Microbix Biosystems Launches Innovative QUANTDx™ Reference Materials
Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF), a trailblazer in life sciences, has unveiled a groundbreaking product line named QUANTDx™. This range of carefully characterized reference materials aims to enhance the development and validation processes of diagnostic assays. The launch coincides with the ADLM 2025 conference, a significant event where Microbix is showcasing its offerings in Chicago.
Features of the QUANTDx™ Product Line
The QUANTDx™ product line is designed with precision, offering accurately quantified and fully traceable reference materials. These materials are vital for assay developers who need to establish critical performance metrics, including Limit of Detection (LoD), positive accuracy (Sensitivity), and negative accuracy (Specificity). These metrics are particularly important for regulatory submissions and validation processes. Initially, the QUANTDx™ range features over 80 reference materials that encompass six prevalent disease panels, addressing various types of infections, such as fungal, human papillomaviruses, gastrointestinal, meningitis, respiratory, and sexually transmitted infections. By providing a diverse array of high-quality and standardized reference materials, QUANTDx™ meets a crucial demand in the infectious disease diagnostics sector.
Complementing Existing Quality Assessment Products
QUANTDx™ is a valuable addition to Microbix’s well-established Quality Assessment Products (QAPs™) portfolio. This portfolio includes the highly recognized PROCEEDx™ and REDx™ controls, which cater to a diverse range of quality-related needs throughout the diagnostic development lifecycle. From assay design and validation to continuous quality control and user training, the comprehensive support offered by these product lines solidifies Microbix’s position as a trusted partner within the global diagnostics industry.
Leadership Insights on the Launch
Cameron Groome, the CEO & President of Microbix, expressed excitement regarding the QUANTDx™ launch. He noted, "This launch signifies a strategic enhancement of our capabilities to better support assay developers and clinical laboratories. Capitalizing on our in-house expertise in nucleic acid quantification and a robust portfolio of organisms, we are set to deliver dependable and reproducible reference materials that will expedite the processes of assay development and validation."
Market Demand for High-Quality Reference Materials
Phil Casselli, SVP of Sales and Business Development at Microbix, added his thoughts on the initiative, stating, "We are overwhelmed by the positive feedback we've received from potential customers regarding QUANTDx™. There is evident, unmet demand for high-quality and fully quantified reference materials within the diagnostics sector. We anticipate this launch will open numerous opportunities for Microbix to assist assay developers, laboratories, and manufacturers on a global scale. QUANTDx™ is projected to drive revenue growth and widen our international customer base."
About Microbix Biosystems Inc.
Microbix Biosystems Inc. specializes in developing proprietary biological products aimed at improving human health. With a robust team of over 120 skilled professionals, the company is on track to achieve revenues exceeding C$ 2.0 million monthly. Microbix plays a pivotal role in the commercialization of diagnostic assays by providing a broad range of crucial components and devices for the global diagnostics industry. Their offerings include antigens for immunoassays and their laboratory quality assessment products (QAPs™) and reference materials (QUANTDx™), which are essential for clinical laboratory proficiency testing, assay validation, and maintaining quality in clinical diagnostics workflows. It’s noteworthy that Microbix's antigens support approximately 100 diagnostics manufacturers, while their QAPs and QUANTDx materials are utilized by clinical lab accreditation bodies, diagnostic companies, and various clinical laboratories. Currently, Microbix QAPs are available in over 30 countries through a network of international distributors, and the company maintains accreditation from ISO 9001 & 13485, and is registered with the U.S. FDA, Australian TGA, and licensed by Health Canada, ensuring compliance with IVDR regulations.
Contact Information
For further inquiries regarding QUANTDx™, you can reach Microbix at:
Cameron Groome, CEO
Phone: (905) 361-8910
Jim Currie, CFO
Phone: (905) 361-8910
Deborah Honig, Investor Relations
Adelaide Capital Markets
Phone: (647) 203-8793
Email: ir@microbix.com
Frequently Asked Questions
What is QUANTDx™?
QUANTDx™ is a new line of characterized reference materials launched by Microbix, aimed at supporting diagnostic assay development.
How many materials are included in the initial launch of QUANTDx™?
The initial launch includes over 80 reference materials covering six disease panels.
What metrics can be established using QUANTDx™ materials?
Assay developers can establish metrics such as Limit of Detection (LoD), Sensitivity, and Specificity using these materials.
How does QUANTDx™ fit within Microbix’s broader product offerings?
QUANTDx™ complements Microbix’s Quality Assessment Products (QAPs™), enhancing the support for diagnostic development activities.
Who can benefit from using QUANTDx™?
Assay developers, clinical laboratories, and manufacturers can all benefit from the precision and quality of QUANTDx™ reference materials.
