- Therma Bright (THRM) has announced results from its ongoing its AcuVid COVID-19 rapid antigen saliva test’s Brazilian clinical study
- As of June 16, 63 subjects have been enrolled in the study and provided a nasal swap for an RT-PCR test and a saliva sample for the company’s AcuVid test
- RT-PCR results were received for 56 subjects with 28 positive and 28 negative results
- The AcuVid test demonstrated 100 per cent specificity for the RT-PCR negative samples
- The AcuVid test also had 100 per cent sensitivity for 28 of the positive RT-PCR results for Ct values below 27
- Shares of Therma Bright were up 1.30 per cent to C$0.39 as of 4:00 p.m EDT
Therma Bright (THRM) has announced results from its ongoing AcuVid COVID-19 rapid antigen saliva test’s Brazilian clinical study.
As of June 16, a total of 63 subjects were enrolled after providing a nasal swab for an RT-PCR test and saliva sample for the AcuVId test.
Out of those 63, RT-PRC results were received for 56 subjects, with 28 positive and 28 negative results.
Results for the seven other subjects will be received in the coming days.
Meanwhile the AcuVid test showed 100 per cent specificity for the RT-PCR negative samples. For the 28 positive RT-PCR results, the AcuVid had 100 per cent sensitivity with Ct values under 27.
“We’re extremely pleased with the performance of the AcuVid™ test and its 100 per cent sensitivity for Ct values below 27, as well as the 100 per cent specificity,” Dr. Ricardo Fujiwara, the Principal Investigator for the study at the Federal University of Minas Gerais, said in the release.
“Patients with Ct values below 27 are usually in the early phases of this viral infection and are the most contagious. Not only is it important, but also critical, to identify these patients as quickly and accurately as possible to mitigate spread.”
The RT-PCR and Ct results from the final seven subjects will be compared to their AcuVid rapid test.
Therma Bright anticipates meeting the 30 positive/30 negative requirements for its FDA Emergency Use Authorization application.
“This is a significant achievement for Therma Bright and our AcuVid™ COVID-19 Rapid Antigen Saliva Test,” Rob Fia, Therma Bright CEO , said in a press release. “Not only will this clinical data be used for our FDA EUA application submission, but we will also be submitting this clinical data in our Health Canada, ANVISA (Brazil) and INVIMA (Colombia) filings, as well as it will be used to further support our recent CE approval received in April 2021.”
Following the testing, the company will submit its application when all results are received and documentation is prepared and ready.
Therma Bright’s AcuVid COVID-19 rapid antigen saliva test was designed specifically to allow people to collet their own saliva in a collection tube.
This helps reduce the risk of COVID-19 infection and transmission to healthcare workers involved in sample collection and testing.
Shares of Therma Bright were up 1.30 per cent to C$0.39 as of 4:00 p.m EDT.
