Guardant360 Circulating Tumor DNA Assay Is Concordant with FoundationOne Next-Generation Sequencing in Detecting Actionable Driver Mutations in Anti-EGFR Naive Metastatic Colorectal Cancer
Open accessAbstract
Background: Direct comparisons between Guardant360 (G360) circulating tumor DNA (ctDNA) and FoundationOne (F1) tumor biopsy genomic profiling in metastatic colorectal cancer (mCRC) are limited. We aim to assess the concordance across overlapping genes tested in both F1 and G360 in patients with mCRC. Materials and Methods: We retrospectively analyzed 75 patients with mCRC who underwent G360 and F1 testing. We evaluated the concordance among gene mutations tested by both G360 and F1 among three categories of patients: untreated, treated without, and treated with EGFR inhibitors, while considering the clonal and/or subclonal nature of each genomic alteration. Results: There was a high rate of concordance in APC, TP53, KRAS, NRAS, and BRAF mutations in the treatment-naive and non–anti-EGFR-treated cohorts. There was increased discordance in the anti-EGFR treated patients in three drivers of anti-EGFR resistance: KRAS, NRAS, and EGFR somatic mutations. Based on percentage of ctDNA, discordant somatic mutations were mostly subclonal instead of clonal and may have limited clinical significance. Most discordant amplifications noted on G360 showed the magnitude below the top decile, occurred in all three cohorts of patients, and were of unknown clinical significance. Serial ctDNA in anti-EGFR treated patients showed the emergence of multiple new alterations that affected the EGFR pathway: EGFR and RAS mutations and MET, RAS, and BRAF amplifications. Conclusion: G360 Next-Generation Sequencing platform may be used as an alternative to F1 to detect targetable somatic alterations in non–anti-EGFR treated mCRC, but larger prospective studies are needed to further validate our findings.
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Higher rates of BRAF copy number variants have been observed in other colorectal cancer studies employing blood-based sequencing.
“Higher rates of BRAF copy number variants have been observed in other colorectal cancer studies employing blood-based sequencing. 29,30”
From Sotorasib with panitumumab in chemotherapy-refractory KRASG12C-mutated colorectal cancer: a phase 1b trial (2024) · cites this paper as [30]
The Genomic Landscape section (page unavailable) reports BRAF amplifications in three patients tested with the blood-based Guardant360 assay and says Guardant360 reported more amplifications overall than tissue-based FoundationOne. It does not establish a specifically higher rate of BRAF copy-number variants, so the comparative part of the claim is unsupported. (LLM, conf=0.82)
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Additional file 3 of Inter-assay variability of next-generation sequencing-based gene panels
Quy, P. N., Fukuyama, K., Kanai, M., Kou, T., Kondo, T., Yoshioka, M., Matsubara, J., Sakuma, T., Minamiguchi, S., Matsumoto, S., et al. (2022) · Figshare · doi:10.6084/m9.figshare.19607773
Additional file 4 of Inter-assay variability of next-generation sequencing-based gene panels
Quy, P. N., Fukuyama, K., Kanai, M., Kou, T., Kondo, T., Yoshioka, M., Matsubara, J., Sakuma, T., Minamiguchi, S., Matsumoto, S., et al. (2022) · Figshare · doi:10.6084/m9.figshare.19607776
Additional file 1 of Inter-assay variability of next-generation sequencing-based gene panels
Quy, P. N., Fukuyama, K., Kanai, M., Kou, T., Kondo, T., Yoshioka, M., Matsubara, J., Sakuma, T., Minamiguchi, S., Matsumoto, S., et al. (2022) · Figshare · doi:10.6084/m9.figshare.19607767
Additional file 12 of Inter-assay variability of next-generation sequencing-based gene panels
Quy, P. N., Fukuyama, K., Kanai, M., Kou, T., Kondo, T., Yoshioka, M., Matsubara, J., Sakuma, T., Minamiguchi, S., Matsumoto, S., et al. (2022) · Figshare · doi:10.6084/m9.figshare.19607761
Additional file 10 of Inter-assay variability of next-generation sequencing-based gene panels
Quy, P. N., Fukuyama, K., Kanai, M., Kou, T., Kondo, T., Yoshioka, M., Matsubara, J., Sakuma, T., Minamiguchi, S., Matsumoto, S., et al. (2022) · Figshare · doi:10.6084/m9.figshare.19607755
Additional file 5 of Inter-assay variability of next-generation sequencing-based gene panels
Quy, P. N., Fukuyama, K., Kanai, M., Kou, T., Kondo, T., Yoshioka, M., Matsubara, J., Sakuma, T., Minamiguchi, S., Matsumoto, S., et al. (2022) · Figshare · doi:10.6084/m9.figshare.19607779
