(MENAFN- GlobeNewsWire - Nasdaq) Supporting Clinical Labs in Accurately Identifying HPV-associated Head and Neck CancersMISSISSAUGA, Ontario and HELSINKI, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. ( TSX: MBX, OTCQX: MBXBF, Microbix® ), a life sciences innovator, manufacturer, and exporter, and Labquality Oy ( Labquality ), announce a novel external quality assessment (“ EQA ”) program to help ensure clinical laboratories accurately identify head and neck cancers associated with cancer-causing strains of Human Papilloma Virus (“ HPV ”). Labquality is introducing this novel EQA scheme at the 2025 meeting of the European Society for Clinical Virology (“ ESCV ”) in Thessaloniki, Greece 17-20 September.
Head and neck cancers (“ HNCs ”), particularly tumours in the oral cavity and throat, are often driven by chronic infection with high-risk types of HPV. It is important to determine whether HNCs are driven by HPV infections, as patients with such tumours have much better prognoses – which impacts their recommended course of treatment. Over 300,000 HNCs are diagnosed in North America and Western Europe each year, accounting for approximately 4% of all cancers and increasingly common in males.
HNC is diagnosed from biopsied tissue chemically fixed with formalin and then embedded in paraffin (“ FFPE ” samples). FFPE samples are then stained for immunohistochemical (“ IHC ”) markers and sometimes also tested for HPV using PCR-based molecular diagnostic methods. Until now, no program existed to check the proficiency of clinical labs in such work. To fulfill this unmet need, Microbix created novel FFPE-formatted“ QAPsTM ” mimetics of HNC patient samples – containing both IHC & PCR targets. In turn, Labquality designed, piloted, and is now launching a new EQA scheme to help labs assess and ensure their competency.
The pilot EQA study was conducted earlier in 2025 involving 32 clinical laboratories using multiple IHC and PCR platforms. It identified significant discrepancies and unresolved risks in p16 IHC staining protocols, primarily due to the subjective nature of results interpretation. It also demonstrated that further (reflex) testing using molecular methods can enhance diagnostic accuracy by eliminating subjectivity-potentially preventing inappropriate treatment decisions. In consequence, Labquality is launching an ongoing program to support clinical labs, as EQA scheme number 6800 titled“HPV-related head and neck cancer control.” More information is available at .
Microbix QAPs are designed to fully emulate clinical specimens from patients while being safe and stable. For this EQA program, Microbix created QAPs formatted as FFPE slides and scrolls that contain a consistent and stable level of IHC and PCR targets relating to HNC and HPV. Additional FFPE-formatted QAPs can be made available upon request to support other tissue-sample tests, including for virus-associated cancers.
Heidi Berghäll, EQA Solutions Manager, R&D of Labquality, commented,“It is important that both pathology and molecular tests are validated via a proper EQA scheme to monitor ongoing performance. Labquality is proud to be launching another new program for addressing these important clinical needs.”
Pavel Zhelev, Director of Product Management at Microbix, also commented,“We continue to enjoy working alongside Labquality to support complex diagnostic tests, such as IHC and PCR testing of head and neck tissue biopsies. Our objective is to be the leading partner for PT/EQA providers, test-makers, and clinical labs to help ensure that their testing attains and sustains the best possible levels of accuracy and quality assurance.”
Enquiries about Microbix QAPs can be e-mailed to ... .
Enquiries about Labquality, or the HNC EQA Scheme can be emailed to ...
About Microbix Biosystems Inc.
Microbix creates proprietary biological products for human health, with over 120 skilled employees and revenues targeting C$ 2.0 million or more per month. It makes and exports a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPsTM) and reference materials (QUANTDxTM) 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.
About Labquality Oy and EQAS
Based in Helsinki, Finland, Labquality is a life sciences company that provides clinical laboratories and point-of-care testing sites with External Quality Assessment Services (EQAS) to evaluate their proficiency and attain necessary accreditations. We advance healthcare, pharmaceutical and medical technology development with a future-focused approach, aligned with client needs. Driven by our commitment to care, we contribute quality to the industry and pave the way for safer, more effective patient care worldwide. Currently, we serve over 8,000 EQA customers in over 60 countries around the world. Our team comprises nearly 200 skilled professionals in Finland, Sweden, Poland, & Germany. Supported by Mérieux Equity Partners, Labquality empowers clients with excellence-driven solutions to achieve the highest standards of care.
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 Labquality and EQAS, HNC and testing, the EQA program, the QAPs, or their relevance, Microbix's 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 to 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, any number 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 or for recent Microbix news and filings.
For further information, please contact Microbix at:
Copyright © 2025 Microbix Biosystems Inc.
Microbix®, DxTM®, Kinlytic®, QAPsTM, and QUANTDxTM are trademarks of Microbix Biosystems Inc.
Other companies' names may be protected by their own respective trademarks
Comments
No comment