47The Impact of a Funded, National, Molecular Testing Program for the Canadian Biliary Tract Cancer Population.
Leonard Angka, Christine Lafontaine, Monica Chacon, Cindy Miskolczi, Kevin James, Shamini Selvarajah, Faisal Khan, Harriet Feilotter, Rebecca C AuerAbstract
Background
Molecular testing to identify tumour biomarkers is recommended by all major treatment guidelines for biliary tract cancer (BTC) and is ideally performed early after diagnosis. Most second-line treatment options for BTC are only available through clinical trials where molecular testing is required for eligibility. Despite these recommendations, many Canadians cannot access molecular testing due to barriers including financial burdens, inadequate testing, and geographic inequities. Here, we present the impact of a funded, national, molecular testing program implemented by the Canadian Cholangiocarcinoma Collaborative (C3).
Methods
The C3 molecular testing program was active from July 1, 2024 to December 31, 2025, in partnership with the University Health Network Genome Diagnostics Laboratory (UHN-GDL) for Ontario patients, and OncoHelix for patients in all other Canadian provinces (excluding Quebec due to existing provincial funding). Patients were eligible if they had locally advanced or metastatic biliary tract cancer, had not previously undergone molecular testing, and were enrolled in the C3 Registry. Both patients and their treating physicians received a clinically certified molecular report detailing any clinically actionable mutations and therapeutic targets.
Results
As of December 31, 2025, >275 patients from eight provinces (ON, BC, AB, SK, MB, NS, NL, NB) received molecular testing from the C3 program and >120 physicians were engaged throughout the process. Genetic alterations were reported in close to 50% of the cases, of which 28% were Tier I (including FGFR2 fusions, IDH1 mutations, KRAS G12C) and 22% Tier 11/111 (including BRAF V600E, BRCA1/2, HER2, KRAS G12D mutations and MDM2 amplifications). Thirteen cases were presented at the C3 National Multidisciplinary Rounds.
Conclusions
In the absence of molecular testing, treatment options for advanced BTC are largely limited. Real-world evidence from the C3 molecular testing program will be analyzed to support efforts toward standardizing and publicly funding molecular testing tor BTC in Canada.