ArticlePloS one2018
Analytical validation of a next generation sequencing liquid biopsy assay for high sensitivity broad molecular profiling.
Article in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 59 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
59 citing papers in PubMed, 96 citations in OpenAlex.
- Adjuvant nivolumab, capecitabine or the combination in patients with residual triple-negative breast cancer: the OXEL randomized phase II study.Nature communications · 2024Trial
- Personalized circulating tumor DNA dynamics inform survival and response to immune checkpoint blockade in recurrent/metastatic head and neck cancer.NPJ precision oncology · 2025Article
- Liquid biopsy in gallbladder carcinoma: Current evidence and future prospective.The journal of liquid biopsy · 2024Review
- Optimizing ctDNA: An Updated Review of a Promising Clinical Tool for the Management of Uveal Melanoma.Cancers · 2024Review
- Review
- Oncogenic alterations in advanced NSCLC: a molecular super-highway.Biomarker research · 2024Review
- Adjuvant nivolumab, capecitabine or the combination in patients with residual triple-negative breast cancer: the OXEL randomized phase II study.medRxiv : the preprint server for health sciences · 2023Article
- Using cfDNA and ctDNA as Oncologic Markers: A Path to Clinical Validation.International journal of molecular sciences · 2023Review
- High Yield of Pleural Cell-Free DNA for Diagnosis of Oncogenic Mutations in Lung Adenocarcinoma.Chest · 2023Article
- Comparison of tumor-informed and tumor-naïve sequencing assays for ctDNA detection in breast cancer.EMBO molecular medicine · 2023Article
- Liquid Biopsies, Novel Approaches and Future Directions.Cancers · 2023Review
- High- or low-dose preoperative ipilimumab plus nivolumab in stage III urothelial cancer: the phase 1B NABUCCO trial.Nature medicine · 2023Article
- Liquid Biopsies in Lung Cancer.Cancers · 2023Review
- Circulating Tumor DNA and Late Recurrence in High-Risk Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022Article
- Review
- Residual ctDNA after treatment predicts early relapse in patients with early-stage non-small cell lung cancer.Annals of oncology : official journal of the European Society for Medical Oncology · 2022Article
- Liquid BIOpsy for MiNimal RESidual DiSease Detection in Head and Neck Squamous Cell Carcinoma (LIONESS)-a personalised circulating tumour DNA analysis in head and neck squamous cell carcinoma.British journal of cancer · 2022Article
- Review
- Exploring the Feasibility of Utilizing Limited Gene Panel Circulating Tumor DNA Clearance as a Biomarker in Patients With Locally Advanced Non-Small Cell Lung Cancer.Frontiers in oncology · 2022Article
- The value of cell-free circulating tumour DNA profiling in advanced non-small cell lung cancer (NSCLC) management.Cancer cell international · 2021Review
Corrections and comments
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Authors and funding
25 authors at 2 institutions in 2 countries.
Funding
Abstract
Circulating tumor DNA (ctDNA) analysis is being incorporated into cancer care; notably in profiling patients to guide treatment decisions. Responses to targeted therapies have been observed in patients with actionable mutations detected in plasma DNA at variant allele fractions (VAFs) below 0.5%. Highly sensitive methods are therefore required for optimal clinical use. To enable objective assessment of assay performance, detailed analytical validation is required. We developed the InVisionFirst™ assay, an assay based on enhanced tagged amplicon sequencing (eTAm-Seq™) technology to profile 36 genes commonly mutated in non-small cell lung cancer (NSCLC) and other cancer types for actionable genomic alterations in cell-free DNA. The assay has been developed to detect point mutations, indels, amplifications and gene fusions that commonly occur in NSCLC. For analytical validation, two 10mL blood tubes were collected from NSCLC patients and healthy volunteer donors. In addition, contrived samples were used to represent a wide spectrum of genetic aberrations and VAFs. Samples were analyzed by multiple operators, at different times and using different reagent Lots. Results were compared with digital PCR (dPCR). The InVisionFirst assay demonstrated an excellent limit of detection, with 99.48% sensitivity for SNVs present at VAF range 0.25%-0.33%, 92.46% sensitivity for indels at 0.25% VAF and a high rate of detection at lower frequencies while retaining high specificity (99.9997% per base). The assay also detected ALK and ROS1 gene fusions, and DNA amplifications in ERBB2, FGFR1, MET and EGFR with high sensitivity and specificity. Comparison between the InVisionFirst assay and dPCR in a series of cancer patients showed high concordance. This analytical validation demonstrated that the InVisionFirst assay is highly sensitive, specific and robust, and meets analytical requirements for clinical applications.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.