Health AI Central
Peer-Reviewed Publication
JCO Precis Oncol2025;9e2500245.November 1, 2025Journal Article

Functional Characterization and a Real-World Clinical Laboratory Pilot of the Foundation for the National Institutes of Health Circulating Tumor DNA Quality Control Materials.

Cloud P Paweletz1, Thomas D Forbes2, Laura Yee3, Grace Heavey1, Hua-Jun He4, Zhiyong He4, Dana Connors5, Daniel Stetson6, Susan Keating7, Kenneth D Cole4, Li Chen2, Rini Pauly2, Hua Bao8, Xue Wu8, Gary A Pestano9, Amanda L Weaver9, Manish Kohli10, Sabine Hellwig11, Adam S Corner12, Andrew M Prantner12, Stephen Q Wong13, Stephen B Fox13, Chelsee A Hewitt13, Rainier Arnolda13, Greg R Jones14, Jonathan Craft15, Melissa McConechy16, Mawath A Qahtani16, Florian Klemm17, Fuad Mohammad17, Caroline Sigman7, Liang-Chun Liu18, Qiang Gan18, Yves Konigshofer19, Russell Garlick19, Ephrem Chin20, Gary Kelloff21, P Mickey Williams2, Robert McCormack22, Chris Karlovich2
1Belfer Center for Applied Cancer Science, Dana-Farber Cancer Institute, Boston, MA.
2Molecular Characterization Laboratory, Frederick National Laboratory for Cancer Research, Frederick, MD.
3Biometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.
4National Institute of Standards and Technology, Gaithersburg, MD.
5Foundation for the National Institutes of Health, Bethesda, MD.
6AstraZeneca Inc, Waltham, MA.
7CCS Associates Inc, San Jose, CA.
8Geneseeq Technology Inc, Toronto, ON, Canada.
9Biodesix Inc, Louisville, CO.
10Huntsman Cancer Institute, University of Utah, Salt Lake City, UT.
11ARUP Laboratories, Salt Lake City, UT.
12Bio-Rad Laboratories Inc, Hercules, CA.
13Peter MacCallum Cancer Centre, Melbourne, Australia.
14NeoGenomics Laboratories Inc, Fort Myers, FL.
15Sysmex Inostics Inc, Baltimore, MD.
16Canexia Health Corp, Vancouver, Canada.
17SOPHiA GENETICS, Rolle, Switzerland.
18Thermo Fisher Scientific Inc, Fremont, CA.
19LGC Clinical Diagnostics, Gaithersburg, MD.
20Revvity, Cambridge, United Kingdom.
21Cancer Imaging Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.
22RMCC LLC, New Hope, PA.
PubMed PMC DOI PDF

Abstract

PURPOSE: We 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. METHODS: QCMs were provided by three manufacturers. To functionally characterize the QCMs, we (1) evaluated EGFR L858R and ex19del (range, 0.5%-5.0% variant allele frequ…

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