In case you missed it, last week the FDA posted a final guidance on "Use of Circulating Tumor DNA for Curative-Intent Solid Tumor Drug Development".
The guidance covers the use of "circulating cell-free plasma derived tumor DNA (ctDNA) as a biomarker in cancer clinical trials … and/or to support marketing approval of drugs and biological products for treating solid tumor malignancies in the early-stage (curative-intent) setting." It also states that the guidance is not intended for metastatic cancers with the caveat that some aspects may apply.
The guidance has four sections covering the use in clinical trials that include notes on the aspects of the assays and recommended actions based on assay results:
1. ctDNA for Patient Selection based on Molecular Alteration
2. ctDNA Molecular Residual Disease for Patient Enrichment
3. ctDNA as a Measure of Response for Drug Development
4. ctDNA as an Early Endpoint in Clinical Trials:
Due to the importance of the assays, a large section covers the types of assays (NGS and WGS), collection of the samples, and critical aspects of the assay validation. Most of the four uses defined above (e.g., patient inclusion/exclusion, endpoint) do require the assay to be performed in CLIA labs. If the assay is to be used post-marketing, it does recommend discussions with CDRH on the assay/device and what is needed to obtain approval.
#fda #ctDNA #SolidTumorBiomarker
https://www.fda.gov/media/183874/download
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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