Navigating the Regulatory Path for ctDNA in Precision Oncology
Regulatory Perspectives from Cori Regan, PhD , Fortrea
Cori Ragan is a Director and Senior Principal Advisor in Regulatory and Quality for Medical Device and Diagnostics, bringing over 15 years of experience navigating global regulatory frameworks. With a strong foundation in both software and electrical engineering, Cori bridges technical innovation and regulatory strategy across a wide range of medical device classifications in the US, Canada, EU, and UK.
Her work spans diagnostics, including IVDs, companion diagnostics, and imaging technologies, alongside advanced digital health solutions such as Software as a Medical Device (SaMD), AI/ML-based applications, and clinical decision support systems. Cori is known for translating complex regulatory requirements into clear, actionable pathways—supporting the development and advancement of innovative healthcare technologies.
Why Regulation Matters in the ctDNA Era
As circulating tumor DNA (ctDNA) becomes more embedded in oncology research and clinical decision-making, regulatory considerations are increasingly central. In the regulatory focused segment of Fortrea’s Precision Oncology in Practice webinar, Cori Regan, PhD (CR) outlines how evolving regulatory frameworks are shaping the development and use of ctDNA assays in clinical trials highlighting the need for innovation to evolve alongside regulatory clarity and operational rigor.
The Evolving Regulatory Landscape for In Vitro Diagnostics
The regulatory environment governing in vitro diagnostics is undergoing significant change, particularly in Europe. The transition from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) marks a fundamental shift in expectations.
Under IVDR, many ctDNA assays—especially those used to inform treatment decisions or stratify patients— maybe classified as higher risk, bringing increased requirements for:2
- Clinical evidence
- Demonstrated performance and reliability
- Ongoing post market surveillance
These changes directly influence assay selection, study design, and long-term development planning.
Defining Intended Use for ctDNA Assays
One of the most important regulatory considerations for ctDNA integration is clearly defining intended use. ctDNA assays may function as:
- Exploratory biomarkers
- Complementary diagnostics
- Companion diagnostics
Each role carries distinct regulatory obligations. Early clarity helps align evidence generation, documentation, and operational planning and can help reduce downstream risk as programs advance.
Evidence Expectations Beyond Analytical Validation
Regulatory authorities increasingly expect ctDNA programs to demonstrate more than analytical sensitivity and specificity. Growing emphasis is placed on clinical relevance and consistency, including:3
- Associations between ctDNA findings and clinical outcomes
- Reproducibility across sites and timepoints
- Clear approaches to managing confounding factors such as clonal hematopoiesis
Embedding these elements into study design supports the generation of regulator-ready data.
Operational Execution as a Regulatory Foundation
Operational consistency is critical to regulatory success. Variability in pre-analytical steps—such as blood collection, processing, or shipment—can compromise data quality and complicate review.
Robust programs emphasize standardized workflows, clear documentation, and alignment across sponsors, CROs, laboratories, and technology collaborators. Regulatory compliance is ultimately driven by disciplined execution across the trial lifecycle.
Preparing for Evolving Global ctDNA Regulations
While IVDR has been a major focus, regulatory expectations for ctDNA are evolving globally. As technologies mature and clinical impact becomes clearer, convergence around higher evidence and quality standards is likely across regions. Programs designed with this trajectory in mind are better positioned to adapt as guidance continues to evolve.
Integrating Regulatory Strategy Into Precision Oncology Planning
The regulatory discussion reinforces a broader theme in precision oncology: ctDNA is increasingly moving beyond an no longer an experimental add-on. Its growing influence on trial design and interpretation means regulatory strategy must be considered early and revisited often.
Aligning intended use, evidence generation, and operational execution from the outset enables teams to integrate ctDNA with confidence—supporting innovation while navigating an increasingly complex regulatory environment.
Continue the Conversation
The scientific and regulatory dimensions of ctDNA are evolving together, reshaping how precision oncology studies are designed and executed. To explore how these considerations can be integrated into your oncology programs—from assay strategy to operational readiness—connect with Fortrea’s oncology team or access the full webinar on demand.
Disclaimer:
This content is intended for general informational purposes only and does not constitute regulatory, scientific, or legal advice. The perspectives reflect the speaker’s views and do not represent formal regulatory guidance or guaranteed outcomes. Regulatory requirements may vary by study jurisdiction, context and design.