Penang, Malaysia – At the 14^th Asia-Pacific Breast Cancer Summit (APBCS) 2026, Gene Solutions presented real-world data on K-TRACK, a novel hybrid circulating tumor DNA (ctDNA) testing approach. This integrative method, combining tumor-informed and tumor-agnostic approach, addresses a critical gap in precision oncology: the challenge of obtaining high-quality tissue specimens in diverse clinical settings.

Enhanced Pre-Treatment ctDNA Detection

The K-TRACK hybrid methodology combines personalized mutation tracking with a 500-gene hotspot panel to ensure reliable mutation detection regardless of FFPE tissue quality.

In both high-quality and suboptimal samples, the hybrid approach enhanced pre-treatment ctDNA detection, boosting rates by up to 30.3% in low-quality tissues and improving yield by 6.7% even in optimal samples.

ctDNA Strongly Predicts Early Recurrence

In a cohort of 110 early-stage patients, post‑operative ctDNA status was a strong predictor of relapse. Patients with detectable post‑operative ctDNA were significantly more likely to recur.

• Prognostic Accuracy: The assay demonstrated 80.0% sensitivity and 98.3% specificity in predicting relapse.
• Lead Time: ctDNA positivity identified recurrence with a maximal lead time of up to 11.0 months before clinical or radiological diagnosis.

These findings support the use of post‑operative ctDNA as a powerful marker of molecular residual disease (MRD), enabling earlier intervention for high‑risk patients.

ctDNA Dynamics Correlate with Treatment Response in Metastatic Breast Cancer

Longitudinal ctDNA monitoring in metastatic disease demonstrated robust alignment with treatment response and disease progression.

• Progression-Free Survival (PFS) Advantage: Longitudinal monitoring revealed a stark contrast in clinical outcomes; at 12 months, 80.0% of Molecular Responders (MRs) remained progression-free, compared to only 50.0% of Molecular Non-Responders (MnRs).
• Superior Risk Stratification: K-TRACK assay identified metastatic disease progression with 70.0% sensitivity and 85.7% specificity, revealing that MnRs carry a 6.63-fold higher hazard of progression than responders (HR=6.63).

These results highlight ctDNA as a practical, real‑time indicator of therapeutic efficacy.

Detection of ESR1 Mutations: A Window into Endocrine Resistance

The inclusion of a tumor-agnostic hotspot panel enabled the early detection of ESR1 resistance mutations, found in 12.5% of metastatic ER⁺ patients. Key variants identified included: Y537N (7.1%), Y538G (3.6%), and P535H (1.8%).

The ability to identify emerging ESR1 mutations through serial ctDNA monitoring provides an opportunity for earlier optimization of endocrine therapy.

Conclusion

Across early-stage and metastatic breast cancer populations, the K‑TRACK hybrid ctDNA assay demonstrated strong clinical utility in a real‑world Asian setting by enabling clinicians to:

• Maximize ctDNA and mutation detection, especially in suboptimal FFPE samples
• Accurately predict recurrence and monitor treatment response
• Identify emerging ESR1 resistance mutations for timely therapeutic intervention

These findings underscore the scalability and effectiveness of hybrid ctDNA profiling in modern breast cancer management.