Mr. Cameron Groome reports

MICROBIX LAUNCHES NEW PRODUCTS TO SUPPORT H3N2 FLU TESTING

Microbix Biosystems Inc. has commercially launched QAPs (quality assessment products) and QUANTDx reference materials to support antigen or molecular tests for H3N2 strains of seasonal influenza A.

H3N2, alongside H1N1, is a common type of influenza A that circulates annually, with H3N2 more prone to antigenic drift, changing the surface of the virus and its level of recognition by antibodies. These changes can reduce the level of protection natural immunity and vaccine-induced immunity normally provide. Additionally, antigenic drift may reduce the accuracy of antigen test assays for flu, which can negatively affect disease management by public health agencies and treatment decisions by health care providers.

A new variant of H3N2 (subclade K) is emerging as the dominant virus for the 2025/2026 flu season. This has been widely reported in the media as being linked to an early start to this year's flu season in the northern hemisphere. Accordingly, laboratories and test developers should ensure that all assays in use can reliably detect H3N2 variants of influenza A within the current multiplex respiratory panels -- whether antigen based or molecular (for example, PCR (polymerase chain reaction) based). This need can now be met using Microbix SARS-CoV-2/Flu A (H3N2)/Flu B/RSV QAPs, available on Copan FLOQSwabs. These QAPs provide multiyear room-temperature stability and complement the existing Microbix respiratory four-plex formulation containing H1N1 flu A, together creating a portfolio tailored to the current epidemiological landscape.

Specifically, Microbix's respiratory QAPs formulated with H3N2 can be used as safe, reliable and stable mimetics of patient samples for training of persons administering tests, validation of new testing sites and verification of instrument/assay performance. Depending on the nature of their needs, users can select either PROCEEDx (research use only) or REDx (in vitro diagnostic) variants of these QAPs.

Upon request, H3N2 reference materials can also be made available, as part of Microbix's QUANTDx product line. QUANTDx products are well characterized, accurately quantified and fully traceable reference materials that enable assay developers to establish key analytical performance metrics -- such as LoD (limit of detection), sensitivity (positive accuracy) and specificity (negative accuracy) -- knowledge that is essential for validation and regulatory submissions.

Cameron Groome, chief executive officer and president of Microbix, commented: "We believe it's critical that Microbix creates QAPs for emerging infectious diseases in a timely manner. Effective public health responses to all outbreaks are predicated on accurate and reliable, tracking, screening and diagnosis -- needs that are imperiled when quality management tools to support testing aren't readily available. It is Microbix's privilege to be a Canadian-led company that is improving health care outcomes worldwide with Ontario-made products."

Further information about QAPs and QUANTDx is available on Microbix's website, while purchase enquiries for QAPs or QUANTDx can be e-mailed to customer.service@microbix.com.

About Microbix Biosystems Inc.

Microbix Biosystems creates proprietary biological products for human health, with over 120 skilled employees and revenues of $25.4-million in its latest fiscal year (2024). 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 accreditation organizations, diagnostics companies and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of international distributors. Microbix is ISO 9001 and ISO 13485 accredited, U.S. FDA (U.S. Food and Drug Administration) registered, Australian TGA (Therapeutic Goods Administration) registered, and Health Canada establishment licensed, and it provides IVDR-compliant (In Vitro Diagnostic Medical Devices Regulation) CE-marked (Conformite Europeenne) 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 is headquartered in Mississauga, Ont., Canada.

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