Microbix Expanding Addressable Market Share with Test Makers Augmenting its Recombinant Antigen Capabilities for Immunoassay Markets

MISSISSAUGA, Ontario, Jan. 08, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix^®), a life sciences innovator, manufacturer, and exporter, announces its intentions to broaden its platform capabilities to enable production of a wider range of test ingredients (“Antigens”) by using recombinant production technologies. Directing existing in-house synthetic biology capabilities to this project will create large-scale recombinant Antigens production to complement and expand Microbix’s addressable market share as a key supplier to manufacturers of immunoassays – the class of diagnostic tests that establishes exposure to, or immunity from, pathogens.

Microbix has been a leading producer of purified and inactivated Antigens from native (natural) bacterial and viral organisms for more than three decades. It supplies these critical biological ingredients to more than 100 international manufacturers of immunoassays where test accuracy is maximized by using such Antigens. Microbix’s sales of native Antigens totaled C$ 13.8 million in fiscal 2024, an increase of 44% from the prior year and generated from a catalogue of dozens of these complex and valuable biomaterials.

However, to date Microbix has not broadly participated in making Antigens using the recombination of genetic materials from different species (i.e., “recombinant” technologies). Such recombinant Antigens can have price advantages relative to native Antigens and are the choice of immunoassay makers in situations where they can be used without sacrificing assay performance. Microbix offering recombinant Antigens will increase the extent to which it can grow sales of this important segment of its business.

Microbix has therefore decided to fund the augmentation of its internal capabilities in synthetic biology in order to build the processes and capacity for production of recombinant Antigens. This will entail adding trained staff, equipment, biological vectors, and cell-lines. With the infrastructure and capabilities already built-out over the past several years, the incremental investment needed to drive the opening of these new market opportunities will be modest, at about C$ 0.5 million per year.

Cameron Groome, CEO & President of Microbix, commented, “With our improved financial position and greater internal capabilities, we are now moving to fully resource a recombinant antigens program. By year-end 2025, this initiative will increase our total addressable market by way of providing existing and new customers with a broader range of infectious-disease antigens and at a variety of price points.”

Dr. Ken Hughes, COO of Microbix, also commented, “Few, if any, companies have keener insight than Microbix regarding how recombinant antigens must perform to effectively emulate their native versions, which will provide material benefits to our test-maker clients. Additionally, we will use our recombinant antigens as ingredients for our QAPs^® test-controls – providing an immediate internal client to provide performance validation for external customers while also strengthening our supply chain.”

Purchase enquiries for Microbix Antigens can be e-mailed to .

About Microbix Biosystems Inc.

Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and sales now targeting C$ 2.0 million or more per month. It makes and exports a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) 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 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 media to support molecular 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 recombinant Antigen plans 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, 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 a number of material factors, many 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.

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