Medicare has expanded coverage for a ctDNA test, a personalized molecular residual disease (MRD) test, to include patients with stage I-III non-small cell lung cancer (NSCLC) in the surveillance setting. This means that both resectable and unresectable NSCLC patients can now access ctDNA testing under Medicare for ongoing monitoring after diagnosis or treatment. This coverage builds on existing Medicare approval for using ctDNA to monitor immunotherapy, a common treatment for NSCLC in both early and advanced stages.
Why This Matters for Lung Cancer Patients
- Earlier Detection of Recurrence: ctDNA uses a blood sample to detect circulating tumor DNA, allowing it to identify cancer recurrence up to a year before it would appear on imaging scans (median lead time: 5 months). This can give doctors and patients a crucial head start in managing the disease.
- High Accuracy: In three independent peer-reviewed studies, ctDNA with Signatera’s test demonstrated a sensitivity of 93–100% and a specificity of 96–100% for detecting extracranial recurrence in NSCLC patients.
- Addresses Gaps in Current Surveillance: Traditional surveillance tools like CT scans can be difficult to interpret and may miss early signs of recurrence. ctDNA offers a more sensitive and specific option to support early intervention, potentially improving outcomes.
Lung Cancer Impact
Lung cancer remains the leading cause of cancer death in the U.S., accounting for about 1 in 5 cancer deaths. In 2025, an estimated 226,650 new cases and 124,730 deaths are expected, with the average age at diagnosis being 70. Despite recent treatment advances, the five-year survival rate for NSCLC remains low at 28%.
Broader Access and Applications
With this new coverage, more lung cancer patients—especially those on Medicare—can benefit from advanced, personalized monitoring. ctDNA is also Medicare-covered for monitoring in colorectal, muscle-invasive bladder, breast, and ovarian cancers, as well as for pan-cancer immunotherapy response monitoring.
What This Means for You
If you have stage I-III NSCLC and are eligible for Medicare, you may now have access to ctDNA for ongoing surveillance. Talk to your oncologist about whether this test could help in your treatment and follow-up plan.
More Reading
Learn how ctDNA Testing Can Help Inform Management of Lung Cancer
Newly Diagnosed With Lung Cancer? What Every Patient Should Know
The Importance of Molecular Testing
Precision Medicines & Immunotherapy
Must Read Tips for Beating Lung Cancer
Join the conversation on Cancer Connect.
References
- Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446-451.
- Lebow ES, Shaverdian N, Eichholz JE, et al. ctDNA-based detection of molecular residual disease in stage I-III non-small cell lung cancer patients treated with definitive radiotherapy.Front Oncol. 2023;13:1253629.
- Martin TK, Dinerman A, Sudhaman S, et al. Early real-world experience monitoring circulating tumor DNA in resected early-stage non-small cell lung cancer.J Thorac Cardiovasc Surg. 2024:S0022-5223(24)00075-8.
- https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=38779&ver=4er=4
