Mr. Cameron Groome reports

MICROBIX QUALIFIES AS SUPPLIER FOR FIVE MAJOR DX TEST-MAKERS PRODUCT LINES FOR SUPPORT OF LEADING IVD MANUFACTURERS

Microbix Biosystems Inc. has completed formal qualification to become a supplier for five in-vitro diagnostics (IVD) manufacturers (Dx test makers). Each of these five Dx test makers are considered to be one of the 10 largest such companies by revenues, and Microbix is pleased to have successfully completed their supplier audit and quality review processes.

Clearing these detailed and multifaceted supplier qualification processes permits Microbix to supply critical products to these Dx test makers, across its antigens, QAPs, ONBOARDx kits, QUANTDx reference materials and reagents. In multiple instances, these processes have involved multiday on-site audits of Microbix's manufacturing, quality control, quality assurance, ISO compliance and other business systems.

Formal supplier qualification does not guarantee that Microbix will be awarded material contracts from these five Dx test makers. However, it should ensure that opportunities for such business will be more available to Microbix when new projects arise. Additionally, being recognized as a fully vetted supplier by such large and respected Dx test makers may help Microbix secure business with smaller diagnostics companies that lack the resources to conduct such rigorous supplier qualification processes.

Microbix believes major Dx test makers do not typically commit resources to audit and qualify new suppliers without a clear business reason. While respecting all confidentiality provisions, the company can states their actions generally reflect interest in one or more of the following Microbix products or product lines:

• Antigens. Purchase of Microbix's native or recombinant antigens to enable the production of tests for assessing prior exposure to, immunity from, or an acute reaction to, an infectious pathogen.
• QAPs. Purchase of one or more of Microbix's QAPs patient-sample mimetics as in-kit test-controls to help ensure the accuracy of lab-based or point-of-need infectious-disease tests.
• ONBOARDx kits. Purchase of customized kits of Microbix QAPs to assist with qualifying new testing sites and for the initial and periodic training of technicians at those sites.
• QUANTDx. Purchase of well-characterized and quantified QUANTDx reference materials to assist with new assay development and as QC release standards for the manufacture of assays.

Cameron Groome, chief executive officer and president of Microbix, commented: "Focus on 'customer success' is helping us join our team with those of our clients -- from initial assay concept through to full commercialization. We're grateful to have been invited to undertake these qualification processes and are pleased to have successfully concluded them. I commend the Microbix team for positively supporting due diligence by five major firms and we certainly aim to secure and disclose new business with one or more of them."

About Microbix Biosystems Inc.

Microbix Biosystems creates proprietary biological products for human health, with 120 skilled employees and revenues of $18.6-million in its latest fiscal year (2025). It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs) and reference materials (QUANTDx) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs or QUANTDx are sold to clinical lab PT/EQA organizations, diagnostics companies and clinical labs. Microbix QAPs are now available in over 30 countries, supported by international distributors. Microbix is ISO 9001 and 13485 accredited, U.S. Food and Drug Administration registered, Australian TGA registered, Health Canada licensed and provides IVDR-compliant 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, and reagents or medial to support diagnostic testing (for example, its DxTM for patient-sample collection). Microbix is traded on the Toronto Stock Exchange and OTCQX, and headquartered in Mississauga, Ont., Canada.

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