Therma Bright Inc (TSX-V:THRM, OTC:TBRIF) said it is on track to receive the US Food and Drug Administration's (FDA) approval for its AcuVid coronavirus (COVID-19) Rapid Antigen Saliva test.
The Toronto-based company said it had responded to FDA’s questions and suggestions, while also completing additional documentation and lab tests required by the federal agency.
"We are on track to make AcuVid™ the first COVID-19 Rapid Antigen Saliva Test to receive FDA approval. 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.
READ: Therma Bright interacts with US FDA on emergency use submission for its AcuVid COVID-19 Rapid Antigen Saliva Test
The biotech firm added that it has identified three clinical study sites to conduct a point-of-care clinical performance study. This will complement the completed Brazilian clinical study data that was previously shared with the FDA.
The study will initiate patient screening and recruitment immediately after receiving an Institutional Review Board (IRB) approval, expected in the coming days. Based on current infection rates, Therma Bright expects the study to meet its primary endpoints in approximately two to three weeks.
Therma Bright is a progressive medical diagnostic and device technology company focused on providing consumers and medical professionals with innovative solutions that address important medical and healthcare challenges.
The company also received a Class II medical device status from the 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.
Contact Ritika at ritika@proactiveinvestors.com