Microbix Attains Health Canada Establishment Licensing

Enables Immediate Usage of SARS-CoV-2 Controls by Clinical Labs across Canada

MISSISSAUGA, Ontario, April 21, 2020 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, Microbix), a life sciences innovator and exporter, announces that it has attained medical devices establishment licensing from Health Canada, enabling the immediate usage of its quality assessment products (QAPs) by clinical laboratories, including its QAPs to help ensure the accuracy of COVID-19 disease testing.

It has been widely reported that the recently-deployed tests for the virus causing COVID-19 disease are providing results of questionable accuracy – sometimes giving “false negative,” or “false positive” results.  Microbix’s QAPs are designed to increase the reliability of test results and this licensing from Health Canada will allow their use in testing labs across the country.

At present, Microbix has capacity to make 5,000 units per week of room-temperature stable COVID-19 QAPs exclusively on COPAN FLOQSwabs, and 10,000 units per week in a liquid vial format. Such QAPs can be shipped as early as April 30 to support the verification of new testing methods, the validation of newly-placed test instruments, training of technicians, lab proficiency accreditations, and by clinical labs for systematic quality control.  By way of example, at usage of one per hundred tests, such QAPs can help ensure the accuracy of 1.5 million COVID-19 tests per week.

Cameron Groome, President and CEO, stated, “We thank Health Canada for its review and acceptance of the application provided by Microbix on April 13th. 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.”

The Microbix COVID-19 QAPs have been shown to work with multiple nucleic-acid based test (NAT) methods used to detect the SARS-CoV-2 virus that causes COVID-19 disease, specifically those targeting E, N, and RdRP genes, and on protocols requiring human RP housekeeping gene presence.  These Microbix products are being made available as REDxFLOQ SARS-CoV-2 for swabs, and as REDx SARS-CoV-2 for liquid aliquots.