Therma Bright Inc (OTCMKTS:TBRIF) (TSXV: THRM) is currently best known for its smart AcuVid™ COVID-19 Rapid Antigen Saliva Test but at the same time, it is perhaps necessary to note that the company has also come up with a number of innovative diagnostics as well as medical device technologies.
The company was actually in the news earlier on in the week on March 29 and it could be the right time for investors to take a look at that announcement. The company announced at the time that it had made a submission to the United States Food and Drug Administration for the purposes of getting an Emergency Use Authorization for its AcuVid™ COVID-19 Rapid Antigen Saliva Test for Point of Care product. It was a major new announcement from the company and one that is likely to bring the stock into focus among investors as well.
The Chief Executive Officer of the company Rob Fiastpoke about the development as well. He announced that the data that was added to the application had been sourced from the clinical performance study that had been conducted in the United States and the one that had been conducted in Brazil.
In this regard, it is perhaps also necessary to point out that as far long back as July last year, the development teams and the executives at the company have been working with the officials at FDA. Hence, it is now going to be interesting to see how the whole thing progresses now that the application has finally been submitted.
Key Quote
“I am pleased to announce the submission of our AcuVid™ COVID-19 Rapid Antigen Saliva Test for U.S. Food & Drug Administration’s Emergency Use Authorization,” shared Rob Fia, CEO of Therma Bright. “Our application includes data from our U.S. clinical performance study, Brazilian clinical study, all required cross-reactivity tests, additional FDA requested cross-reactivity tests for mouth-borne viruses and bacteria, and numerous tests around World Health Organization’s (WHO) Variants of Concern (VOCs), such as Delta and Omicron. Our team and partners stand ready to deliver upon receipt of FDA EUA.”
