Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF), a Canadian company specializing in life sciences products, and Labquality Oy, a Finnish clinical laboratory quality assessment provider, have introduced an innovative external quality assessment (EQA) program aimed at helping clinical labs better identify head and neck cancers linked to high-risk Human Papilloma Virus (HPV) strains. The new program was launched at the 2025 European Society for Clinical Virology meeting held in Thessaloniki, Greece this week.
Head and neck cancers (HNC), which include tumors in areas like the oral cavity and throat, have a growing association with HPV infections, especially in males. More than 300,000 cases are diagnosed annually in North America and Western Europe, representing about 4% of all cancers. Determining if these cancers are HPV-driven is crucial because patients with HPV-related HNC generally have better treatment outcomes and prognoses, impacting treatment decisions.
Currently, HNC diagnosis involves chemically fixed and paraffin-embedded biopsy samples called FFPE samples. These samples are examined using immunohistochemical (IHC) staining and sometimes PCR-based molecular tests to detect HPV presence. However, before this collaboration, there was no standardized program to assess how accurately clinical laboratories perform these tests.
To address this gap, Microbix developed proprietary FFPE-formatted quality assessment panels called QAPs™ that mimic patient biopsy samples, including both IHC and PCR targets relevant to HNC and HPV testing. Labquality then designed and piloted a new EQA scheme to help labs evaluate their performance using these panels.
The pilot study in early 2025 involved 32 labs equipped with various IHC and PCR testing platforms. The findings revealed significant inconsistencies, particularly in p16 IHC staining results, which are sensitive to subjective interpretation. Labs relying solely on IHC often faced risks of misdiagnosis. The study showed that adding reflex molecular testing through PCR could eliminate this subjectivity and improve diagnostic accuracy, helping to prevent incorrect treatment choices.
Following the pilot’s encouraging results, Labquality is now formally offering the ongoing program under EQA scheme number 6800, titled “HPV-related head and neck cancer control.” Microbix’s FFPE QAPs, designed for this purpose, are stable and safe, replicating the clinical tissue environment closely to enable reliable proficiency testing. The program also allows for additional QAPs on request, broadening its potential to include other virus-associated tissue cancers.
Heidi Berghäll, Labquality’s EQA Solutions Manager for research and development, emphasized the importance of performance validation for both pathology and molecular tests through robust EQA programs. She noted Labquality’s commitment to addressing these clinical needs with this new offering.
Pavel Zhelev, Director of Product Management at Microbix, stressed the company’s dedication to supporting complex diagnostic testing workflows, such as IHC and PCR, for head and neck biopsies. He highlighted Microbix’s ambition to be a trusted partner for proficiency testing and quality assurance providers, clinical labs, and diagnostics manufacturers.
Microbix Biosystems, headquartered in Mississauga, Ontario, employs over 120 people and aims for revenues of $1.45 million (CAD$2 million) or more monthly. The company manufactures and exports a range of biological products including antigens used by about 100 diagnostic makers and laboratory quality assessment products that support assay validation and clinical laboratory accreditation globally. Microbix’s products are sold in over 30 countries through an international distributor network. The company holds ISO 9001 and 13485 certifications, is registered with the U.S. FDA and Australian TGA, licensed by Health Canada, and compliant with EU IVDR regulations.
Labquality Oy, based in Helsinki, Finland, serves over 8,000 EQA customers in more than 60 countries and operates across Finland, Sweden, Poland, and Germany with nearly 200 professionals. Supported by Mérieux Equity Partners, Labquality provides quality assessment services that enable clinical laboratories worldwide to maintain high standards essential for patient care and medical technology advancement.
The introduction of this EQA program represents a significant step forward in standardizing and improving laboratory diagnostics in an area where accurate detection of HPV in head and neck cancers directly influences treatment outcomes. With the combined expertise of Microbix and Labquality, clinical labs now have a practical tool to enhance their testing precision and safeguard patient care decisions in this critical area of oncology.
