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Therma Bright Reports Performance of Its AcuVid(TM) COVID-19 Rapid Antigen Saliva Test from Brazilian Clinical Study
Toronto, Ontario--(Newsfile Corp. - June 17, 2021) - Therma Bright Inc. (TSXV: THRM) ("Therma"...
About this update from Therma Bright Inc.
[{"type":"text","content":"Therma Bright Reports Performance of Its AcuVid(TM) COVID-19 Rapid Antigen Saliva Test from Brazilian Clinical StudyToronto, Ontario--(Newsfile Corp. - June 17, 2021) - Therma Bright Inc. (TSXV: THRM) (\"Therma\" or the \"Company\"), developer of the AcuVid™ COVID-19 Rapid Antigen Saliva Test and a progressive medical device technology company, is pleased to provide an update on the exceptional performance of its AcuVid™ COVID-19 Rapid Antigen Saliva Test's Brazilian Clinical Study, conducted in Minas Gerais, Brazil.\"The ongoing clinical study for our AcuVid™ COVID-19 Rapid Antigen Saliva Test has performed extremely well,\" expressed Therma's CEO Rob Fia. \"As of June 16th, 63 subjects were enrolled and provided a nasal swab for a RT-PCR test and a saliva sample for the AcuVid™ test. Of the 63, RT-PCR results were received for 56 subjects, with 28 positive and 28 negative results. The RT-PCR results for the other 7 subjects will be received in the coming days. The AcuVid™ test demonstrated a 100% specificity for the RT-PCR negative samples. Of the 28 positive RT-PCR results, the AcuVid™ test had a 100% sensitivity for RT-PCR results with a Ct values below 27.\"Currently, the Company is waiting on final results from 7 additional test subjects from the 63 total valid individuals in the clinical study, and who provided both a nasal swab for a RT-PCR test and a saliva sample. The RT-PCR and Ct results for the remaining 7 test subjects will be matched against their AcuVid™ rapid test. The Company anticipates achieving the 30 positive/30 negative requirements for FDA Emergency Use Authorization (EUA) application and will submit when all final results are received, and final documentation is ready. Furthermore, Therma plans to continue the clinical study in Brazil beyond the initial requirements, should any regulatory body require additional test data of the AcuVid™ COVID-19 Rapid Antigen Saliva Test. \"We're extremely pleased with the performance of the AcuVid™ test and its 100% sensitivity for Ct values below 27, as well as the 100% specificity,\" shared Dr. Ricardo Fujiwara, the Principal Investigator for the study at the Federal University of Minas Gerais. \"Patients with Ct values below 27 are usually in the early phases of this viral infection and are the most conta...