ctDNA – Out of the Dark
Review of Draft Guidance 2022
Circulating tumor DNA (ctDNA) is tumor-derived fragmented DNA in the bloodstream that is not associated with cells. ctDNA should not be confused with cell-free DNA (cfDNA), a broader term which describes DNA that is freely circulating in the bloodstream, but is not necessarily of tumor origin. Because ctDNA may reflect the entire tumor genome, it has gained traction for its potential clinical utility; “liquid biopsies” in the form of blood draws may be taken at various time points to monitor tumor progression throughout the treatment regimen.[1]
July 21 Meeting
Meeting slides
Content:
Search for FDA Guidances (link)
Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment Guidance for Industry (link) (download)
Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (link) (download)
Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products Guidance for Industry (link) (download)
Summary of Safety and Effectiveness Data (SSED) PMA #P200010 (link) (download)
Investigational Device Exemptions (link)
Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors (download)
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (download)
Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination (link) (download)
Circulating cell-free plasma derived tumor DNA (ctDNA) can be used as a biomarker in cancer (e.g., in clinical trials) and or for treating solid tumor malignancies in the early-stage setting. In May 2022, the FDA released a draft guidance entitled ”Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development Guidance for Industry”.
Excellent resources:
Friends of Cancer Research ctMoniTR Project
Liquid biopsy: a step closer to transform diagnosis, prognosis and future of cancer treatments (download)
Image Credit: Friends of Cancer Research
Link to Dr. Quinn’s blog here
In this new white paper from Bruce Quinn, he provides an update on recent publications on plasma-based comprehensive genotyping, including health economics. He also reviews the status of PLA coding and Category I coding in detail. He argues that it is time for bringing the coding system up-to-date.
In this project, we will review the draft guidance and discuss relevant aspects. By soliciting input from various stakeholders we will provide a
A brief summary of the document
Provide relevant references
Consider providing feedback / comments on the draft guidance
The main aim of this project is to increase clarity on an evolving and important topic.
DISCLAIMER ABOUT THIS PROJECT
a) This project has not been specifically authorized by the FDA
b) This project and content here will reflect the majority consensus and contributions from many non-FDA stakeholders, solicited through a public convening. While many have contributed, it is challenging to encompass all viewpoints. We welcome additional comments and/or participation via email: digipathalliance@gmail.com
c) The focus of PIcc is regulatory science