The GentraceDx National Pilot
500 Patients. All Provinces. A New Standard for Precision Oncology.
A Genome Canada GAPP-funded initiative to clinically validate and integrate continuously updating, multiomic diagnostics across the national oncology frontline.
Establishing the New National Standard for Precision Oncology
The GenTraceDx National Pilot is a 500-patient, multi-site, pan-Canadian clinical initiative designed to demonstrate the clinical and economic superiority of the world’s first living, multiomic diagnostic system.
As a strategic collaboration between Genetrack Biolabs and the Michael Smith Genome Sciences Centre (GSC), and supported by Genome Canada and Genome BC, this deployment embeds GenTraceDx directly into real-world oncology workflows nationwide to establish the evidence base for national adoption and reimbursement.
This is the foundational phase for a new national standard in precision oncology.
Pilot Objectives
Demonstrating Clinical Superiority, Operational Integration, and National Impact
The pilot is designed to validate three core dimensions of the GenTraceDx platform in real-world clinical deployment:
Clinical Superiority
- Actionable Insights: Surfacing off-label (DIN) targets, SAP pathways, and novel findings previously invisible to legacy panels.
- Multiomic Synergy: Quantifying the clinical impact of integrated DNA + RNA insights on treatment selection.
- Continuous Reanalysis: Longitudinal AI re-interrogation surfacing new therapeutic opportunities over time.
- Optimized Clinical Outcomes: Demonstrating improved patient trajectories through precision-driven interventions and reduced toxicity.
Operational Integration
- Workflow Integration: Seamless integration of kits and Agentic AI portals into real-world oncology workflows.
- National Adoption: Standardizing logistics and kit distribution across the clinical frontline.
- System Interoperability: Integration with provincial cancer registries and clinical reporting systems.
- Clinician Engagement: Evaluating the impact of autonomous, real-time clinical alerts on medical decision-making.
Economic & System Impact
- Reimbursement Readiness: Generating the evidence base required for national public and private-payer reimbursement.
- System Efficiency: Improved drug selection efficiency and cost-avoidance from ineffective treatments.
- Data Asset Growth: Building a secure, high-fidelity multiomic dataset to power future clinical insights and therapeutic development.
- Infrastructure Resilience: Establishing a sustainable, national framework for advanced precision oncology.
A Pan-Canadian Multiomic Precision Oncology Study
- Sample Size: 500 patients
- Geographic Coverage: All Provinces and Territories Nationwide
Participants:
- Adult and pediatric oncology patients
- Solid and hematological malignancies
- Patients with rare and complex tumour profiles
- Patients referred by participating cancer centres
Inclusion Criteria:
- Confirmed cancer diagnosis
- Availability of tumour sample (FFPE)
- Consent for WES, RNA, and longitudinal AI reanalysis
- Consent for de-identified research use
Exclusion Criteria:
- Inadequate sample quality
- Incomplete or non-conforming clinical information
NATIONAL PILOT DEPLOYment
A National Clinical Infrastructure for Autonomous Oncology
A seamless, end-to-end clinical workflow—from nationwide logistics to continuously updating therapeutic intelligence.
What the Pilot Measures
Key Metrics That Demonstrate Clinical & System Impact
Primary Endpoints
- Increase in actionable findings compared to legacy panel tests
- Providing therapeutic options for patients where standard methods yield no actionable results
- Number of patients receiving new therapeutic options due to RNA-based insights
- Number of new clinical opportunities surfaced through continuous reanalysis
Secondary Endpoints
- Embedding the living diagnostic system into national oncology workflows as a routine clinical standard
- Success rate of matching patients to global clinical trials via the Agentic Discovery Engine
- Number of Special Access (SAP) and off-label DIN applications successfully informed
- Evaluating clinician satisfaction
- Quantifying system-level cost avoidance and improved drug-selection efficiency
Exploratory Endpoints
- Establishing the foundational infrastructure for a national, living diagnostic system
- Generating a definitive longitudinal multiomic dataset for therapeutic discovery
- Mechanistic insights into pathway activation and molecular resistance signatures
- Neoantigen discovery and identification of novel targets
Participating Sites
National Collaboration
Strategically deploying across the national clinical frontline:
- Provincial cancer agencies
- Major oncology centres
- Community oncology networks
- Rural and remote health partners
- Academic hospitals
- Indigenous health sites (where appropriate)
A formal list will be posted in January 2026.
Ethics, Data Security & Compliance
Clinical-Grade Precision With Full Data Sovereignty
- Ethics approvals obtained through provincial REBs
- CAP/CLIA/DAP-compliant workflows
- ISO/GMP manufacturing standards
- PIPEDA- and PHIPA-compliant privacy frameworks
- Canadian data sovereignty: all data hosted on Canadian servers
- De-identified research dataset generated for future genomics + AI studies
Why This Pilot Matters
Setting the Stage for National Adoption
This pilot is designed to:
- Build clinical evidence required for provincial cancer agency funding
- Support national adoption through AI-driven outcomes
- Create a first-of-its-kind living, multiomic cancer dataset
- Reduce reliance on U.S. diagnostic companies
- Establish a global benchmark for continuously updating cancer testing
- Enable future CDx, PMA, SAP-support, and neoantigen vaccine programs
GenTraceDx is not just a diagnostic. It is new national infrastructure for precision oncology.
Get Involved
Clinicians, Researchers, and Institutions: Join the Pilot
We are onboarding:
- Oncology clinics
- Cancer centres
- Academic hospitals
- Northern and rural health systems
- Research institutes