Translation of proteomic biomarkers into FDA approved cancer diagnostics: issues and challenges

Clinical Proteomics

Daniel W Chan¹  Maria M Chan³  Joshua Levin³  Anna K Füzéry² 

[1] Center for Biomarker Discovery, Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, MD 21231, USA;Current address: Department of Pathology and Laboratory Medicine, Royal Alexandra Hospital, Diagnostic Treatment Center, Room 5047, Edmonton, AB T5H 3V9, Canada;Division of Immunology and Hematology Devices, Office of In Vitro Diagnostic Devices and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA

关键词: Food and drug administration;    Clinical performance;    Analytical performance;    Proteomic biomarker;   

Others  :  1026337
DOI  :  10.1186/1559-0275-10-13

 received in 2013-04-23, accepted in 2013-08-31,  发布年份 2013

【 摘 要 】

Tremendous efforts have been made over the past few decades to discover novel cancer biomarkers for use in clinical practice. However, a striking discrepancy exists between the effort directed toward biomarker discovery and the number of markers that make it into clinical practice. One of the confounding issues in translating a novel discovery into clinical practice is that quite often the scientists working on biomarker discovery have limited knowledge of the analytical, diagnostic, and regulatory requirements for a clinical assay. This review provides an introduction to such considerations with the aim of generating more extensive discussion for study design, assay performance, and regulatory approval in the process of translating new proteomic biomarkers from discovery into cancer diagnostics. We first describe the analytical requirements for a robust clinical biomarker assay, including concepts of precision, trueness, specificity and analytical interference, and carryover. We next introduce the clinical considerations of diagnostic accuracy, receiver operating characteristic analysis, positive and negative predictive values, and clinical utility. We finish the review by describing components of the FDA approval process for protein-based biomarkers, including classification of biomarker assays as medical devices, analytical and clinical performance requirements, and the approval process workflow. While we recognize that the road from biomarker discovery, validation, and regulatory approval to the translation into the clinical setting could be long and difficult, the reward for patients, clinicians and scientists could be rather significant.

【 授权许可】

   
2013 Füzéry et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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