- Ontario-based Microbix Biosystems (TSX:MBX) has received its medical devices establishment licensing from Health Canada
- The license enables the immediate use of the company’s quality assessment products (QAPs) by clinical laboratories across Canada
- It’s hoped that the QAPs will be able to increase the accuracy of current COVID-19 testing methods
- The company says that initial QAPs can be shipped as early as April 30 this year
- Microbix Biosystems (MBX) is currently up 19.64 per cent to C$0.34 per share, with a market cap of $36.43 million
Ontario-based Microbix Biosystems (TSX:MBX) has received its medical devices establishment licensing from Health Canada.
Receipt of the license now allows for the immediate usage of the company’s quality assessment products (QAPs) by clinical laboratories across Canada, including those designed to improve the accuracy of current COVID-19 tests.
Microbix alleges that recently deployed tests for the virus are providing results of questionable accuracy. The company said that some results have given false-negative or false-positive indications.
The COVID-19 QAPs are provided as whole-genome workflow support tools and include 100 per cent of the virus’s genetic sequence. They have been shown to emulate real patient samples while being consistent, non-infectious and stable.
Cameron Groome, President and CEO of Microbix Biosystems, thanked Health Canada for its prompt review of the application, which was lodged on April 13.
“Such prompt action is precisely what is needed to get leading-edge tools like Microbix’s QAPs into the hands of Canada’s front-line healthcare providers.
“Microbix will now engage with procurement authorities in Ontario and other provinces and territories to make certain that Canadians can benefit from Microbix’s products that help to ensure test accuracy,” he said.
Currently, Microbix has the capacity to produce 5,000 units per week, as well as a further 10,000 per week in a liquid vial form. The company says that these can be shipped as early as April 30 this year to support the verification of new testing methods.
Microbix was quick to point out that, at a usage rate of one QAP unit for every 100 tests, the company would be able to ensure the accuracy of 1.5 million COVID-19 tests per week.
Microbix Biosystems (MBX) is currently up 19.64 per cent to C$0.34 per share at 3:08pm EST.
