ArticleClinical cancer research : an official journal of the American Association for Cancer Research2025
Challenges to Innovation Arising from Current Companion Diagnostic Regulations and Suggestions for Improvements.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 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
10 citing papers in PubMed.
- Oncometabolites in Cancer Metabolism: Mechanistic Insights and Biomarker Potential- A Narrative Review.Health science reports · 2026Article
- Chronotherapy in Hematological Malignancies: Evaluating the Rationale and Evidence.Pharmacology research & perspectives · 2026Review
- Strategic Integration of Companion Diagnostics in Precision Oncology: Key Factors, Drug Development Timelines, and Regulatory Insights from U.S. FDA Approvals.Therapeutic innovation & regulatory science · 2026Article
- Regulating complexity in AI-enabled omics and multi-omics technologies for precision medicine.NPJ digital medicine · 2026Article
- Companion Diagnostics in Clinical Therapy: Current Applications and Future Directions.MedComm · 2026Review
- Milestone to Ensure Safety and Efficacy of Companion Diagnostic (CDx) That Support Treatment Decisions in Cancer Patients.Diagnostics (Basel, Switzerland) · 2026Review
- Precision immunopharmacology in peri-implantitis management: from molecular mechanisms to advanced therapeutic strategies.Frontiers in immunology · 2026Review
- Advancing equitable access to innovation in breast cancer.NPJ breast cancer · 2025Article
- PD-L1 Expression in NSCLC: Clouds in a Bright Sky.International journal of molecular sciences · 2025Review
- Biomarker understanding first lessons from drug development for IgA-driven autoimmune and fibrotic diseases.Cambridge prisms. Precision medicine · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A companion diagnostic is a diagnostic test that provides information essential for the safe and effective use of a corresponding therapeutic product. To obtain marketing approval, the companion diagnostic must demonstrate acceptable analytical and clinical performance. Companion diagnostic regulations are intended to protect patients by ensuring quality and consistency of treatment-guiding biomarker testing in clinical trials and clinical practice. However, current regulations have had unintended negative consequences relating to innovation, implementation, and accessibility of precision medicine; increasing complexity and cost burden; and inhibiting development of novel diagnostics and biomarker-targeted therapeutics. We propose a range of practical solutions to these challenges, advocating that regulators, pharmaceutical companies, molecular pathologist groups, and diagnostic companies work together to increase flexibility and promote diagnostic innovation, while maintaining high-quality diagnostic testing to ensure all patients get the most appropriate treatments.
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Identifiers
What OpenQuestion holds
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.