With a strategic investment from Canada’s Digital Technology Supercluster, a pilot project to bring ctDNA testing into the Canadian health system was launched in July 2020. Known as Project ACTT (Access to Cancer Testing & Treatment), the project demonstrated that the ability to conduct ctDNA testing at a local laboratory broadened access to rural and underserved populations, removing geography as a barrier to informed cancer treatment decisions. Such testing also kept high-risk patients out of hospitals and other healthcare settings during COVID-19.
The project’s primary goals were to:
- Enable sustainable funding by generating ctDNA health technology assessment data
- Provide 2,000 liquid biopsy tests to cancer patients between July 2020 – July 2021
- Improve transferable liquid biopsy technology
Key findings specific to ctDNA testing conducted during Project ACTT, as well as recommendations for replication in other locales, are summarized below.
Real world data
During Project ACTT, Canexia Health’s liquid biopsy assay, Follow It(R), was used for testing for patients with advanced colorectal, lung and breast cancers. Follow It analyzes ctDNA in plasma isolated from peripheral blood, focusing on clinically actionable sensitizing and resistance mutations within a carefully selected set of hotspots.
The version of Follow It deployed during the project targeted 30 genes most relevant for selection of treatment, providing a robust and cost-effective solution for clinical molecular testing with a short turnaround time from sample receipt in Canexia’s lab to clinical report (approximately 7 business days).
Oncologists overwhelmingly responded to the pilot project, with an 80 percent adoption rate among solid tumor oncologists working in more than 100 institutions. The project reached patients in 12 provinces and territories, and exceeded its target of reaching patients in remote and rural areas, with 11 percent of samples received outside of major urban centers.
- The overall success rate of blood sample testing was high: 99.3 percent of samples that arrived at Canexia’s lab were viable for testing.
- Within the project’s three cancer types (breast, lung, colorectal), in ∼50 percent of cases, one or more mutations were identified, reflecting published frequencies of detectable mutations in plasma of these patients.
- The spectrum of detected mutations included both frequently mutated genes in respective cancer types (such as PIK3CA in breast, EGFR in lung and KRAS in colorectal), as well as many other less frequently altered genes.
- Approximately 37 percent of mutation-positive cases received recommendations regarding FDA approved Tier I/II targeted treatments, such as EGFR inhibitors in lung cancer, and panitumumab and cetuximab in colorectal cancer based on KRAS mutation status.
Recommendations for replication
Project ACTT demonstrated that innovation in cancer testing can minimize the collateral damage of COVID-19 on cancer patients. However, this innovation should not be considered a one-off in response to a single crisis, but rather, a long-term solution that can be adopted as standard of care anywhere in the world.
Recommendations to replicate such an initiative within a national health system include recruiting a strong network of ecosystem partners, identifying the data required to make the clinical and health economics case for reimbursement for ctDNA testing, and educating key stakeholders early in the program – especially oncologists and patient advocacy groups.
For additional findings and recommendations, download the paper.