The Future of Pathology: Integrating Molecular EQA for Improved Cancer Care

The Canadian Pathology Quality Assurance (CPQA) helps ensure patients receive the most accurate diagnoses and informed treatment decisions for the best possible health outcomes. CPQA aims to achieve this by continuously working toward accuracy and reliability of testing, including immunohistochemistry (IHC) and next-generation sequencing (NGS).

“IHC is a widely used technique that uses antibodies to identify and locate specific antigens in tissue samples and plays an important role in cancer diagnosis and treatment planning," says Blake Gilks, MD, FRCPC, one of CPQA's founders, consultant pathologist at Vancouver General Hospital, and professor emeritus at the University of British Columbia. "In the early days, we would implement new immunostains without a gold standard for validation, leading to uncertainty about our results."

Originally founded as an academic program at the University of British Columbia and the University of Saskatchewan, the program eventually evolved into the CPQA. Recognizing the growing need for pathologists in Canada and the lack of standardized quality control led the organization to expand beyond academia to support diagnostic medical laboratories on a broader scale. Today, the CPQA helps labs monitor and improve the quality of their testing.

To advance molecular diagnostics, quality assurance, and emerging technologies, the CPQA hosts an annual symposium. This event provides an invaluable opportunity for pathologists, scientists, researchers, and histotechnologists to connect, share insights, and discuss the latest advancements in pathology. It also serves as a platform for mentoring and developing the next generation of pathologists.

At this year's symposium in Victoria, BC, the Molecular Biomarker External Quality Assurance (EQA) program will present its third round of results. Biomarkers play a pivotal role in guiding cancer care, serving as vital indicators of cancer risk and aiding in treatment decisions. This program ensures that biomarker testing meets the highest standards of accuracy and reliability, supporting proficiency testing as an important part of medical laboratory practice.

Brandon Sheffield, MD, FRCP, a pathologist in the Division of Advanced Diagnostics at the William Osler Health System (Osler), and a researcher of the Osler Research Institute for Health Innovation (ORIHI), has been instrumental in developing this initiative, driven by a commitment to improving diagnostics, particularly in cancer treatment. "Brandon, known for his passion and expertise in the field, immediately stepped up," says Jennifer Won, PhD, lead organizer of the CPQA conference. "He is dedicated to advancing diagnostics with this comprehensive, end-to-end solution."

The Molecular EQA program was designed with the evolving landscape of pathology in mind. "We’ve been conducting EQA for IHC for decades—covering biomarkers like breast cancer and MMR, but the field is advancing rapidly,” says Sheffield. “Even the name of our specialty has evolved from anatomic pathology to diagnostic pathology and now molecular pathology. Our latest EQA projects reflect these changes, ensuring we keep pace with advancements in biomarker testing."

Traditional quality assurance programs focus only on analytical accuracy, leaving a gap in ensuring that the results are precise and actionable for patient care. The Molecular EQA program goes beyond just accuracy to also evaluate report clarity, how quickly results are delivered, and the result interpretation.

Sheffield and his team at Osler endeavor to support laboratories to deliver clear, clinically useful reports that directly impact patient care. Sheffield, charge technologist Andrea Beharry, genomic data analyst Kassandra Bisson, and others from the Osler team have worked collaboratively to make the program an essential resource for laboratories that are aiming to improve their molecular biomarker testing processes. By its third round, the Molecular EQA program has also gained strong industry support. 

The program’s methodology is both straightforward and groundbreaking. Using multiple testing modalities—such as IHC, NGS, and other methods—laboratories analyze tissue samples and are given a simulated clinical scenario. Their reports are then reviewed by a multidisciplinary team, including the medical oncologists who assess the appropriateness of treatment plans based on the lab findings. This benchmarking process helps labs meet the high standards required for precision cancer care.

"The end-to-end EQA approach is already demonstrating substantial improvements in turnaround time for consistently participating labs," says Sheffield. "By refining their processes and leveraging the data-driven insights provided, repeat participant labs are achieving faster, more reliable results—ultimately elevating overall laboratory performance. The latest results and training will be presented at the annual CPQA symposium in Victoria this June."

The Molecular EQA program’s comprehensive approach has been widely recognized as a valuable contribution to molecular diagnostics. Sheffield’s leadership and the dedication of his team have positioned the Molecular EQA program as a gold standard in the industry, helping clinical laboratories provide more accurate and actionable test results for cancer patients across Canada.