ArticleJCO precision oncology2025
Functional Characterization and a Real-World Clinical Laboratory Pilot of the Foundation for the National Institutes of Health Circulating Tumor DNA Quality Control Materials.
Article in JCO precision oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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40 authors.
Funding
Abstract
purposeWe previously developed quality control materials (QCMs) to aid in the development of circulating tumor DNA (ctDNA) assays. In this study, we further characterize the performance of the QCMs relative to clinical samples.
methodsQCMs were provided by three manufacturers. To functionally characterize the QCMs, we (1) evaluated
resultsFor functional characterization, part 1, QCM VAFs for hybrid capture were similar to ddPCR for
conclusionThis project revealed unexpected differences in performance of both assays and QCMs. These findings highlight the need for further validation across diverse alteration types and merit consideration by laboratories that rely on QCMs to develop and perform ctDNA assays for diagnostic applications.
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