SAGA Diagnostics® Announces Medicare Coverage for Pathlight™ MRD Test in Breast Cancer Across All Subtypes

July 30, 2025 at 10:51 AM EDT

Coverage marks a pivotal step in expanding access to ultra-sensitive MRD detection for breast cancer patients
U.S. Medicare coverage decision reflects published, peer-reviewed clinical data demonstrating 100% sensitivity, 100% specificity, and a 13.7-month lead time versus standard-of-care clinical detection of recurrence across all subtypes and early stages of breast cancer

SAGA Diagnostics, a pioneer in blood-based cancer testing redefining the standard for ultra-sensitive molecular residual disease (MRD) detection, today announced that Palmetto GBA’s Molecular Diagnostic Services Program (MolDX) issued a positive coverage decision for the Pathlight MRD 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 rigorous 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. women¹. In the U.S. alone, approximately 300,000 women are expected to be diagnosed with breast cancer in 2025². Of these, roughly 90% present at early stages (I–III)^3,where timely intervention can improve outcomes. Notably, ~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 (i.e., at diagnosis), highlighting a critical unmet need for early-stage patients with breast cancer who could be cured with timely and effective treatment.

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 Research⁶ in January 2025. The TRACER study demonstrated Pathlight’s excellent 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,” said Roopom Banerjee, Executive Chairman of SAGA Diagnostics. “Expanded access to Pathlight empowers patients and clinicians to make more personalized, informed treatment decisions to improve outcomes.”

References

1. 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):209–249. doi:10.3322/caac.21660

2. American Cancer Society. Cancer Facts & Figures 2024. Atlanta, GA: American Cancer Society; 2024. Available from: https://www.cancer.org

3. 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. https://seer.cancer.gov/csr

4. 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):203–209. doi:10.1200/JCO.2012.43.4134

5. Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012;490(7418):61–70. doi:10.1038/nature11412

6. 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):1520-1532. doi:10.1158/1078-0432.CCR-24-3472

About Pathlight™

Pathlight™ is a novel, personalized, tumor-informed multi-cancer molecular residual disease (MRD) platform developed by SAGA Diagnostics. It delivers industry-leading sensitivity and specificity for detecting cancer recurrence and monitoring treatment response by analyzing circulating tumor DNA (ctDNA).

Pathlight uses a proprietary combination of whole genome sequencing and digital PCR to identify and track large-scale genomic changes known as structural variants (SVs) – stable, truncal biomarkers that provide a clearer, earlier indication of disease recurrence. By optimizing for SVs, Pathlight enables ultra-sensitive detection of recurrence and precise monitoring of treatment response in early-stage and metastatic disease.

This advanced approach empowers oncologists to make timely, confident decisions—helping patients avoid unnecessary treatments or receive interventions sooner when needed. Pathlight supports accurate, longitudinal assessments of disease status, enhancing care across the entire patient journey.

Pathlight is covered by Medicare for early-stage breast cancer across all subtypes and is actively used in clinical studies by leading clinical institutions, national cancer centers and major pharmaceutical companies. For more information, visit www.pathlightMRD.com.

About SAGA Diagnostics

SAGA Diagnostics® is redefining the early detection of molecular residual disease (MRD), empowering treatment decisions with greater insight and confidence. Pathlight™, the company’s flagship product, is an ultra-sensitive, blood-based, multi-cancer MRD test that is now available for commercial use in the U.S and reimbursed for patients with early stage breast cancer. SAGA is partnering with pharmaceutical and biotechnology companies, as well as commercial entities, to support early through late-stage cancer development programs across a range of cancer types. SAGA’s headquarters and CLIA-certified laboratory are located in the heart of the life science ecosystem in Research Triangle Park, North Carolina. SAGA Diagnostics combines world-class genomic expertise with a leadership team deeply experienced in MRD, all aligned in the mission to intercept cancer at its earliest stages when it is most treatable. For more information, visit www.sagadiagnostics.com.