Mr. Cameron Groome reports

MICROBIX COMMERCIALIZES SARS-COV-2 (COVID) RECOMBINANT ANTIGEN FOR USAGE IN QAPS AND TEST MANUFACTURING

Microbix Biosystems Inc. has commercialized the usage of its first recombinant antigen product, the nucleocapsid protein of the SARS-CoV-2 virus (COVID-19), in its quality assessment products (QAPs). The product is available at commercial scale for test manufacturers.

This is the first commercial product to emerge from the development program announced in January, 2025, whereby Microbix committed to extend its capabilities into recombinant (that is, synthetic) antigen production to complement its long-standing expertise in native antigen production. This internally made recombinant antigen has been developed, manufactured at commercial scale and fully validated. Accordingly, it is now being used in Microbix's QAPs to support clinical laboratory proficiency testing (PT) or external quality assessment (EQA) programs and is being incorporated into PROCEEDx- (research use only) and REDx-branded (in vitro diagnostics) QAPs used to support continuing quality management of clinical laboratories or other testing sites.

Microbix has 40 years of expertise in the technically challenging manufacturing of native viral antigens, which requires culturing of mammalian host cells, the addition and growth of target viruses in those cells, and, finally, the extraction, purification and inactivation of high-quality components for infectious-disease tests in commercial quantities. That expertise is now joined by a newly demonstrated ability to make recombinant/synthetic antigens, which when appropriately designed and manufactured can substitute for native antigens in suitable contexts. Additionally, in-house recombinant production improves Microbix's supply chain security and enables better control of costs, which is intended to help Microbix remain a leading supplier of QAPs to clients in the PT/EQA, test manufacturing and clinical laboratory fields.

Since its emergence as a novel pandemic in 2019, SARS-CoV-2 has become endemic worldwide. Accordingly, there is a continuing market in antigen-based testing for this virus. Microbix's SARS-CoV-2 antigen QAPs support quality assessment needs related to such testing and comprise a meaningful proportion of overall QAPs sales (which totalled $5.6-million across fiscal 2025).

Dr. Mark Luscher, senior vice-president of scientific affairs, highlights the relevance of the Microbix recombinant program: "Our teams have deep expertise in making antigen products that have the properties needed to measure and characterize the disease response in human populations -- the key to both diagnostic test design and EQA. Our dedicated scientists now have both established a recombinant platform and built our first such commercial product using this powerful technology. With this, we have added yet another tool for delivering on our commitment to meet the demanding technical requirements of the diagnostic industry."

Further information about Microbix QAPs, antigens, reference materials and reagents is available on Microbix's website, while purchase inquiries 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 $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 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 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 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 media to support diagnostic testing (for example, its DxTM for patient-sample collection). Microbix is traded on the Toronto Stock Exchange and the OTCQX market and is headquartered in Mississauga, Ont., Canada.

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