Microbix COVID-19 QAPs Attain EU "CE mark" Registration

MISSISSAUGA, Ontario, June 05, 2020 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, Microbix®), an award-winning life sciences innovator and exporter, is pleased to announce the attainment of European Union “CE mark” (Conformité Européene) registration for its SARS-CoV-2 quality assessment products (QAPs™) – CE mark registration enables Microbix’s network of distributors that now covers 18 EU countries to immediately begin providing these products to clinical laboratories across the EU.

Microbix has attained CE marking in compliance with the European In-Vitro Diagnostic Devices Directive (98/79/EC). Complying with Italian requirements for implementation of the Directive, Microbix has also obtained the National Registration with the Italian Ministry of Health. This permits sale of its SARS-CoV-2 Positive and Negative Controls throughout the countries where Microbix has EU-compliant distribution and quality agreements. At present, that comprises the following EU and Nordic countries, with one outlier in that, unlike the other 17, registration is not yet completed for REDxTM brand controls in Latvia:

It has been widely reported that recently-deployed tests for the virus causing COVID-19 disease can provide results of questionable accuracy – “false negative,” or “false positive” results. The four Microbix SARS-CoV-2 QAPs (+ & - swabs or vials) are to increase the reliability of nucleic-acid test (NAT) results.

The Microbix COVID-19 QAPs have been shown to work with multiple NAT methods used to detect the SARS-CoV-2 virus that causes COVID-19 disease, specifically tests targeting a variety of nucleic-acid targets across the genome of the virus. These Microbix products are being made available as REDx™FLOQ® SARS-CoV-2 for swabs, and as REDx™ SARS-CoV-2 for liquid aliquots (vials).

Cameron Groome, President and CEO, stated, “We’re pleased to have completed the process of registering our SARS-CoV-2 Controls to permit their sale as controls to clinical labs across the EU. Microbix’s distributors will now engage with European governments, health authorities, hospitals and laboratory chains, to make certain that EU healthcare systems can benefit from these Microbix products.”

About Microbix Biosystems
Microbix develops proprietary biological and technology solutions for human health and well-being, with approximately 80 skilled employees and sales now 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 enable the antibody tests of over 100 international diagnostics companies, while its QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in 22 countries, distributed by Alpha-Tec Systems, Inc., Diagnostic International Distribution S.p.A., Labquality Oy, The Medical Supply Company of Ireland, and R-Biopharm AG. Microbix is ISO 9001 and 13485 accredited, FDA and Health Canada establishment licensed, and provides CE marked products.

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.

Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of the COVID-19 QAPs, the utility or consequences of use of the COVID-19 QAPs, references to external collaborators and regulators or regulatory processes, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its corporate presentation, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital and raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this news release, and the Company is under no obligation to update or alter any forward-looking information.

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Copyright © 2020 Microbix Biosystems Inc.
Microbix®, Kinlytic®, PROCEEDx™, QAPs™, and REDx™ Controls are trademarks of Microbix Biosystems Inc.
REDx™FLOQ® is a trademark of Microbix Biosystems Inc. in cooperation with COPAN Italia SPA