Discover Pathlight MRD Video Resource Center

Pathlight leverages digital PCR (dPCR) to target patient- and tumor-specific genetic fingerprints, enabling a new standard in sensitivity and specificity.

Pathlight Clinical Insights

In this overview of the updated TRACER study, presented at SABCS 2025, Dr. Mitchell Elliott explains why structural variants (SVs) provide a robust “fingerprint” for cancer monitoring. With a 95% sensitivity for distant recurrence and a 98% negative predictive value, the Pathlight assay delivers high confidence for clinicians. Dr. Elliott details how this ultrasensitive approach tracks tumor fraction changes that precede radiographic progression, offering a powerful tool for both early-stage surveillance and metastatic monitoring.

Provider Perspectives

Dr. Wassim Mchayleh explains the technical advantages of using structural variants (SVs) as biomarkers for tumorigenesis. By combining a NGS approach to define the tumor signature with high-precision digital PCR (dPCR) for monitoring, Pathlight MRD delivers high specificity and sensitivity. Dr. Mchayleh reviews why this SV-based approach minimizes the noise associated with traditional SNV assays and provides a clearer, more confident view of a patient’s molecular residual disease status.

Redefining Recurrence

Watch this session with Dr. Debra Patt and Dr. Doug Flora as they explore the clinical utility of Pathlight MRD, the first platform built on patient-specific structural variants. By focusing on the “whispers” of recurrence before they become the “screams” of clinical relapse, Pathlight empowers clinicians to make more informed, risk-aligned treatment decisions for patients with early-stage breast cancer.

Read the TRACER Study

Proven performance in clinical trials

In a pivotal study, Pathlight demonstrates high sensitivity, specificity, and prognostic utility for EBC patients.

Among 100 patients with Stage I–III EBC, Pathlight delivered 100% sensitivity, 100% specificity and a 13.7 month lead time, creating unparalleled opportunities for detecting recurrence early.

Pathlight also breaks the 1ppm sensitivity barrier, enabling the detection of early, small tumors while they’re still treatable, predicting neoadjuvant response better than RCB or pCR.

%

overall baseline ctDNA detection

(94% ER+, 97% HER2+, 96% TNBC)

%

sensitivity for distant recurrence

(17/17)

%

specificity across all timepoints

(61/61)

months median lead time

(up to 5.3 years)

Proven Performance

• Analytical sensitivity and specificity
• Baseline detection
• Lead time ahead of clinical recurrence

Low Assay Failure Rate ~ 5%

Fast Turnaround

Results expected in:

• 2-3 weeks fingerprint
• 1-3 days subsequent blood tests

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References

Elliott, M SAGA Pathlight AV TRACER. Clin Cancer Res. 2025 (v1.0)