title: Regulatory perspective on translating proteomic biomarkers to clinical diagnostics.
abstract: Issues associated with the translation of complex proteomic biomarkers from discovery to clinical diagnostics have been widely discussed among academic researchers, government agencies, as well as assay and instrumentation manufacturers. Here, we provide an overview of the regulatory framework and type of information that is typically required in order to evaluate in vitro diagnostic tests regulated by the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) at the US Food and Drug Administration (FDA), with the focus on some of the issues specific to protein-based complex tests. Technological points pertaining to mass spectrometry platforms and assessment of potential concerns important for assurance of safety and effectiveness of this type of assays when introduced into clinical diagnostic use, as well as general approaches for evaluating the performance of these devices, are discussed.
authors.affiliation: Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, United States. Jinong.li@fda.hhs.gov
authors.forename: Jinong
authors.initials: J
authors.lastname: Li
authors.forename: Kellie B
authors.initials: KB
authors.lastname: Kelm
authors.forename: Zivana
authors.initials: Z
authors.lastname: Tezak
mesh_terms: D000818:Animals; D019411:Clinical Laboratory Techniques / Q000295:instrumentation / Q000379:methods / Q000592:standards; D006801:Humans; D013058:Mass Spectrometry / Q000295:instrumentation / Q000379:methods / Q000639:trends; D040901:Proteomics / Q000295:instrumentation / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration