MISSISSAUGA, ON / ACCESS Newswire / January 7, 2026 / Microbix Biosystems Inc. (TSX:MBX)(OTCQX:MBXBF) (Microbix), a life sciences innovator, manufacturer, and exporter, announces the commercial usage of its first recombinant antigen product, the nucleocapsid protein of the SARS-CoV-2 virus (COVID-19), in its quality assessment products ("QAPs") and its availability 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 (i.e., synthetic) antigen production to complement its longstanding 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 or external quality assessment programs ("PT" or "EQA"), and is being incorporated into PROCEEDx (RUO) and REDx (IVD) branded QAPs used to support ongoing 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 an ongoing 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 totaled C$ 5.6 million across fiscal 2025).
Dr. Mark Luscher, SVP of Scientific Affairs, highlights the relevance of the Microbix recombinants 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 at https://microbix.com, while purchase enquiries 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$ 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 & 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 or medial 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 antigen or QAPs 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.
Please visit https://microbix.com or https://www.sedarplus.ca for recent Microbix news and filings.
For further information, please contact Microbix at:
Cameron Groome, CEO | Jim Currie, | Deborah Honig, |
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Copyright © 2026 Microbix Biosystems Inc.
Microbix, DxTM, Kinlytic, PROCEEDx, QAPs, QUANTDx, and REDx are trademarks of Microbix Biosystems Inc.
SOURCE: Microbix Biosystems Inc.
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/business-and-professional-services/microbix-commercializes-sars-cov-2-covid-recombinant-antigen-for-1124522
