Trimedic Therapeutics has submitted to Health Canada an application for the importation and sale of its COVID-19 rapid antigen test under the Interim Order pathway.
TORONTO, Oct. 27, 2020 /CNW/ - Trimedic Therapeutics has submitted to Health Canada an application for the importation and sale of its COVID-19 rapid antigen test under the Interim Order pathway. According to the Toronto based pharmaceutical and diagnostics company, the submission was made on October 1 following the completion of an independent clinical study that showed the test was able to perform equal to, or better than, similar devices currently approved for use in Canada.
The COVID-19 rapid antigen test is a point-of-care cassette that does not require lab instruments or specialized lab personnel to be performed. It can be administered by healthcare professionals easily. The test can help identify infected individuals in 15 minutes and is designed for point-of-care settings such as prisons and long-term care facilities. The assay is approved in Europe and has recently been submitted to the FDA for approval in the US.
The rapid antigen test uses lateral flow technology to detect the presence of the COVID-19 virus in upper respiratory sample collected by swab. Clinical data carried out in the United States shows 94.3% sensitivity and 98.3% specificity compared with lab results done by Real-Time PCR. This data was confirmed by a major US clinical reference lab.
Edward Mamenta, Ph.D., who oversees product validation for Trimedic, said “We are extremely pleased with the results shown in the LabCorp study. From the outset, Trimedic has been committed to ensuring that product quality would not be compromised by the need to get these tests out to the public as quickly as possible”.
As Trimedic waits for the response to its Health Canada submission, the company is actively preparing to meet the anticipated high demand for rapid antigen testing in the upcoming months (when experts predict a significant surge in COVID-19 infections). John Boyack, Head of point-of-care diagnostics at Trimedic, noted “We expect to be able to deliver one million tests within the first four weeks of receiving Health Canada approval, and up to one million per month thereafter, if necessary”.
SOURCE Trimedic Therapeutics Inc.
