Coverage marks a step in expanding access to ultra-sensitive molecular residual disease detection for breast cancer patients.
SAGA Diagnostics, specializing in blood-based cancer testing, announced that Palmetto GBA’s Molecular Diagnostic Services Program (MolDX) issued a positive Medicare coverage decision for the Pathlight MRD (molecular residual disease) test.
Pathlight is covered for Medicare beneficiaries for recurrence monitoring in the surveillance setting for up to six years in patients with stage II-III breast cancer, including all subtypes: HR+/HER2-, HER2+, and TNBC.
The Medicare local coverage determination follows a review of evidence demonstrating Pathlight’s analytical and clinical validity and affirms the test’s utility in improving standard-of-care management for patients with early-stage breast cancer. The coverage determination enables eligible Medicare beneficiaries to access the test when ordered by a healthcare provider.
Breast cancer is the most common malignancy among women worldwide, and the second leading cause of cancer death in U.S. women.1 In the US, approximately 300,000 women are expected to be diagnosed with breast cancer in 2025.2 Of these, roughly 90% present at early stages (I–III),3 where timely intervention can improve outcomes. Notably, approximately 75% of all breast cancers are estrogen receptor-positive (ER+), making it the most prevalent molecular subtype4. ER+ breast cancer can have a highly variable prognosis—with nearly 40% of patients characterized as high-risk5—which requires these patients to undergo long-term monitoring for relapse post-surgery.
Currently available MRD tests have limited sensitivity in ER+ disease, especially at baseline (ie, at diagnosis), highlighting an unmet need for early-stage patients with breast cancer who could be cured with timely and effective treatment.
Coverage Decision Based on Clinical Trial
The coverage decision by the MolDX program was primarily based on evidence from the cTdna evaluation in eaRly breAst canCER (TRACER) study, published in Clinical Cancer Research in January 2025.6 The TRACER study demonstrated Pathlight’s clinical performance across all subtypes of early-stage breast cancer. The study reported 100% sensitivity and 100% specificity, with a 13.7-month lead time prior to detection of recurrence by standard-of-care clinical methods, including imaging.
The study also demonstrated a baseline detection rate of 96% across all subtypes in stage I-III breast cancer, and notably 94% in ER+ disease, which underscores its clinical advantages over currently available MRD tests.
“This Medicare coverage decision represents a pivotal moment for patients diagnosed with breast cancer—especially those with ER+ early-stage disease, who now have an ultra-sensitive test to monitor early for cancer recurrence,” says Roopom Banerjee, executive chairman of SAGA Diagnostics, in a release. “Expanded access to Pathlight empowers patients and clinicians to make more personalized, informed treatment decisions to improve outcomes.”
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References
- Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–49.
- American Cancer Society. Cancer Facts & Figures 2024. Atlanta, GA: American Cancer Society; 2024. Available at https://www.cancer.org
- Howlader N, Noone AM, Krapcho M, et al, eds. SEER Cancer Statistics Review, 1975–2020. Bethesda, MD: National Cancer Institute; 2023. Accessed May 5, 2025. Available at https://seer.cancer.gov/csr
- Prat A, Cheang MCU, Martín M, et al. Prognostic significance of progesterone receptor–positive tumor cells within immunohistochemically defined luminal A breast cancer. J Clin Oncol. 2013;31(2):203–9.
- Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012;490(7418):61–70.
- Elliott MJ, Howarth K, Main S, et al. Ultrasensitive detection and monitoring of circulating tumor DNA using structural variants in early-stage breast cancer. Clin Cancer Res. 2025;31(8):1520-32.