Therma Bright Inc (TSX-V:THRM, OTC:TBRIF) revealed that it has completed the US Clinical Performance Study's subject recruitment effort for its AcuVid coronavirus (COVID-19) Rapid Antigen Saliva Test and is waiting for final RT-PCR results to match against each test subject's AcuVid test result.
The Toronto-based medical diagnostic and device technology company, which has developed the smart-enabled AcuVid COVID-19 Rapid Antigen Saliva Test, said that once the clinical data has been tabulated, the final results will be filed with the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) consideration.
"We appreciate the continued patience of our clients, shareholders, and partners while we await the final COVID-19 RT-PCR tests from our clinic partner's labs," Therma Bright CEO Rob Fia said in a statement.
"The FDA closely regulates these types of scientific studies that are designed to develop evidence that support the safety and effectiveness of investigational medical devices and diagnostic tests and we are confident that our AcuVid US Clinical Performance Study will meet the EUA’s rigorous review. We will submit the US Clinical Performance Study data to the FDA once it is collected and tabulated."
The Therma Bright boss noted that antibodies in its AcuVid COVID-19 Rapid Antigen Saliva Test can successfully detect the relatively new 'stealth Omicron' variant, BA.2, which has been in the news.
“Although preliminary indications are that it is no more contagious or virulent than the original Omicron variant, it may become the dominant variant in certain countries in coming months,” added Fia. “We are confident that our test will detect stealth Omicron and are currently confirming that with our partners."
To date, Therma Bright said its AcuVid saliva test solution has successfully detected not only the original Wuhan SARS-CoV-2 coronavirus, but other WHO variants of concern, including the P.1 and P.2 variants discovered in Brazil, the B.1.1.7 variant from the UK, the highly contagious Delta variant from India, and the Omicron variant from the South Africa region.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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