Asia’s First Real World ctDNA-MRD Study

Asia’s First Real-World ctDNA-MRD Study Validates Affordable Breakthrough in Cancer Monitoring.

A significant study came out in March 2025 from JCO Oncology Advances. It explores how K-TRACK™ can monitor how patients respond to treatment and evaluate the risk of cancer returning. The research included 623 patients with solid tumors from six different cancer types, which are lung, colorectal, breast, gastric, liver, and ovarian cancer(1).

Gene Solutions, a biotechnology company dedicated to advancing precision oncology in Asia, is excited to announce the publication of a pioneering real-world study in JCO Oncology Advances, validating circulating tumor DNA (ctDNA) as a strong prognostic biomarker to effectively monitor patients during cancer management.

K-TRACK™ is an important advancement in affordable tumor profiling and personal cancer monitoring using ctDNA technology. This first-of-its-kind study in Asia demonstrates the clinical benefits of K-TRACK™ in detecting cancer at both early and advanced stages. The test can identify remaining cancer cells (known as Minimal Residual Disease, or MRD) after major treatment and can forecast cancer's return months earlier than older methods. It also effectively tracks treatment progress. This innovative approach provides hope to patients in regions where access to advanced diagnostic tools is difficult.

Asia has nearly half of the world's cancer cases, and the number is increasing very fast. Some richer countries in Asia have seen a decrease in cancer deaths, but Southeast Asia still has high death rates due to cancer coming back after treatment (2,3).

Studies have found that ctDNA can predict patient outcomes in different cancers before and after treatment (4). But, ctDNA testing is not widely used. This is mainly because it costs a lot, there are no set testing guidelines, and real-world evidence of its usefulness in clinics is lacking.

K-TRACK™ is a practical and dependable test that checks ctDNA in various solid tumors. It helps find cancer returning early and monitors how treatments are working in real-time. Proven effective in both clinical trials and real-world settings, K-TRACK™ aims to significantly improve cancer care while being available to many people.

Here's how it works:

Affordable Innovation: K-TRACK™ stands out by blending tumor profiling of 155 common mutations with ctDNA monitoring customized to specific tumor changes. It boosts affordability and accuracy for regular clinical use.

Complete Genomic Profiling and Residual Disease Tracking: Initial tumor profiling results help select the best targeted therapies and immunotherapies. Ongoing ctDNA monitoring then provides early warnings of cancer recurrence and checks treatment success.

Designed for Real-World Use: K-TRACK™ delivers reliable results even from tough samples like damaged tissue or blood stored for a long time, well-suited for complex clinical scenarios.

Monitoring ctDNA in real-life situations helps predict if cancer might return, allowing for quick action and better patient outcomes. The K-TRACK™ test is effective for both early and advanced cancer stages in predicting recurrence. After surgery, 84.4% of patients with ctDNA-positive results relapsed, while 96.3% of those with ctDNA-negative results stayed cancer-free. The test can detect a relapse 5.5 to 19.5 months before traditional imaging. Six case studies highlighted ctDNA monitoring's role in predicting treatment response, guiding adjuvant chemotherapy decisions, and identifying new mutations resistant to current treatments. This gives doctors real-time insights to make informed treatment choices.

A Vision for Fair Healthcare:

Dr. Lan N. Tu, the lead researcher at Gene Solutions, explained that many people can't get the latest cancer treatment and tracking because it depends on where they live or their financial situation. This is due to the use of advanced techniques like tumor genomic profiling. K-TRACK™ aims to fix this problem by offering a low-cost and precise method suitable for regular clinical settings.

Gene Solutions is focusing on two main areas:

✔ Clinical Trials and Real-World Studies:

The company conducts in-depth research to demonstrate ctDNA's value across various cancer types and treatment phases. They assess responses to therapies like TKIs and ICIs in lung cancer, apply neoadjuvant therapy in breast cancer, use total neoadjuvant therapy for rectal cancer, and leverage biomarkers to guide immunotherapy in advanced cancers.

✔ Collaborations with Biopharmaceutical Companies:

Gene Solutions seeks partnerships with biopharmaceutical companies to create innovative solutions that speed up drug development across different treatments. As evidence for ctDNA grows, they aim to expand research and partner with others to explore new cancer care applications. This aligns with the FDA's recommendation on using ctDNA as a biomarker to aid drug development for solid tumors, noting that it has several potential regulatory and clinical uses in early-stage settings(5).

Gene Solutions is a leading biotech company in Asia. They specialize in using advanced AI and ctDNA technologies to develop innovative cancer detection solutions. The company collaborates with over 4,500 hospitals and clinics in Southeast Asia. Among their 700 employees, around 250 are skilled biology experts and technicians.

The company is recognized for its significant research contributions, with over 50 articles in scientific journals and more than 50 extensive research studies across different locations. Gene Solutions operates specialized NGS labs, accredited by CAP, located in Singapore and Vietnam. By combining cutting-edge genomics with AI methods, they aim to revolutionize cancer care and enhance patient outcomes.

1. 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
2. Huang, J. et al. (2022) 'Cancer incidence and mortality in Asian countries: a trend analysis,' Cancer Control, 29. DOI:10.1177/10732748221095955.
3. 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.
4. 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.
5. 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. 

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