Mr. Cameron Groome reports

MICROBIX CLIENT LABQUALITY INTRODUCES NOVEL EQA SCHEME AT ESCV

Microbix Biosystems Inc. has introduced 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, Sept. 17 to Sept. 20.

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 per cent 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 QAPs mimetics of HNC patient samples -- containing both IHC and 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 a continuing program to support clinical labs, as EQA scheme number 6800 titled "HPV-related head and neck cancer control."

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 Berghall, EQA solutions manager, research and development, 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."

About Microbix Biosystems Inc.

Microbix creates proprietary biological products for human health, with over 120 skilled employees and revenues targeting $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 (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, United States Food and Drug Administration-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 (for example, its DxTM for patient-sample collection). Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ont., Canada.

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