title: The journey to regulation of protein-based multiplex quantitative assays.
abstract: BACKGROUND
  Clinical proteomics presents great promise in biology and medicine because of its potential for improving our understanding of diseases at the molecular level and for detecting disease-related biomarkers for diagnosis, prognosis, and prediction of therapeutic responses. To realize its full potential to improve clinical outcome for patients, proteomic studies have to be well designed, from biosample cohorts to data and statistical analyses. One key component in the biomarker development pipeline is the understanding of the regulatory science that evaluates diagnostic assay performance through rigorous analytical and clinical review criteria.
  
  
  BACKGROUND
  The National Cancer Institute's Clinical Proteomic Technologies for Cancer (CPTC) initiative has proposed an intermediate preclinical "verification" step to close the gap between protein-based biomarker discovery and clinical qualification. In collaboration with the US Food and Drug Administration (FDA), the CPTC network investigators recently published 2 mock submission review documents, first-of-their-kind educational materials that may help the scientific community interested in developing products for the clinic in understanding the likely analytical evaluation requirements for multiplex protein technology-based diagnostic tests.
  
  
  CONCLUSIONS
  Building on this momentum, the CPTC continues with this report its collaboration with the FDA, as well as its interactions with the AACC and the Centers for Medicare and Medicaid Services, to further the understanding of regulatory requirements for approving multiplex proteomic platform-based tests and analytically validating multiple analytes.
authors.affiliation: Office of Cancer Clinical Proteomics Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, USA. bojae@mail.nih.gov
authors.forename: Emily S
authors.initials: ES
authors.lastname: Boja
authors.forename: Saeed A
authors.initials: SA
authors.lastname: Jortani
authors.forename: James
authors.initials: J
authors.lastname: Ritchie
authors.forename: Andrew N
authors.initials: AN
authors.lastname: Hoofnagle
authors.forename: Živana
authors.initials: Ž
authors.lastname: Težak
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Mansfield
authors.forename: Penny
authors.initials: P
authors.lastname: Keller
authors.forename: Robert C
authors.initials: RC
authors.lastname: Rivers
authors.forename: Amir
authors.initials: A
authors.lastname: Rahbar
authors.forename: N Leigh
authors.initials: NL
authors.lastname: Anderson
authors.forename: Pothur
authors.initials: P
authors.lastname: Srinivas
authors.forename: Henry
authors.initials: H
authors.lastname: Rodriguez
mesh_terms: D015415:Biomarkers / Q000032:analysis*; D011506:Proteins / Q000032:analysis*; D015203:Reproducibility of Results
chemical_list: D015415:Biomarkers; D011506:Proteins