Mr. Cameron Groome reports
MICROBIX ATTAINS HEALTH CANADA ESTABLISHMENT LICENSING
Microbix Biosystems Inc. 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 the 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 100 tests, such QAPs can help ensure the accuracy of 1.5 million COVID-19 tests per week.
Cameron Groome, president and chief executive officer, stated: "We thank Health Canada for its review and acceptance of the application provided by Microbix 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 health care 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 the 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.
As for all Microbix QAPs, these COVID-19 QAPs are whole-genome workflow support tools that include 100 per cent 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-labelled 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, Food and Drug Administration registered, and CE mark certified Redx controls or RedxFLOQ brand QAPs.
About Microbix Biosystems Inc.
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 that support clinical lab proficiency testing, enable assay development and validation, or help ensure quality control of clinical diagnostic tests.
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