Microbix, Labquality launch HPV cancer EQA scheme

Executive Summary

• Microbix Biosystems Inc. has partnered with Labquality to introduce a novel External Quality Assessment (EQA) scheme for clinical laboratories to accurately identify head and neck cancers associated with Human Papilloma Virus (HPV).
• The new EQA scheme, titled "HPV-related head and neck cancer control" (Scheme No. 6800), addresses an unmet need for proficiency testing in diagnosing HPV-driven tumors, which significantly impacts patient prognosis and treatment decisions.
• The program utilizes Microbix’s proprietary FFPE-formatted Quality Assessment Products (QAPs) that mimic clinical specimens, allowing labs to validate both immunohistochemical (IHC) and PCR-based molecular diagnostic methods.

Key Details

• Product/Service: Launch of EQA Scheme No. 6800, "HPV-related head and neck cancer control," designed to assess laboratory competency in diagnosing HPV-associated head and neck cancers.
• Target Condition: Head and neck cancers (HNCs), particularly tumors in the oral cavity and throat driven by high-risk HPV strains. Over 300,000 HNCs are diagnosed annually in North America and Western Europe.
• Technical Solution: Microbix created novel FFPE-formatted QAPs (mimetics of patient samples) containing consistent levels of IHC and PCR targets. These allow labs to test proficiency in both staining protocols and molecular diagnostics.
• Pilot Study Results: A pilot study conducted in 2025 with 32 clinical laboratories identified significant discrepancies in p16 IHC staining protocols due to subjective interpretation. The study demonstrated that reflex testing using molecular methods enhances diagnostic accuracy and prevents inappropriate treatment decisions.
• Launch Event: The scheme is being introduced at the 2025 meeting of the European Society for Clinical Virology (ESCV) in Thessaloniki, Greece, scheduled for September 17 to September 20.
• Company Profile: Microbix Biosystems Inc. is a global provider of biological products for human health, including antigens for immunoassays, QAPs, and reference materials. It is ISO 9001 and 13485 accredited, FDA-registered, and trades on the TSX and OTCQX.

Notable Quotes

• Heidi Berghall, EQA Solutions Manager, Labquality: "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, Microbix: "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."