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Diagnostics
Volume 14
Issue 9
10.3390/diagnostics14090912
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Communication

Advancing Evidence Generation for Circulating Tumor DNA: Lessons Learned from A Multi-Assay Study of Baseline Circulating Tumor DNA Levels across Cancer Types and Stages

by
Brittany A. McKelvey
1,*,
Hillary S. Andrews
1,
Frederick L. Baehner
2,
James Chen
3,
Carin R. Espenschied
4,
David Fabrizio
5,
Vanessa Gorton
6,
Claire Gould
7,
Justin Guinney
3,
Greg Jones
8,
Xiangyang Lv
9,
Michael S. Nahorski
8,
Melanie R. Palomares
2,
Gary A. Pestano
7,
Mark Sausen
10,
Alain Silk
3,
Nicole Zhang
4,
Zhihong Zhang
9,
Mark D. Stewart
1 and
Jeff D. Allen
1
1
Friends of Cancer Research, Washington, DC 20036, USA
2
Exact Sciences Corp., Madison, WI 53719, USA
3
Tempus AI, Inc., Chicago, IL 60654, USA
4
Guardant Health, Inc., Redwood City, CA 94063, USA
5
Foundation Medicine, Inc., Cambridge, MA 02141, USA
6
Predicine, Hayward, CA 94545, USA
7
Biodesix Inc., Louisville, CO 80027, USA
8
NeoGenomics Laboratories, Fort Myers, FL 33912, USA
9
Burning Rock, Irvine, CA 92617, USA
10
Personal Genome Diagnostics, Labcorp, Baltimore, MD 21224, USA
*
Author to whom correspondence should be addressed.
Diagnostics 2024, 14(9), 912; https://doi.org/10.3390/diagnostics14090912
Submission received: 14 March 2024 / Revised: 16 April 2024 / Accepted: 25 April 2024 / Published: 27 April 2024
(This article belongs to the Special Issue Emerging Biomarkers of Clinical Diagnosis)
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Abstract

Circulating tumor DNA (ctDNA) holds promise as a biomarker for predicting clinical responses to therapy in solid tumors, and multiple ctDNA assays are in development. However, the heterogeneity in ctDNA levels prior to treatment (baseline) across different cancer types and stages and across ctDNA assays has not been widely studied. Friends of Cancer Research formed a collaboration across multiple commercial ctDNA assay developers to assess baseline ctDNA levels across five cancer types in early- and late-stage disease. This retrospective study included eight commercial ctDNA assay developers providing summary-level de-identified data for patients with non-small cell lung cancer (NSCLC), bladder, breast, prostate, and head and neck squamous cell carcinoma following a common analysis protocol. Baseline ctDNA levels across late-stage cancer types were similarly detected, highlighting the potential use of ctDNA as a biomarker in these cancer types. Variability was observed in ctDNA levels across assays in early-stage NSCLC, indicative of the contribution of assay analytical performance and methodology on variability. We identified key data elements, including assay characteristics and clinicopathological metadata, that need to be standardized for future meta-analyses across multiple assays. This work facilitates evidence generation opportunities to support the use of ctDNA as a biomarker for clinical response.
Keywords: ctDNA; cancer; biomarker ctDNA; cancer; biomarker

Share and Cite

MDPI and ACS Style

McKelvey, B.A.; Andrews, H.S.; Baehner, F.L.; Chen, J.; Espenschied, C.R.; Fabrizio, D.; Gorton, V.; Gould, C.; Guinney, J.; Jones, G.; et al. Advancing Evidence Generation for Circulating Tumor DNA: Lessons Learned from A Multi-Assay Study of Baseline Circulating Tumor DNA Levels across Cancer Types and Stages. Diagnostics 2024, 14, 912. https://doi.org/10.3390/diagnostics14090912

AMA Style

McKelvey BA, Andrews HS, Baehner FL, Chen J, Espenschied CR, Fabrizio D, Gorton V, Gould C, Guinney J, Jones G, et al. Advancing Evidence Generation for Circulating Tumor DNA: Lessons Learned from A Multi-Assay Study of Baseline Circulating Tumor DNA Levels across Cancer Types and Stages. Diagnostics. 2024; 14(9):912. https://doi.org/10.3390/diagnostics14090912

Chicago/Turabian Style

McKelvey, Brittany A., Hillary S. Andrews, Frederick L. Baehner, James Chen, Carin R. Espenschied, David Fabrizio, Vanessa Gorton, Claire Gould, Justin Guinney, Greg Jones, and et al. 2024. "Advancing Evidence Generation for Circulating Tumor DNA: Lessons Learned from A Multi-Assay Study of Baseline Circulating Tumor DNA Levels across Cancer Types and Stages" Diagnostics 14, no. 9: 912. https://doi.org/10.3390/diagnostics14090912

APA Style

McKelvey, B. A., Andrews, H. S., Baehner, F. L., Chen, J., Espenschied, C. R., Fabrizio, D., Gorton, V., Gould, C., Guinney, J., Jones, G., Lv, X., Nahorski, M. S., Palomares, M. R., Pestano, G. A., Sausen, M., Silk, A., Zhang, N., Zhang, Z., Stewart, M. D., & Allen, J. D. (2024). Advancing Evidence Generation for Circulating Tumor DNA: Lessons Learned from A Multi-Assay Study of Baseline Circulating Tumor DNA Levels across Cancer Types and Stages. Diagnostics, 14(9), 912. https://doi.org/10.3390/diagnostics14090912

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