Additional file 6 of Inter-assay variability of next-generation sequencing-based gene panels
Quy, P. N., Fukuyama, K., Kanai, M., Kou, T., Kondo, T., Yoshioka, M., Matsubara, J., Sakuma, T., Minamiguchi, S., Matsumoto, S., et al. (2022) · Figshare · doi:10.6084/m9.figshare.19607782
Additional file 8 of Inter-assay variability of next-generation sequencing-based gene panels
Quy, P. N., Fukuyama, K., Kanai, M., Kou, T., Kondo, T., Yoshioka, M., Matsubara, J., Sakuma, T., Minamiguchi, S., Matsumoto, S., et al. (2022) · Figshare · doi:10.6084/m9.figshare.19607788
Additional file 9 of Inter-assay variability of next-generation sequencing-based gene panels
Quy, P. N., Fukuyama, K., Kanai, M., Kou, T., Kondo, T., Yoshioka, M., Matsubara, J., Sakuma, T., Minamiguchi, S., Matsumoto, S., et al. (2022) · Figshare · doi:10.6084/m9.figshare.19607791
Additional file 13 of Inter-assay variability of next-generation sequencing-based gene panels
Quy, P. N., Fukuyama, K., Kanai, M., Kou, T., Kondo, T., Yoshioka, M., Matsubara, J., Sakuma, T., Minamiguchi, S., Matsumoto, S., et al. (2022) · Figshare · doi:10.6084/m9.figshare.19607764
Additional file 2 of Inter-assay variability of next-generation sequencing-based gene panels
Quy, P. N., Fukuyama, K., Kanai, M., Kou, T., Kondo, T., Yoshioka, M., Matsubara, J., Sakuma, T., Minamiguchi, S., Matsumoto, S., et al. (2022) · Figshare · doi:10.6084/m9.figshare.19607770
Additional file 11 of Inter-assay variability of next-generation sequencing-based gene panels
Quy, P. N., Fukuyama, K., Kanai, M., Kou, T., Kondo, T., Yoshioka, M., Matsubara, J., Sakuma, T., Minamiguchi, S., Matsumoto, S., et al. (2022) · Figshare · doi:10.6084/m9.figshare.19607758
Additional file 7 of Inter-assay variability of next-generation sequencing-based gene panels
Quy, P. N., Fukuyama, K., Kanai, M., Kou, T., Kondo, T., Yoshioka, M., Matsubara, J., Sakuma, T., Minamiguchi, S., Matsumoto, S., et al. (2022) · Figshare · doi:10.6084/m9.figshare.19607785
Detection of Ovarian High-Grade Serous Carcinoma through Mitochondrial Gene Variation
Li, W., Hao, C., & Zhang, M. (2021) · Bulletin of pioneering researches of medical and clinical science · doi:10.51847/i2gdl8vpw9
Introduction to Biosensing Devices
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Cancer Genomic Medicine for Urological Malignancies in Japan
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Artificial intelligence in oncology: An introduction
Khan, N. A., Mahajan, A. A., Tendulkar, D., Das, N. R., Mondal, S., Dey, A., Ghosh, S., & Rashid, G. (2026) · Elsevier eBooks · doi:10.1016/b978-0-443-45004-4.00008-6
Nejatinejad, M., Maleki-Aram, A., Bigloo, A. N. A., Vahedi, C., Panahian, A., Ebrahimi, A., Yaghoubi, R., Parsaei, H., Vafaei, S., & Jafari, D. (2026) · Clinica Chimica Acta · doi:10.1016/j.cca.2026.121178
AI-Driven Innovations in Cancer Care: A Comprehensive Overview
Li, J., Yeang, H. A., & Perera, R. (2026) · Springer eBooks · doi:10.1007/978-3-032-11023-7_6
- Authors
- Gupta, R., Othman, T., Chen, C., Sandhu, J., Ouyang, C., & Fakih, M.
- Affiliations
- City Of Hope National Medical Center (US)
- University of California, Los Angeles (US)
- Corresponding author
- Fakih, Marwan
- Venue
- The Oncologist
- Publisher
- Oxford University Press (OUP)
- Published
- 2019-11-19
- Volume
- 25
- Issue
- 3
- Pages
- 235-243
- ISSN
- 1083-7159 (ISSN-L)
- 1549-490X
- PMC
- PMC7066697
- OpenAlex
- W2983584265
- Cited by
- 70
- References
- 38
- Citations by year
- 2026: 9 · 2025: 8 · 2024: 2 · 2023: 9 · 2022: 24 · 2021: 13 · 2020: 4 · 2019: 1
- FWCI
- 4.39
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
- Locations
- The Oncologist (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer Genomics and Diagnostics
- Health Sciences › Medicine › Pathology and Forensic Medicine › Genetic factors in colorectal cancer
- Keywords
- circulating tumor DNA, Guardant360, FoundationOne, metastatic colorectal cancer, anti-EGFR therapy, EGFR inhibitors, actionable driver mutations, concordance, subclonal mutations, KRAS mutation, NRAS mutation, EGFR mutation, BRAF amplification, MET amplification, liquid biopsy, EGFR resistance
- MeSH terms
- Circulating Tumor DNA, Colonic Neoplasms, Humans, Mutation, Prospective Studies, Retrospective Studies, Biomarkers, Tumor, Colorectal Neoplasms, High-Throughput Nucleotide Sequencing
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