Microbix Attains Health Canada Establishment Licensing
Enables Immediate Usage of SARS-CoV-2 Controls by
Clinical Labs Across Canada
MISSISSAUGA, CANADA, April 21, 2020 - 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 REDx™FLOQ® SARS-CoV-2 for swabs, and as REDx™ SARS-CoV-2 for liquid aliquots.
As for all Microbix QAPs, these COVID-19 QAPs are whole-genome workflow support tools that include 100% of the genetic sequences of the virus and emulate real patient samples while being consistent, non-infectious, and stable. As such, the COVID-19 QAPs contain all possible NAT viral targets - ensuring compatibility across current and future NATs. This broad compatibility and guaranteed utility is particularly relevant in the context of testing during a pandemic, when multiple test protocols and instrument systems are being newly-called into use.
Microbix supplies a broad range of white-labeled QAPs, including other viral respiratory pathogens, to support the proficiency testing (PT) programs of laboratory accreditation organizations in North America and Western Europe. Under its PROCEEDx™ brand, Microbix provides RUO (research-use-only) QAPs to support the test validation/verification and operator training objectives of test developers and clinical labs. Full QMS support of clinical laboratory patient sample testing is provided by Microbix's Health Canada licensed, FDA registered, and CE mark certified REDx™ Controls or REDx™FLOQ® brand QAPs.
About Microbix Biosystems
Microbix develops proprietary biological and technology solutions for human health and well-being, with approximately 80 skilled employees and sales now usually exceeding $1 million per month on average. It makes a wide range of critical biological materials for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure quality control of clinical diagnostic tests. Microbix antigens and QAPs are sold to many customers worldwide, at present primarily to multinational diagnostics companies and laboratory accreditation organizations.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots.
Microbix is a publicly-traded company, listed on the Toronto Stock Exchange and headquartered in Mississauga, Ontario, Canada.
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