Challenges to innovation arising from current companion diagnostics regulations and suggestions for improvements

IF 10 1区医学 Q1 ONCOLOGY

Clinical Cancer Research Pub Date : 2024-12-26 DOI:10.1158/1078-0432.ccr-24-2729

Kelly S. Oliner, Michelle Shiller, Peter Schmid, Marianne J. Ratcliffe, Aaron J. Schetter, Ming-Sound Tsao

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引用次数: 0

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 as well as 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 diagnostics companies work together to increase flexibility and promote diagnostic innovation, whilst maintaining high quality diagnostic testing to ensure all patients get the most appropriate treatments.

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来源期刊

Clinical Cancer Research 医学-肿瘤学

CiteScore

20.10

自引率

1.70%

发文量

1207

审稿时长

2.1 months

期刊介绍： Clinical Cancer Research is a journal focusing on groundbreaking research in cancer, specifically in the areas where the laboratory and the clinic intersect. Our primary interest lies in clinical trials that investigate novel treatments, accompanied by research on pharmacology, molecular alterations, and biomarkers that can predict response or resistance to these treatments. Furthermore, we prioritize laboratory and animal studies that explore new drugs and targeted agents with the potential to advance to clinical trials. We also encourage research on targetable mechanisms of cancer development, progression, and metastasis.