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Asia’s First Real-World ctDNA-MRD Study Strengthens Evidence for Cost-Effective Cancer Monitoring
Apr 20, 2025A landmark study recently published in March 2025 by JCO Oncology Advances, demonstrates the potential of
Fig 1. ctDNA analysis workflow. For patients at early stage I-III, paired tumor FFPE and WBC DNA samples were sequenced to identify tumor-specic mutations in 155 cancer-associated genes. Top personalized mutations with the highest ranking scores were used to detect ctDNA in plasma samples by mPCR and ultradeep sequencing. For patients at metastatic stage IV, besides personalized mutations, an additional panel of approximately 500 hotspot mutations specific to each cancer type was added to the analysis.
Real-world monitoring of ctDNA has proven effective in predicting early cancer recurrence, allowing for timely interventions and improved patient outcomes. In both early and advanced-stage cancer patients, K-TRACKTM has demonstrated high accuracy in predicting recurrence. Following surgery, 84.4% [CA1] of patients with ctDNA-positive results eventually relapsed, while an impressive 96.3% [CA2] of those with ctDNA-negative results remained cancer-free. Moreover, the test could detect relapse up to 5.5-19.5 months earlier than clinical diagnosis by imaging methods. Simultaneously, the six case studies presented illustrated the clinical utility of ctDNA monitoring in predicting treatment response, informing adjuvant chemotherapy decisions, and identifying new resistant mutations to current targeted treatment. Thus, empowering clinicians with real-time, actionable insights to inform treatment decisions.
Fig 2. Prognostic value of ctDNA in early-stage cancer. (A-D) Kaplan-Meier analysis of Disease-free survival (DFS) for patients stratified by postoperative ctDNA status. (E) For patients suspected of recurrence, ctDNA results showed concordance of 87.0% with later diagnosis. (F) No correlation between Variant allele frequency (VAF) of ctDNA and time to recurrence was observed in both suspected and routine surveillance cases.
A Vision for Equitable Care
“Access to cutting-edge, personalized cancer treatment and monitoring-based on tumor genomic profiling- too often depends on where you live or what you can afford,” said Dr. Lan N. Tu, Principal Investigator at Gene Solutions. “Our mission with K-TRACKTM is to close that gap by providing an affordable and precise real-time solution for routine clinical use.”
Gene Solutions is actively investing in two key areas:
1. On-going Clinical Trials and Real-World Studies:
The company is conducting comprehensive research to validate the role of ctDNA across various cancer types and treatment stages. This includes evaluating responses to TKIs and immune checkpoint inhibitors (ICIs) in lung cancer, neoadjuvant therapy in breast cancer, total neoadjuvant therapy in rectal cancer, and the use of biomarkers to inform immunotherapy treatment decisions in advanced cancers.
2. Biopharma Collaborations:
Gene Solutions is actively pursuing partnerships with biopharmaceutical companies to provide innovative solutions aimed at accelerating drug development across a range of therapeutic modalities. As the scientific evidence supporting ctDNA continues to grow, Gene Solutions is committed to expanding its research and fostering collaborations with current and new partners to explore new applications in cancer care. The company’s direction aligns with the FDA’s recommendation on ctDNA use as a biomarker in the development of curative-intent therapies for solid tumors which states: “ctDNA as a biomarker has a number of potential regulatory and clinical uses in the early-stage setting that may assist and expedite drug development.” (5)
About Gene Solutions
Gene Solutions, a multinational biotech company in Asia, is leading the way in leveraging advanced AI and ctDNA technologies for innovative cancer detection solutions. The company partners with over 4,500 hospitals and clinics across Southeast Asia and employs a dedicated team of approximately 250 biology experts and technicians out of a total of 700 employees.
With more than 50 peer-reviewed publications and over 50 multi-center studies conducted across the region, Gene Solutions is recognized for its proprietary research and CAP-accredited next-generation sequencing (NGS) laboratories in Singapore and Vietnam. By integrating multi-dimensional genomics with AI-driven methodologies, the company is committed to transforming cancer care and improving patient outcomes.
- Hoang, V.-A.N. et al. (2025) ‘Real-World utilization and performance of circulating tumor DNA monitoring to predict recurrence in solid tumors,’ JCO Oncology Advances, Volume 2. DOI: 10.1200/OA-24-00084
- Huang, J. et al. (2022) ‘Cancer incidence and mortality in Asian countries: a trend analysis,’ Cancer Control, 29. DOI:10.1177/10732748221095955.
- Sharma, R. et al. (2024) ‘Temporal patterns of cancer burden in Asia, 1990-2019: a systematic examination for the Global Burden of Disease 2019 study,’ The Lancet Regional Health – Southeast Asia, 21, p. 100333. DOI:10.1016/j.lansea.2023.100333.
- Kobayashi, S. et al. (2025) ‘Japan society of clinical oncology position paper on appropriate clinical use of molecular residual disease (MRD) testing,’ International Journal of Clinical Oncology [Preprint]. DOI:10.1007/s10147-024-02683-0.
- Use of Circulating Tumor DNA for Curative-Intent Solid Tumor Drug Development. (2024). In Guidance for Industry [Clinical/Medical]. FDA Guidances, Content current as of: 01/17/2025.
