# Pay for residual disease tests only inside a trial or registry

Source: https://onco.cc/ideas/idea-bio2-mrd-coverage-with-evidence/  
OnCo record `idea-bio2-mrd-coverage-with-evidence` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Leftover-cancer blood tests are being sold faster than evidence that acting on them helps. Paying for them only when the result is recorded would generate the missing evidence.

## Summary

MRD testing is spreading through routine care ahead of randomised evidence that intervention on a positive result improves survival. Coverage with evidence development (reimbursement conditional on enrolment in a registry or trial with mandatory outcome submission) turns uncontrolled adoption into a data-generating engine, as it has for some devices and PET indications.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Conditional coverage produces an analysable dataset of over 50,000 tested patients with linked outcomes within three years, and identifies at least one tumour setting where MRD-guided intervention does not help.
- Rationale: The National Oncologic PET Registry showed that conditional coverage can produce practice-changing evidence quickly at low cost. The alternative, unconditional payment, has repeatedly left the field with widespread use and no answer.
- Proposed test: One national payer or insurer pilots conditional coverage for one tumour type, publishing enrolment, completeness of outcome capture and cost per patient after 18 months.
- Maturity: speculative
- Actor: payer

## Sources

- Bottleneck evidence (Dormant cells and minimal residual disease): Tie et al., ctDNA analysis guiding adjuvant therapy in stage II colon cancer (NEJM 2022): https://doi.org/10.1056/NEJMoa2200075

## Connected records

- collections: [ClinicalTrials.gov](https://onco.cc/collections/clinicaltrials-gov/), [SEER (Surveillance, Epidemiology, and End Results)](https://onco.cc/collections/seer/)
- technologies: [MRD / molecular residual disease testing](https://onco.cc/technologies/mrd-testing/)
- terms: [Real-world evidence](https://onco.cc/terms/real-world-evidence/)
- bottlenecks: [Dormant cells and minimal residual disease](https://onco.cc/bottlenecks/b-dormancy-mrd/), [Incentives reward me-too drugs and marginal gains](https://onco.cc/bottlenecks/b-incentive-misalignment/), [Weak real-world evidence and registries](https://onco.cc/bottlenecks/b-real-world-evidence/)
- key papers: [IMvigor011: using a blood test for leftover cancer to decide who gets immunotherapy after bladder surgery](https://onco.cc/key-papers/paper-imvigor011-nejm-2025/)
- roadmaps: [ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment](https://onco.cc/roadmaps/ctdna-tests/), [Diagnostics roadmap: stains → gene panels → blood tests that decide treatment](https://onco.cc/roadmaps/diagnostics-roadmap/)

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