Baby steps submitted an application to an independent Research Ethics Board ("REB") for approval to conduct a clinical study with the Company's AcuVid TM rapid antigen test for detecting SARS CoV-2 virus in saliva. Approval is expected within a week, at which point Therma will submit a complete package, including the REB review, to Health Canada to conduct the clinical trial.
The data generated from this pivotal clinical study will also be used to support Therma's European Union CE mark submission to be initiated shortly. The CE mark will allow sales of the product in Europe and in other countries where a CE mark is required.
Mr. Rob Fia, CEO of Therma Bright, commented, "We are pleased to cross another hurdle in the process to get AcuVid TM to market. Performance of the test during the development stage has exceeded our expectations. We are in the process of seeking initial product orders, subject to final regulatory approvals and manufacturing scale up."