Circulating Tumor DNA Assays in Clinical Cancer Research

Area of Science:

• Oncology
• Molecular Biology
• Biomarker Discovery

Background:

• Circulating free DNA (cfDNA) analysis in cancer research began in 1994.
• Circulating tumor DNA (ctDNA), derived from tumor cells, constitutes up to 1% of cfDNA in cancer patients.
• ctDNA is a dynamic biomarker obtainable through minimally invasive methods, valuable for early detection, diagnosis, and treatment monitoring.

Purpose of the Study:

• To discuss the current state and future directions of circulating tumor DNA (ctDNA) assays in clinical cancer research.
• To identify challenges and opportunities for translating ctDNA assays into clinical practice.
• To foster collaboration between industry, academia, and regulatory agencies.

Main Methods:

• A workshop was convened by the National Cancer Institute's Division of Cancer Treatment and Diagnosis on September 29-30, 2016.
• Discussions focused on background, clinical utility, assay technology, validation, and industry perspectives on ctDNA assays.
• Expert input was gathered from industry, academia, and government research and regulatory agencies.

Main Results:

• The workshop highlighted the significant potential of ctDNA assays as biomarkers.
• Key challenges in assay technology, clinical validation, and analytical validation were identified.
• Industry perspectives emphasized the need for standardization and regulatory clarity.

Conclusions:

• Despite challenges, ctDNA assays hold great promise for advancing cancer care.
• Continued research and development are crucial for the clinical translation of ctDNA assays.
• Collaboration is essential to overcome hurdles and realize the full potential of ctDNA in oncology.