ReviewBiomarker insights2021
Companion Diagnostics: State of the Art and New Regulations.
Review in Biomarker insights, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 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
23 citing papers in PubMed.
- Analytical validation and harmonization of activity-based protease assays: requirements for clinical translation.Analytical and bioanalytical chemistry · 2026Review
- From Precision to Personalized: Catalyzing AI-Enabled Innovation in Drug Development.Clinical and translational science · 2026Article
- Medical biotechnology and artificial intelligence powered companion diagnostics: indispensable pillars driving next generation precision health care.Biotechnology letters · 2026Review
- Molecular Oncodiagnostics in Precision Oncology: Integrating Tumor Transcriptomics, Patient Pharmacogenetics, and Ex Vivo Chemoresistance Testing to Improve Individual Chemotherapy Response.Journal of personalized medicine · 2026Review
- 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
- Genomic innovations in cancer prevention, diagnosis, prognosis and precision therapeutics.Frontiers in genetics · 2026Review
- Antibody-drug conjugates in cancer therapy: current landscape, challenges, and future directions.Molecular cancer · 2025Review
- From Lab to Clinic: Artificial Intelligence with Spectroscopic Liquid Biopsies.Diagnostics (Basel, Switzerland) · 2025Review
- Challenges to Innovation Arising from Current Companion Diagnostic Regulations and Suggestions for Improvements.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Article
- Polymerase Chain Reaction Chips for Biomarker Discovery and Validation in Drug Development.Micromachines · 2025Review
- New Insights into Colorectal Cancer through the Lens of Precision Oncology and Personalized Medicine: Multi-Omics Helps Aging of Predisposed People.Current aging science · 2025Review
- Biomarker understanding first lessons from drug development for IgA-driven autoimmune and fibrotic diseases.Cambridge prisms. Precision medicine · 2025Review
- Insights into post-marketing clinical validation of companion diagnostics with reference to the FDA, EMA, PMDA, and MFDS.Molecular therapy. Methods & clinical development · 2024Review
- Companion Tests and Personalized Cancer Therapy: Reaching a Glass Ceiling.International journal of molecular sciences · 2024Review
- Liquid Liver Biopsy for Disease Diagnosis and Prognosis.Journal of clinical and translational hepatology · 2023Review
- Necessity of strengthening the current clinical regulatory for companion diagnostics: An institutional comparison of the FDA, EMA, and MFDS.Molecular therapy. Methods & clinical development · 2023Review
- The Future of Precision Oncology.International journal of molecular sciences · 2023Review
- A Systematic Database Approach to Identify Companion Diagnostic Testing in Clinical Trials under the New In Vitro Diagnostic Medical Devices Regulation.Diagnostics (Basel, Switzerland) · 2023Article
- Access and reimbursement pathways for digital health solutions andFrontiers in medical technology · 2023Review
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
Companion diagnostics (CDx) hail promise of improving the drug development process and precision medicine. However, there are various challenges involved in the clinical development and regulation of CDx, which are considered high-risk in vitro diagnostic medical devices given the role they play in therapeutic decision-making and the complications they may introduce with respect to their sensitivity and specificity. The European Union (E.U.) is currently in the process of bringing into effect in vitro Diagnostic Medical Devices Regulation (IVDR). The new Regulation is introducing a wide range of stringent requirements for scientific validity, analytical and clinical performance, as well as on post-market surveillance activities throughout the lifetime of in vitro diagnostics (IVD). Compliance with General Safety and Performance Requirements (GSPRs) adopts a risk-based approach, which is also the case for the new classification system. This changing regulatory framework has an impact on all stakeholders involved in the IVD Industry, including Authorized Representatives, Distributors, Importers, Notified Bodies, and Reference Laboratories and is expected to have a significant effect on the development of new CDx.
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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.