OBJECTIVES: The clinical promise of circulating tumor DNA (ctDNA) testing is clear: no more tissue biopsies for cancer patients, earlier diagnosis, and precision medicine tailored to the changing genetic profile of patients’ cancer. However, the reality of establishing equitable patient access to ctDNA testing, in particular tests based on next-generation sequencing (NGS), is a multifactorial challenge. This research explores opportunities and key market access challenges for NGS-based ctDNA testing.

METHODS: A targeted literature review was carried out to look at incorporation of NGS-based ctDNA testing into clinical trial design, implementation into clinical practice, and payer acceptance.

RESULTS: NGS-based ctDNA testing has gained importance as a tool for screening, monitoring, and early diagnosis in cancer. Results demonstrated that clinical validation of ctDNA testing would require separate indication-specific trials, which can become more challenging with joint clinical assessment. The use of ctDNA testing in clinical practice is also likely to raise issues around equity considerations, especially in Europe and Canada, where test access varies across regions. Additional requirements for training programs and development of protocols will need to be considered. Payer acceptance will also be influenced by the lack of real-world evidence, as seen in the 2022 National Institute for Health and Care Excellence review of Signatera® for solid tumor cancers, and lack of guidelines. A single biomarker ctDNA test for non-small cell lung cancer has already been acknowledged by Health Technology Assessment agencies as potentially cost-saving; however, NGS-based ctDNA testing is more expensive, so payers will want to see evidence to justify this cost.

CONCLUSIONS: The scientific promise of ctDNA testing is clear; however, considerable challenges remain before payers reimburse NGS-based ctDNA tests required for proactive detection. Ultimately, payers will need to be convinced that ctDNA testing provides economic and therapeutic value to patients and healthcare systems.