ReviewClinical and translational science2019
The Labyrinth of Product Development and Regulatory Approvals in Liquid Biopsy Diagnostics.
Review in Clinical and translational science, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 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
15 citing papers in PubMed.
- Circulating tumour cells for guiding antibody‒drug conjugate therapy: Role of artificial intelligence.Clinical and translational medicine · 2026Review
- Review
- Unlocking the Potential of Liquid Biopsy: A Paradigm Shift in Endometrial Cancer Care.Diagnostics (Basel, Switzerland) · 2025Review
- Enhancing detection and monitoring of circulating tumor cells: Integrative approaches in liquid biopsy advances.The journal of liquid biopsy · 2025Review
- Revolutionising Cardio-Oncology Care with Precision Genomics.International journal of molecular sciences · 2025Review
- A scoping review of factors influencing the implementation of liquid biopsy for cancer care.Journal of experimental & clinical cancer research : CR · 2025Article
- Liquid Biopsy in the Clinical Management of Cancers.International journal of molecular sciences · 2024Review
- Leading the pack: Best practices in comparative canine cancer genomics to inform human oncology.Veterinary and comparative oncology · 2023Review
- Proof of concept: Detection of cell free RNA from EDTA plasma in patients with lung cancer and non-cancer patients.Clinical biochemistry · 2023Article
- Accelerating the Development and Validation of Liquid Biopsy for Early Cancer Screening and Treatment Tailoring.Healthcare (Basel, Switzerland) · 2022Article
- Liquid Biopsy Using Cell-Free or Circulating Tumor DNA in the Management of Hepatocellular Carcinoma.Cellular and molecular gastroenterology and hepatology · 2022Review
- Recommendations for Specimen and Therapy Selection in Colorectal Cancer.Oncology and therapy · 2021Article
- Extracellular Vesicle Molecular Signatures Characterize Metastatic Dynamicity in Ovarian Cancer.Frontiers in oncology · 2021Article
- The regulatory landscape of precision oncology laboratory medicine in the United States - Perspective on the past 5 years and considerations for future regulation.Practical laboratory medicine · 2020Article
- Real-life multidisciplinary treatment for unresectable colorectal cancer liver metastases including hepatic artery infusion with chemo-filtration and liquid biopsy precision oncotherapy: observational cohort study.Journal of cancer research and clinical oncology · 2020Observational
Corrections and comments
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Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The evolution of chemistries and instrument platforms for next-generation sequencing has led to sequencing of genomic variants in both tumor biopsies as well as in circulating tumor cells (CTCs) and cell-free DNA liquid biopsies. The transition of these analytical platforms into clinical ones has led to challenges in product development as well as regulatory strategies for the approval of diagnostic products with these platforms. Regulatory strategies for liquid biopsy diagnostics depend on a framework that has been developed over the past few years by the US Food and Drug Administration (FDA). This framework includes both guidances that cover enrichment biomarkers and companion diagnostics, as well as regulatory approval precedents, which can be used to design regulatory strategies for new liquid biopsy diagnostic products. However, the regulatory paths for these liquid biopsy diagnostics can also be tortuous, as is the example of CTC-platform liquid biopsies. The ultimate success of regulatory pathways of liquid biopsy diagnostics has been driven by the incremental value of FDA approval for Clinical Laboratory Improvement Amendment (CLIA)-developed tests and by the inherent complexity of these diagnostics, which are practical barriers for the widespread replication of these tests throughout CLIA laboratories. The framework for FDA approval of sequence information from these liquid biopsies has been focused on single-site approvals of diagnostics where sequencing information is considered at different diagnostic risk levels, ranging from novel or follow-on companion diagnostics to variant calls in genomic targets considered independently valuable for therapeutic decision making.
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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.