An ultrasensitive method for quantitating circulating tumor DNA with broad patient coverage
Open accessAbstract
Circulating tumor DNA (ctDNA) is a promising biomarker for noninvasive assessment of cancer burden, but existing ctDNA detection methods have insufficient sensitivity or patient coverage for broad clinical applicability. Here we introduce cancer personalized profiling by deep sequencing (CAPP-Seq), an economical and ultrasensitive method for quantifying ctDNA. We implemented CAPP-Seq for non-small-cell lung cancer (NSCLC) with a design covering multiple classes of somatic alterations that identified mutations in >95% of tumors. We detected ctDNA in 100% of patients with stage II-IV NSCLC and in 50% of patients with stage I, with 96% specificity for mutant allele fractions down to ∼0.02%. Levels of ctDNA were highly correlated with tumor volume and distinguished between residual disease and treatment-related imaging changes, and measurement of ctDNA levels allowed for earlier response assessment than radiographic approaches. Finally, we evaluated biopsy-free tumor screening and genotyping with CAPP-Seq. We envision that CAPP-Seq could be routinely applied clinically to detect and monitor diverse malignancies, thus facilitating personalized cancer therapy.
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Next-generation sequencing of circulating tumor DNA in plasma using ultra-sensitive sequencing technologies with a short turn-around time has facilitated increased detection.
“Next-generation sequencing of circulating tumor DNA in plasma samples using ultra-sensitive sequencing technologies with a short turn-around time have facilitated increased detection70.”
From Selective KRAS G12C inhibitors in non-small cell lung cancer: chemistry, concurrent pathway alterations, and clinical outcomes (2021) · cites this paper as [70]
ctDNA can be readily detected in advanced NSCLC patients, and sensitive genotyping assays can detect mutations in ctDNA.
“ctDNA can be readily detected in advanced NSCLC patients, and several studies have shown that highly sensitive genotyping assays can detect mutations in ctDNA (20–26).”
ctDNA is readily detectable in lung cancer patient blood.
“Moreover, ctDNA is readily detectable in lung cancer patient blood (20, 27, 29, 30), and sensitivity of variant detection was recently shown to be higher in ctDNA than CTCs (25).”
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- Authors
- Newman, A. M., Bratman, S. V., To, J., Wynne, J. F., Eclov, N. C. W., Modlin, L. A., Liu, C. L., Neal, J. W., Wakelee, H. A., Merritt, R. E., Shrager, J. B., Loo, B. W., Alizadeh, A. A., & Diehn, M.
- Affiliations
- Stanford Cancer Institute (US)
- Institute for Stem Cell Biology and Regenerative Medicine (US)
- Stanford University (US)
- Stanford Medicine (US)
- Corresponding author
- Alizadeh, Ash A
- Diehn, Maximilian
- ORCID
- Venue
- Nature Medicine
- Published
- 2014-04-06
- Volume
- 20
- Issue
- 5
- Pages
- 548-554
- ISSN
- 1078-8956 (ISSN-L)
- 1546-170X
- PMC
- PMC4016134
- OpenAlex
- W1983466841
- Cited by
- 2,220
- References
- 59
- Citations by year
- 2026: 104 · 2025: 143 · 2024: 129 · 2023: 201 · 2022: 207 · 2021: 243 · 2020: 248 · 2019: 214 · 2018: 223 · 2017: 216 · 2016: 152 · 2015: 102 · 2014: 33 · 2013: 1
- FWCI
- 53.75
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Nature Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Cancer Institute (1-DP2-CA186569, DP2CA186569, T32CA009302)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer Genomics and Diagnostics
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Prenatal Screening and Diagnostics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Circular RNAs in diseases
- Keywords
- circulating tumor DNA, CAPP-Seq, liquid biopsy, non-small cell lung cancer, somatic mutations, tumor volume, treatment response assessment, tumor genotyping, precision oncology, early-stage cancer detection
- MeSH terms
- Carcinoma, Non-Small-Cell Lung, DNA, Neoplasm, Humans, Neoplastic Cells, Circulating, Neoplasm Staging, Neoplasms, Biomarkers, Tumor, High-Throughput Nucleotide Sequencing
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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