FLOQSwab-formatted QAP Supporting MDx Tests for H. pylori
Mississauga, ON (GLOBE NEWSWIRE) - Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that it 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 (“H. pylori”), the bacterial cause of stomach ulcers, at Labquality Days, a lab diagnostics conference taking place in Helsinki, Finland from February 8 to 10, 2024.
H. pylori infection was discovered to be the cause of stomach (gastric) ulcers in the 1980’s, 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, poses 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 (https://www.labquality.com).
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 dessicated 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.”
Purchase enquiries for these and all Microbix QAPs can be e-mailed to firstname.lastname@example.org.
About Microbix Biosystems Inc.
Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 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 & 13485 accredited, U.S. FDA 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 TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of Labquality or its conference, the Poster, the H. pylori QAPs, 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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