Mr. Cameron Groome reports

MICROBIX UNVEILS TEST CONTROL FOR GASTRIC ULCER DISEASE PATHOGEN

Microbix Biosystems Inc. is presenting results of a quality assessment product (QAP) for supporting the clinical use and accuracy of molecular (MDx) tests for infection with Helicobacter pylori, the bacterial cause of stomach ulcers, at Labquality Days, a lab diagnostics conference taking place in Helsinki, Finland, from Feb. 8 to 10, 2024.

H. pylori infection was discovered to be the cause of stomach (gastric) ulcers in the 1980s, in what became a Nobel Prize winning health discovery. The bacteria impact about half of the world's population and, due to untreated infections and the emergence of antibiotic-resistant strains, pose serious health risks. It is difficult to culture this pathogen, leading to the use of MDx methods for rapid diagnosis. However, it has been a challenge to ensure accuracy and reliability of MDx testing for H. pylori infection, as existing liquid matrix test-controls have been found unstable and therefore especially unsuited to point-of-care tests.

Labquality Days is an annual international congress focusing on quality in laboratory medicine and medical devices. It is sponsored by Labquality Oy, a well-established Scandinavian clinical-lab proficiency and accreditation authority that is a Microbix customer and collaborator.

At Labquality Days, Microbix will present a poster titled "A New External Quality Assessment Program for Laboratories that Detect H. pylori and Antimicrobial Resistance Markers Using Nucleic Acid Amplification Test Methods."

The poster details the results of a collaboration with Labquality, within which Microbix developed highly stable QAPs for H. pylori and Labquality created a pilot external quality assessment (EQA) program, each to support labs running MDx tests for the pathogen.

Microbix developed its H. pylori QAP to resemble patient specimens, support the whole testing process and contain all possible MDx test targets -- stabilized and desiccated onto a Copan Floqswab to ensure stability at room temperature. The pilot EQA program confirmed the performance of these QAPs within 13 laboratories running seven different assays/platforms. These H. pylori QAPs are now being made available on a research-use-only (RUO) basis from Microbix as part of its Proceedx Floq catalogue of products.

Pavel Zhelev, lead author of the poster and Microbix's director of product management, commented: "Our growing catalogue of whole-genome and room-temperature stable Floqswab-formatted QAPs continue to demonstrate their ability to support quality management on a wide range of molecular assays and instrument platforms -- for validation, verification and training, as external quality assessment samples, for lab QMS support, and as in-kit controls. We're pleased to now add a product to support both lab-based and point-of-care molecular diagnostic tests for infection with H. pylori."

About Microbix Biosystems Inc.

Microbix Biosystems creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting $2.0-million per month. 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) 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 and 13485 accredited, U.S. Food and Drug Administration registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.

Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (Dxtm) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the Toronto Stock Exchange and OTCQX, and headquartered in Mississauga, Ont., Canada.

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