SAGA Diagnostics Presents Breakthrough MRD Data at SABCS 2025, Demonstrating 100% Sensitivity in Breast Cancer Detection
核心洞察
SAGA Diagnostics (搜索) will present five posters at SABCS 2025 showcasing Pathlight (搜索)'s ultra-sensitive molecular residual disease detection capabilities across all breast cancer subtypes.
Updated TRACER study analysis of 121 patients demonstrated 100% sensitivity and specificity with a median 12-month lead time from ctDNA (搜索) detection to clinical recurrence.
Two prospective interventional studies, CLAIRE and CATER, are now enrolling to evaluate whether ctDNA (搜索)-based surveillance can improve clinical outcomes in early-stage breast cancer.
SAGA Diagnostics (搜索) will present five posters at the 2025 San Antonio Breast Cancer Symposium (SABCS) from December 9-12, showcasing new data that validates the ultra-sensitive performance of Pathlight (搜索), the company's structural-variant-based molecular residual disease (MRD) test. The presentations build on previously published TRACER clinical study findings that demonstrated 100% sensitivity, 100% specificity, and a 13.7-month lead time to recurrence across all subtypes of stage I–III breast cancer.
Enhanced TRACER Study Results
The updated retrospective analysis examined an expanded cohort of 121 patients with triple-negative breast cancer (TNBC), HER2 (搜索)+, or ER (搜索)+/HER2– early breast cancer. The study maintained its perfect performance metrics, showing 100% sensitivity and 100% specificity, with a median 12-month lead time from circulating tumor DNA (ctDNA (搜索)) detection to clinical recurrence. Notably, rising ctDNA levels, termed "molecular progression," preceded radiographic progression in all patients studied.
The analysis also demonstrated that baseline structural variants were reproducibly detected across longitudinal timepoints in both early-stage and metastatic disease, reinforcing the reliability of the Pathlight (搜索) platform's approach.
Advancing Clinical Utility Through Prospective Studies
SAGA Diagnostics (搜索) is moving beyond analytical validation into clinical utility assessment through two ongoing prospective studies:
CLAIRE Study
The Circulating Liquid Biomarkers for Assessment and Identification in Early BREast Cancer (CLAIRE) study represents a multicenter surveillance initiative. The study employs Pathlight (搜索) testing every three months for up to five years in intermediate- to high-risk ER (搜索)+/HER2 (搜索)– early breast cancer patients. The primary objective is to prospectively characterize the surveillance process and identify candidates for interventional MRD trials.
CATER Study
The CApecitabine for Targeted Eradication of Rising ctDNA (搜索) Molecular Residual Disease in ER (搜索)+/HER2 (搜索)- Breast Cancer (CATER) study is an open-label, Phase II investigation. The trial tests whether secondary adjuvant metronomic capecitabine can eradicate ctDNA in patients previously diagnosed with high-risk ER+/HER2– early breast cancer who have detectable MRD despite standard curative intent therapies. Pathlight (搜索) will assess ctDNA clearance at 16 weeks as the primary endpoint.
"Building on the very compelling TRACER data, we are advancing into prospective interventional trials to address the critical question of clinical utility," said Dr. David Cescon, Medical Oncologist and Clinician Scientist at Princess Margaret Cancer Centre, University of Toronto. "Our CLAIRE and CATER studies are now enrolling participants to evaluate whether ctDNA (搜索)-based surveillance and intervention can improve outcomes in early-stage breast cancer. This is an important step toward integrating MRD-guided strategies into standard clinical care."
Clinical Validation Supports Coverage Decision
The clinical validation data from these studies provided the foundation for a positive coverage determination for Pathlight (搜索) under the US Centers for Medicare Services (搜索) MolDx program, marking a significant milestone for patient access to this diagnostic technology.
"The studies presented at SABCS 2025 continue to validate what we consistently see with Pathlight (搜索)—ultra-sensitive ctDNA (搜索) detection that can meaningfully improve early breast-cancer management," said Wendy Levin, MD, MS, Chief Clinical Officer of SAGA Diagnostics (搜索). "By leveraging truncal SVs, Pathlight provides a dependable signal clinicians can trust. The new prospective studies take us beyond analytical performance into demonstrating true clinical utility."
Recognition and Future Directions
The company also celebrates the recognition of Dr. Mitchell J. Elliott, first author of the TRACER study, who has been selected to receive the prestigious Margaret Foti Foundation Scholar-in-Training Award at SABCS. This award honors outstanding young scientists conducting high-quality cancer research.
Additional presentations will focus on TNBC, including a poster spotlight highlighting Pathlight (搜索)'s performance in the neoadjuvant setting. The comprehensive data set reinforces the platform's potential to transform early breast cancer management through ultra-sensitive MRD detection across all major breast cancer subtypes.
Pathlight (搜索) is currently available for commercial use in the United States for patients with early-stage breast cancer, representing SAGA Diagnostics (搜索)' flagship blood-based, multi-cancer MRD test designed to intercept cancer at its earliest and most treatable stages.