MISSISSAUGA, Ontario, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces the commercial launch of QAPs™ quality assessment products and availability of QUANTDx™ reference materials to support antigen or molecular tests for H3N2 strains of seasonal Influenza A (a.k.a., the “Flu”).
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 healthcare providers.
A new variant of H3N2 (subclade K) is emerging as the dominant virus for the 2025/26 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 (e.g., PCR-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 multi‑year 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® (RUO) or REDx® (IVD) 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, CEO & 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 healthcare outcomes worldwide with Ontario Made products.”
Further information about QAPs and QUANTDx is available at https://microbix.com, while purchase enquiries for QAPs or QUANTDx can be e-mailed to customer.service@microbix.com.
About Microbix Biosystems Inc.
Microbix Biosystems Inc. creates proprietary biological products for human health, with over 120 skilled employees and revenues of C$ 25.4 million in its latest reported 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 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment 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 to support diagnostic testing (e.g., its DxTM™ for patient-sample collection). 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 the H3N2 products or their relevance, Microbix’s or others’ products or services, business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its presentations, regulatory compliance and approvals, access and sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity or timeliness of delivery), currency exchange rates, maintaining adequate working capital or raising new capital on acceptable terms or at all, and other similar statements about 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. Microbix cautions that all forward-looking information is inherently uncertain and actual performance may be affected by many material factors, some of which are beyond its 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 Microbix’s judgement as of the date of this new release, and it is under no obligation to update or alter any forward-looking information except as required by applicable law.
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For further information, please contact Microbix at:
| Cameron Groome, CEO (905) 361-8910 | Jim Currie, CFO (905) 361-8910 | Deborah Honig, Investor Relations Adelaide Capital Markets (647) 203-8793 ir@microbix.com |
Copyright © 2025 Microbix Biosystems Inc.
Microbix®, DxTM®, Kinlytic®, PROCEEDx™, QAPs™, QUANTDx™, and REDx™ are trademarks of Microbix Biosystems Inc.
Copan®, FLOQ®, and FLOQSwab® are trademarks of Copan Italia S.p.A.
