Supporting Informed Decisions on Biomarker Testing in Cancer Care — Consultation Now Open

Current consultation status: Open  
Consultation period: August 8 to September 30, 2025

The Promise of Precision Medicine

Precision medicine capitalizes on our growing knowledge of the human genome and how genetics, lifestyle, and environmental factors influence health. New and emerging precision medicine technologies are experiencing rapid growth within cancer care, enabling the development of more targeted and tailored treatment options for patients. These technologies have the potential to help provide the right treatment, to the right individual, at the right time.

Biomarker Testing Is a Key Component of Precision Medicine

Molecular biomarker testing is a cornerstone of precision medicine. This type of testing characterizes an individual’s genes, proteins, or other molecules to provide important information about a person’s cancer that can inform their eligibility and suitability for different targeted and precision-based therapies.  

Characterizing biomarkers brings the opportunity to support more accurate and timely diagnosis, improve patient outcomes, and reduce adverse effects. Integrating biomarker testing also has the potential to support health systems by bringing efficiencies in care delivery and providing opportunities to reduce overall health care costs.  

The rapid growth of biomarker testing technologies raises important questions for health care decision-makers across Canada about their funding, adoption, and implementation into routine care.

Improving Access to Precision Medicine

At Canada’s Drug Agency, our work aims to support the coordination and alignment of decision-making for biomarker testing to inform treatment selection. During the past year, we launched key initiatives to help address inconsistencies and challenges in the assessment and implementation of precision medicine approaches across Canada.  

Biomarker Assessment Advisory Panel and Assessment Framework  

We established a time-limited Cancer Biomarker Assessment Framework Advisory Panel that is developing a consensus-based framework for assessing genetic and genomic biomarkers. This framework is intended to help inform adoption or funding decisions in cancer care across jurisdictions.  

Our panel consists of leading experts from across Canada who bring diverse experiences, perspectives, and roles in health systems, across sex and gender, race, culture, and geographic regions.  

To inform panel discussions, we conducted an environmental scan to identify the existing frameworks, processes, and guiding principles currently used to inform adoption and implementation decisions across jurisdictions.  

To learn more about our approach to this project and progress to date, watch the recording of our recent informational webinar.  

Consultation on Draft Assessment Framework for Biomarkers Used in Cancer Care

The advisory panel has now developed a draft assessment framework that is intended to inform adoption or funding decisions on molecular, genetic, and genomic biomarker testing in cancer care.

We are inviting feedback on the draft Assessment Framework for Biomarkers Used in Cancer Care. The feedback period is open until September 30, 2025.

Cancer Genetics Community of Practice

The pan-Canadian Cancer Genetics Community of Practice is a collaborative activity between Canada’s Drug Agency, the Canadian Association of Provincial Cancer Agencies, and the Canadian Partnership Against Cancer. The group facilitates knowledge sharing and collaborative strategic activities among individuals and organizations involved in molecular genetics research, assessment, and implementation.  

This action-oriented and solutions-focused community of practice seeks to create a collaborative network for professionals working in cancer genetics across the cancer control system to advance understanding, share best practices, discuss emerging trends, and foster innovation in the field of cancer genetics.  

The group’s first task has been to support and validate the development of the Canada’s Drug Agency–led consensus-based assessment framework for cancer biomarkers, including an implementation plan. A work plan for the coming year is currently being developed, supported by a newly formed steering committee to guide the community of practice.

Improving Our Assessments of Drugs With Companion Diagnostic Tests  

Improvements have been made to how we assess drugs that include a companion diagnostic test when they are part of a drug reimbursement review.

As part of this structured approach, we established a dedicated testing procedures assessment team to conduct reviews of companion diagnostics and produce a Testing Procedure Assessment report for drugs or drug regimens that impact testing resources. This process helps facilitate a consistent understanding of testing requirements to support the equitable and efficient uptake of new targeted therapies, with a focus on implementation. The report covers considerations related to patients and caregivers, health systems, clinical aspects, and costs.