SAGA Diagnostics’ Pathlight™ MRD Further Demonstrates Clinical Validity In TNBC Trials Presented at SABCS

New trials highlight Pathlight’s performance in the neoadjuvant triple-negative breast cancer (TNBC) setting

MORRISVILLE, N.C.--(BUSINESS WIRE)--#BreastCancer--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, joined collaborating investigators at the San Antonio Breast Cancer Symposium (SABCS) in San Antonio, TX this week to present data from two trials evaluating neoadjuvant therapy outcomes in triple-negative breast cancer (TNBC).

Both the Neo-N Trial and the Dana Farber Cancer Institute TNBC Multi-Center Registry build on the performance established in SAGA’s sentinel TRACER study, which demonstrated Pathlight’s exceptional accuracy across early-stage breast cancer. The expanded TRACER analysis, also presented at SABCS, further validates the strength of Pathlight’s structural-variant–based design, underscoring its ability to detect ctDNA with outstanding sensitivity and consistency.

Neo-N Phase 2 Trial

Conducted in collaboration with Dr. Sherene Loi at the Peter MacCallum Cancer Center and the Breast Cancer Trials Cooperative Group in Australia, Neo-N assessed the association between ctDNA dynamics and event-free survival in early-stage TNBC patients receiving neoadjuvant carboplatin/paclitaxel and nivolumab. The objective was to determine if ctDNA could be a promising tool for ctDNA-guided escalation/de-escalation strategies to refine neoadjuvant chemo-immunotherapy for early TNBC patients. Baseline ctDNA was detected in 91% of stage I–II patients, enabling near-universal monitoring. Early ctDNA clearance during treatment correlated strongly with higher pathological complete response (pCR) rates and improved event-free survival (EFS); in the on-treatment ctDNA positive group, no pCRs were achieved and three-year EFS was 45%, compared to 90% three-year EFS in the ctDNA negative group.

“Neo-N offers compelling evidence that ctDNA dynamics can help guide real-time treatment decisions for TNBC,” said Dr. Sherene Loi, MBBS, PhD, FRACP, FAHMS, GAICD, Peter MacCallum Cancer Center. “Early ctDNA clearance aligns with better outcomes, underscoring how ultra-sensitive monitoring can support personalized treatment strategies, optimize neoadjuvant chemo-immunotherapy and complement current surgical endpoints.”

Dana Farber Cancer Institute TNBC Multi-Center Registry

In collaboration with Dr. Heather Parsons and the Dana Farber Cancer Institute, this trial examined MRD prevalence and clearance during preoperative systemic therapy and its association with pathological complete response (pCR) in early-stage TNBC. In the adjuvant setting, 100% sensitivity and 99% specificity were observed using Pathlight.

Among 80 patients, Pathlight detected ctDNA in 93.4% at diagnosis, supporting robust on-treatment monitoring. ctDNA clearance showed high negative predictive value for pCR — 78.4% during therapy (85.7% with immunotherapy) and 71.8% preoperatively. In patients with pathologic residual disease, ctDNA detected after surgery persisted despite adjuvant therapy, which all resulted in subsequent disease recurrence.

“This is the first trial to evaluate MRD dynamics within the context of Keynote-522, now standard of care for patients with TNBC,” said Dr. Heather Parsons, MD, MPH, Fred Hutchinson Cancer Center. “The findings reinforce ctDNA as a powerful biomarker for personalized risk assessment and response monitoring in early-stage TNBC. I look forward to the results of the interventional studies assessing how to best use ctDNA to care for our patients.”

Pathlight will also be incorporated in an interventional Phase II trial to evaluate how MRD detection informs clinical decision-making in high-risk ER+/HER2– early breast cancer: the CLAIRE Trial, which applies Pathlight for long-term surveillance to identify candidates for intervention in the CATER-MRD Trial, which will use Pathlight to measure ctDNA clearance in response to metronomic capecitabine.

“These trials further reinforce Pathlight’s ability to deliver the level of sensitivity and specificity clinicians need to make confident, early decisions in breast cancer care,” said Wendy Levin, MD, MS, Chief Clinical Officer of SAGA Diagnostics. “By anchoring detection to truncal structural variants, Pathlight provides a stable and highly reliable signal. The prospective results will provide valuable data on whether ctDNA-guided management could become an integral part of routine clinical practice.”

To view the posters presented at SABCS, please visit SAGA’s website.

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.

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