SAGA Diagnostics Showcases New Pathlight™ MRD Data at SABCS 2025

Studies across all breast-cancer subtypes confirm Pathlight’s ultra-sensitive performance for early recurrence detection and treatment-response monitoring

SAGA Diagnostics, a pioneer in blood-based cancer detection and precision medicine redefining the standard for ultra-sensitive and early molecular residual disease (MRD) detection, will present five posters—three new studies and two trials in progress—at the 2025 San Antonio Breast Cancer Symposium (SABCS), December 9-12, 2025 in San Antonio, TX.

The posters build on the TRACER clinical study findings published in Clinical Cancer Research, which demonstrated 100% sensitivity, 100% specificity, and a 13.7-month lead time to recurrence across all subtypes of stage I–III breast cancer. The data presented at SABCS further validates the best-in-class performance of Pathlight, SAGA’s structural-variant (SV)–based MRD test. This clinical validation data provided the basis for a positive coverage determination for Pathlight under the US Centers for Medicare Services MolDx program. SAGA’s collaborating investigators will also present posters introducing a prospective interventional study designed to evaluate clinical utility using Pathlight.

“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-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.”

Updated TRACER Study Analysis

The retrospective analysis of an expanded set of 121 patients with TNBC, HER2+, or ER+/HER2– early breast cancer showed 100% sensitivity, 100% specificity, and a median 12-month lead time from ctDNA detection to clinical recurrence. Rising ctDNA (“molecular progression”) preceded radiographic progression in all patients, and baseline SVs were reproducibly detected across longitudinal timepoints in both early-stage and metastatic disease.

Studies Advancing Clinical Utility

Pathlight is being used in two studies to evaluate the impact of MRD detection on clinical decision-making:

• Circulating Liquid Biomarkers for Assessment and Identification in Early BREast Cancer (CLAIRE): A multicenter surveillance study using Pathlight every three months for up to five years in intermediate- to high-risk ER+/HER2– early breast cancer, to prospectively characterize the surveillance process and identify candidates for interventional MRD trials.
• CApecitabine for Targeted Eradication of Rising ctDNA Molecular Residual Disease in ER+/HER2- Breast Cancer (CATER): An open-label, Phase II study testing 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 will be used to assess ctDNA clearance at 16 weeks as the primary endpoint.

Additional posters will be presented focusing on TNBC, including a poster spotlight, highlighting Pathlight’s performance in the neoadjuvant setting.

“The studies presented at SABCS 2025 continue to validate what we consistently see with Pathlight—ultra-sensitive ctDNA detection that can meaningfully improve early breast-cancer management,” said Wendy Levin, MD, MS, Chief Clinical Officer of SAGA Diagnostics. “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.”

SAGA Diagnostics 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, and Dr. Elliott’s contributions to advancing ultra-sensitive MRD detection in breast cancer exemplify that standard.

Key SAGA Diagnostics presentations during SABCS 2025:

The full posters will be available on SAGA Diagnostics’ website after they are presented.

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. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20251201531260/en/

“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,” said Wendy Levin.