Microbix Biosystems rolls out Quantdx product line

Mr. Cameron Groome reports MICROBIX LAUNCHES QUANTDX CHARACTERIZED REFERENCE MATERIALS Microbix Biosystems Inc. has commercially launched 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, United States, from July 28 to 31, 2025, 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 (research use only) and Redx controls (in vitro diagnostic) products. Together, these product lines address a broad spectrum of quality-related needs across the diagnostic development life cycle -- from assay design, validation and quality release through to end-user training and continuing quality control. This holistic support reinforces Microbix's role as a trusted partner to the global diagnostics industry. Cameron Groome, chief executive officer and 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, senior vice-president 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 on Microbix's website while purchase inquiries for Quantdx can be e-mailed to [email protected]. About Microbix Biosystems Inc. Microbix Biosystems creates proprietary biological products for human health, with over 120 skilled employees and revenues targeting $2-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 and 13485 accredited, U.S. Food and Drug Administration registered, Australian Therapeutic Goods Administration registered, and Health Canada establishment licensed and 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 molecular diagnostic testing (for example, its DxTM for patient-sample collection). Microbix is traded on the Toronto Stock Exchange and the OTCQX exchange and headquartered in Mississauga, Ont., Canada. We seek Safe Harbor.