additional cross-reactivity study requests from the FDA, which other EUA test manufacturers did not have to conduct.
The AcuVid US Clinical Performance Study was conducted from December 2021 through January 2022 when the Omicron B.1.1.529 variant became the dominant strain across the US. Similarly, when the AcuVid Brazilian Clinical Study was completed in July 2021, the South American country's dominant variants were P.1 and P.2.
Therma Bright noted that these two clinical studies "not only demonstrate, but also validate, the effectiveness" of the 15-minute COVID-19 rapid antigen saliva test's ability to detect the original SARS CoV-2 coronavirus, as well as the growing list of World Health Organization's (WHO) Variants of Concern.
Furthermore, the company has begun work on its FDA EUA efforts for AcuVid at-home use, and continues to work with its valued partners to improve the performance of its rapid antigen saliva test for this self-test submission.
"Since July 2021, our team has worked diligently with FDA officials, doctors and scientists in our pursuit to meet all the EUA requirements,” said Therma Bright CEO Rob Fia. “It's our belief we have achieved all requests and requirements, and have one of the most tested pre-EUA COVID-19 rapid antigen tests for submission. Once our final FDA EUA application for Point-of Care is complete, we will submit and patiently await authorization."
Therma Bright added that it believes the test will play a critical role in detecting and mitigating the spread of this virus and its growing list of variants, including the current Omicron B.1.1.529 variant.
Contact the author: patrick@proactiveinvestors.com
Follow him on Twitter @PatrickMGraham