Therma Bright turns attention to rapid COVID-19 testing amid rising demand
The Toronto-based company recently filed its US FDA application for Emergency Use Authorization approval to market its AcuVid test
Company
Therma Bright Inc
CVE:THRM
Therma Bright Inc, the developer of the AcuVid COVID-19 Rapid Antigen Saliva Test, is a progressive medical diagnostic and device technology company focused on providing consumers and medical professionals with quality, innovative solutions that address some of today’s most important medical and healthcare challenges. The company’s initial breakthrough proprietary technology delivers effective, non-invasive and pain-free skincare. Therma Bright has received a Class II medical device status from the US Food & Drug Administration (FDA) for its platform technology that is indicated for the relief of the pain, itch, and inflammation of a variety of insect bites or stings. The company received clearance for the above claims from the US FDA in 1997.
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Therma Bright inks deal to boost production of AcuVid COVID-19 tests to meet FDA guidance
The company said the contract manufacturer, a European ISO 13845 certified company, will produce a weekly minimum of 500,000 AcuVid COVID-19 Rapid Antigen Saliva tests
Therma Bright to begin US clinical performance study of its AcuVid COVID-19 Rapid Antigen Saliva Test
"Therma Bright can begin moving forward in our efforts with three pre-selected U.S. clinics. Based on current COVID-19 infection rates, we expect the study results to be delivered to the FDA within the next few weeks, as part of our AcuVid
Therma Bright says 'on track' for FDA approval of its COVID-19 rapid antigen saliva test, AcuVid
"Our robust bench tests and clinical performance results, provide us with confidence that we will be able to bring a viable solution to limit the spread of this virus in our communities," said Rob Fia, CEO of Therma Bright.
Therma Bright interacts with US FDA on emergency use submission for its AcuVid COVID-19 Rapid Antigen Saliva Test
CEO Rob Fia said “we continue to build manufacturing capacity for our test in anticipation of approval so that we can meet the expected huge demand for rapid testing”