Insight

Jul 31, 2025, 13:56

MRD Testing in Solid Tumors: Clinical Evidence and Coverage Challenges – Market Access 360 Insights

Bridging the Gap: Clinical Evidence and Coverage Readiness for MRD Testing in Solid Tumors

Minimal Residual Disease (MRD) testing has gained significant traction in hematologic malignancies and is now moving into the solid tumor space. However, despite its promise, coverage and reimbursement remain a challenge. A recent evidence assessment by Market Access 360 Insights (MA360i) sheds light on the current status of MRD testing in solid tumors, highlighting gaps in clinical evidence and payer readiness.

“Market Access 360 Insights (MA360i) is transforming diagnostics commercialization and market access by empowering innovative diagnostic labs to get paid for their breakthroughs with AI tools.

Minimal Residual Disease (MRD) testing in solid tumors is rapidly emerging as one of the most promising diagnostic frontiers in precision oncology. While the clinical innovation is accelerating, the path to widespread adoption and payer coverage remains uncertain – primarily due to gaps in aligned evidence and evolving payer expectations.

At MA360i, we recently completed a focused assessment of the clinical evidence and coverage implications for MRD testing in solid tumors, synthesizing published studies, guideline positions, and payer policy signals. This work was driven by a core question we hear across diagnostics stakeholders: What evidence do payers really need to support coverage for breakthrough diagnostics?

What Our Assessment Revealed?

Our analysis – summarized in a 1-page infographic – highlights several key insights:
The evidence base is growing but fragmented. While several MRD technologies have demonstrated potential clinical utility in early-stage and post-treatment settings, most studies are small-scale, observational, or lack payer-relevant endpoints.
Guideline momentum is building, but inconsistently. Some specialty societies are beginning to recognize the role of MRD in surveillance, but few have issued strong, test-specific recommendations that would directly influence payer policy
Payer coverage remains highly selective. Current coverage policies are limited and focused largely on hematologic malignancies. For solid tumors, payers are cautiously watching for clinical trial endpoints tied to treatment changes, outcomes, or cost-offsets.

Why This Matters?

For diagnostic developers and investors, understanding the evidence-to-access pathway is crucial. Breakthrough technologies can underperform commercially – not due to lack of innovation – but due to misalignment with what payers need to see to say “yes.”

Our MRD assessment offers a model for how diagnostic developers can use evidence landscaping to identify gaps early, refine development plans, and proactively shape payer engagement strategies.

Access the infographic here.”

Read more posts on Solid Tumors on OncoDaily.