Helping Ensure Workflow Accuracy of Tests for Respiratory Viruses

MISSISSAUGA, CANADA, February 1, 2022 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator and exporter, announces the expansion of its portfolio of Quality Assessment Products (“QAPs™”) to include a swab-formatted control that helps validate the accuracy and integrity of the workflows of nucleic-acid based tests (e.g., “PCR” tests) for SARS-CoV-2 (“COVID”) Wuhan strain and the Omicron variant (“Omicron”) – the latter now being the most prevalent form of COVID.

Specifically, Microbix is commercializing its In-Vitro Diagnostic (“IVD”) quality control to support workflow accuracy of clinical laboratory PCR tests that aim to detect and differentiate SARS-CoV-2 Wuhan strain and Omicron infections. This innovative, proprietary, and branded control provides a fully-compliant, comprehensive, and cost-effective quality management tool to help avoid the systemic errors that can be driven by technicians, consumables, or instruments. Users of this IVD control will include lab accreditation agencies, makers of tests oriented to clinical labs or point-of-care, and clinical labs or medical clinics.

This Microbix Omicron QAP is made using Copan® FLOQSwabs® – the optimal format for accuracy and point-of-care use, and with room-temperature stability for 12 months. As for all Microbix’s QAPs, this latest IVD control contains all possible PCR targets and is validated on multiple test platforms. This new QAPs SKU is labelled REDx™FLOQ® SARS-CoV-2 B.1.1.529 SWAB POSITIVE CONTROL and is now available to support clinical laboratory quality management systems (“QMS”) covering central lab and point-of care workflows in both the U.S. and Canada. Research-Use-Only (“RUO”) PROCEEDx™FLOQ® versions are now available for other markets, with REDx® IVD versions to follow.

Microbix’s QAPs portfolio now consists of over 70 proprietary SKUs in the categories of respiratory, sexually-transmitted, and gastrointestinal infectious diseases. Of that portfolio, 17 QAPs are available as REDx Controls for IVD use by clinical labs. In addition to QAPs to support PCR-based testing for the most important respiratory illnesses, including all major COVID variants, Microbix also has IVD QAPs to support antigen-based respiratory pathogen tests (e.g., REDxFLOQ SARS-CoV-2 Ag). Microbix’s QAPs for PCR-test and Antigen-test support are also available as ONBOARDx™ kits that include both positive and negative controls for convenient qualification of new instruments for clinical use and for the training of laboratory staff. This portfolio of QAPs is in widespread use and can be paired with Microbix’s DxTM™ viral transport medium to enable collection and stabilization of patient test-sample specimens.

Cameron Groome, CEO and President of Microbix, commented “For optimal patient care and public health management, clinicians and lab directors need controls that can provide them justifiable confidence in the accuracy and reliability of their testing programs. Microbix’s suite of QAPs to support testing for respiratory pathogens is providing that essential support, driven by our ability to quickly respond to the emergence of new viruses or variants with pandemic-generating potential. We are pleased to add this Omicron-oriented QAP to maintain our complete coverage of all major COVID variants.”

About Microbix Biosystems

Microbix develops proprietary biological technology solutions for human health and well-being, with about 100 skilled employees and sales nearing C$ 2.0 million per month. 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 the quality of clinical diagnostic workflows. 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 over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, R-Biopharm AG, SDT Molecular Pte Ltd,  Seegene Canada Inc., and Thomas Scientific LLC. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, 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 viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, 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 QAPs and their relevance or timing, 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 new release, and the Company is under no obligation to update or alter any forward-looking information.

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Copyright © 2022 Microbix Biosystems Inc.     

Microbix®, DxTM™, Kinlytic®, ONBOARDx™, PROCEEDx®, QAPs™ and REDx® are trademarks of Microbix Biosystems Inc.

PROCEEDx™FLOQ® and REDx™FLOQ® are trademarks of Microbix Biosystems Inc. in collaboration with Copan Italia S.p.A.

Copan®, FLOQ®, and FLOQSwab® are trademarks of Copan Italia S.p.A.