ArticleDiagnostics (Basel, Switzerland)2021
Can Circulating Tumor DNA Support a Successful Screening Test for Early Cancer Detection? The Grail Paradigm.
Article in Diagnostics (Basel, Switzerland), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.
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Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.
- Multi-cancer early detection tests for general population screening: a systematic literature review.Health technology assessment (Winchester, England) · 2025Pooled it
- Pancreatic Cancer Early Detection Biomarkers for High-Risk Individuals: Insights From the PRECEDE Consortium.International journal of cancer · 2026Review
- The role of circulating tumor DNA in ovarian cancer.Discover oncology · 2026Review
- Fragmentomic liquid biopsy enables early breast cancer detection, molecular subtyping and lymph node assessment.Nature communications · 2026Article
- Diagnostics of lung cancer by fragmentated blood circulating cell-free DNA based on machine learning methods.Frontiers in medicine · 2025Article
- Integrating artificial intelligence with circulating tumor DNA for non-small cell lung cancer: opportunities, challenges, and future directions.Frontiers in medicine · 2025Review
- Spatial transcriptomic analysis drives PET imaging of tight junction protein expression in pancreatic cancer theranostics.Nature communications · 2024Article
- Recent Advancements in the Application of Circulating Tumor DNA as Biomarkers for Early Detection of Cancers.ACS biomaterials science & engineering · 2024Review
- Early detection of pancreatic cancer by liquid biopsy "PANLIPSY": a french nation-wide study project.BMC cancer · 2024Observational
- Evaluating the comprehensive diagnosis efficiency of lung cancer, including measurement of SHOX2 and RASSF1A gene methylation.BMC cancer · 2024Article
- Circulating Tumor DNA Is a Variant of Liquid Biopsy with Predictive and Prognostic Clinical Value in Breast Cancer Patients.International journal of molecular sciences · 2023Review
- Global serum profiling: an opportunity for earlier cancer detection.Journal of experimental & clinical cancer research : CR · 2023Review
- Cell-Free Nucleic Acids: Physico-Chemical Properties, Analytical Considerations, and Clinical Applications.Diagnostics (Basel, Switzerland) · 2023Article
- Liquid Biopsies, Novel Approaches and Future Directions.Cancers · 2023Review
- Framework for Adoption of Next-Generation Sequencing (NGS) Globally in the Oncology Area.Healthcare (Basel, Switzerland) · 2023Article
- Circulating DNA fragmentomics and cancer screening.Cell genomics · 2023Review
- Case Report: Early detection of pancreatic pre-cancer lesion in multimodal approach with exosome liquid biopsy.Frontiers in oncology · 2023Article
- High Grade Anal Dysplasia in People Living with HIV: A Review of the Anal Cancer/HSIL Outcomes Research (ANCHOR) Trial. Implications for Screening and Treatment Strategies to Minimize Anal Cancer in a Very High-risk Population.International journal of cancer care and delivery · 2023Article
- New Perspectives on the Importance of Cell-Free DNA Biology.Diagnostics (Basel, Switzerland) · 2022Review
- The Early Detection of Breast Cancer Using Liquid Biopsies: Model Estimates of the Benefits, Harms, and Costs.Cancers · 2022Article
Corrections and comments
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Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Circulating tumor DNA (ctDNA) is a new pan-cancer tumor marker with important applications for patient prognosis, monitoring progression, and assessing the success of the therapeutic response. Another important goal is an early cancer diagnosis. There is currently a debate if ctDNA can be used for early cancer detection due to the small tumor burden and low mutant allele fraction (MAF). We compare our previous calculations on the size of detectable cancers by ctDNA analysis with the latest experimental data from Grail's clinical trial. Current ctDNA-based diagnostic methods could predictably detect tumors of sizes greater than 10-15 mm in diameter. When tumors are of this size or smaller, their MAF is about 0.01% (one tumor DNA molecule admixed with 10,000 normal DNA molecules). The use of 10 mL of blood (4 mL of plasma) will likely contain less than a complete cancer genome, thus rendering the diagnosis of cancer impossible. Grail's new data confirm the low sensitivity for early cancer detection (<30% for Stage I-II tumors, <20% for Stage I tumors), but specificity was high at 99.5%. According to these latest data, the sensitivity of the Grail test is less than 20% in Stage I disease, casting doubt if this test could become a viable pan-cancer clinical screening tool.
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