ReviewFrontiers in oncology2014
Navigating the rapids: the development of regulated next-generation sequencing-based clinical trial assays and companion diagnostics.
Review in Frontiers in oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
34 citing papers in PubMed.
- Prediction of BRAF and TERT status in PTCs by machine learning-based ultrasound radiomics methods: A multicenter study.Journal of clinical & translational endocrinology · 2025Article
- Analytical Validation and Performance Evaluation of Amplicon-Based Next-Generation Sequencing Assays for DetectingCancers · 2024Article
- Evaluation of pancreatic cancer specimens for comprehensive genomic profiling.Pathology international · 2024Article
- Determinants of targeted cancer therapy use in community oncology practice: a qualitative study using the Theoretical Domains Framework and Rummler-Brache process mapping.Implementation science communications · 2023Article
- New Drug Development and Clinical Trial Design by Applying Genomic Information Management.Pharmaceutics · 2022Review
- Suspicious ultrasound and clinicopathological features of papillary thyroid carcinoma predict the status of TERT promoter.Endocrine · 2020Article
- How Can Law and Policy Advance Quality in Genomic Analysis and Interpretation for Clinical Care?The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2020Article
- An Integrated Next-Generation Sequencing System for Analyzing DNA Mutations, Gene Fusions, and RNA Expression in Lung Cancer.Translational oncology · 2019Article
- Integrating Next-Generation Sequencing in the Clinical Pharmacogenomics Workflow.Frontiers in pharmacology · 2019Review
- Implementing TMB measurement in clinical practice: considerations on assay requirements.ESMO open · 2019Article
- NGmerge: merging paired-end reads via novel empirically-derived models of sequencing errors.BMC bioinformatics · 2018Article
- Understanding preanalytical variables and their effects on clinical biomarkers of oncology and immunotherapy.Seminars in cancer biology · 2018Review
- A machine learning approach for somatic mutation discovery.Science translational medicine · 2018Article
- The Role of Next-Generation Sequencing in Enabling Personalized Oncology Therapy.Clinical and translational science · 2016Article
- Precision Oncology Medicine: The Clinical Relevance of Patient-Specific Biomarkers Used to Optimize Cancer Treatment.Journal of clinical pharmacology · 2016Review
- Future perspectives in melanoma research : Meeting report from the "Melanoma Bridge". Napoli, December 1st-4th 2015.Journal of translational medicine · 2016Article
- Genomic sequencing in clinical practice: applications, challenges, and opportunities.Dialogues in clinical neuroscience · 2016Review
- Plasmid-Based Materials as Multiplex Quality Controls and Calibrators for Clinical Next-Generation Sequencing Assays.The Journal of molecular diagnostics : JMD · 2016Article
- Is Whole-Exome Sequencing an Ethically Disruptive Technology? Perspectives of Pediatric Oncologists and Parents of Pediatric Patients With Solid Tumors.Pediatric blood & cancer · 2016Article
- Genomic characterization of esophageal squamous cell carcinoma: Insights from next-generation sequencing.World journal of gastroenterology · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Over the past decade, next-generation sequencing (NGS) technology has experienced meteoric growth in the aspects of platform, technology, and supporting bioinformatics development allowing its widespread and rapid uptake in research settings. More recently, NGS-based genomic data have been exploited to better understand disease development and patient characteristics that influence response to a given therapeutic intervention. Cancer, as a disease characterized by and driven by the tumor genetic landscape, is particularly amenable to NGS-based diagnostic (Dx) approaches. NGS-based technologies are particularly well suited to studying cancer disease development, progression and emergence of resistance, all key factors in the development of next-generation cancer Dxs. Yet, to achieve the promise of NGS-based patient treatment, drug developers will need to overcome a number of operational, technical, regulatory, and strategic challenges. Here, we provide a succinct overview of the state of the clinical NGS field in terms of the available clinically targeted platforms and sequencing technologies. We discuss the various operational and practical aspects of clinical NGS testing that will facilitate or limit the uptake of such assays in routine clinical care. We examine the current strategies for analytical validation and Food and Drug Administration (FDA)-approval of NGS-based assays and ongoing efforts to standardize clinical NGS and build quality control standards for the same. The rapidly evolving companion diagnostic (CDx) landscape for NGS-based assays will be reviewed, highlighting the key areas of concern and suggesting strategies to mitigate risk. The review will conclude with a series of strategic questions that face drug developers and a discussion of the likely future course of NGS-based CDx development efforts.
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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.