Microbix Launches QUANTDx™ Characterized Reference Materials

New Product Line Supporting Diagnostic Assay Manufacturers

 

MISSISSAUGA, CANADA, July 29, 2025 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces the commercial launch of QUANTDx™, a new product line of well-characterized reference materials designed to support the development and validation of diagnostic assays. QUANTDx is being launched at ADLM 2025, the conference of the Association for Diagnostic & Laboratory Medicine being held in Chicago, USA July 28-31, at which Microbix is exhibiting.

 

The QUANTDx product line features 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) —that are essential for regulatory submissions and validation. The initial QUANTDx launch includes over 80 such reference materials that cover six of the most commonly tested disease panels, namely the following types of infections — fungal, human papillomaviruses, gastrointestinal, meningitis, respiratory, and sexually-transmitted. This comprehensive product line addresses a critical need within the infectious disease diagnostics industry for high-quality, reliable, and standardized reference materials.

 

QUANTDx complements Microbix’s established Quality Assessment Products (QAPs™) portfolio, which includes the industry-recognized PROCEEDx™ (RUO) and REDx™ Controls (IVD) products. Together, these product lines address a broad spectrum of quality-related needs across the diagnostic development lifecycle—from assay design, validation, and quality release through to end-user training and ongoing quality control. This holistic support reinforces Microbix’s role as a trusted partner to the global diagnostics industry.

 

Cameron Groome, CEO & President of Microbix, commented, “The launch of QUANTDx represents a strategic expansion of our capabilities to serve assay developers and clinical laboratories. By leveraging our in-house portfolio of organisms and expertise in nucleic acid quantification, we are confident in delivering reliable and reproducible reference materials to streamline assay development and validation.”

 

Phil Casselli, SVP of Sales and Business Development at Microbix, added, “We are thrilled by the support we’ve received from prospective customers for QUANTDx. It’s clear that there is strong, unmet demand for high-quality, and fully-quantified reference materials across the diagnostics industry. We believe this launch will provide Microbix with more opportunities to support assay developers, clinical labs, and manufacturers worldwide. We fully expect QUANTDx™ to drive revenue growth and expand our global customer base.”

 

Further information about QUANTDx is available at https://microbix.com/products/reference-materials/, while purchase enquiries for 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 targeting C$ 2.0 million or more per month. It enables the worldwide commercialization of diagnostic assays by making 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 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 the QUANTDx product line or its 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 www.microbix.com or www.sedarplus.ca for recent Microbix news and filings.

 

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

 

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Microbix®, DxTM®, Kinlytic®, PROCEEDx®, QAPs™, and REDx® are trademarks of Microbix Biosystems Inc.

PROCEEDx®FLOQ® and REDx®FLOQ® are trademarks of Microbix in collaboration with Copan Italia S.p.A.

COPAN®, FLOQ®, and FLOQSwab® are trademarks of Copan Italia S.p.A.