Volume 566 of the series Methods in Molecular Biology pp 303-313


Translation of Neurological Biomarkers to Clinically Relevant Platforms

  • Ronald L. HayesAffiliated withCenter of Innovative Research, Clinical Department, Banyan Biomarkers Inc. Email author 
  • , Gillian RobinsonAffiliated withClinical Department, Banyan Biomarkers Inc.
  • , Uwe MullerAffiliated withClinical Department, Banyan Biomarkers Inc.
  • , Kevin K. W. WangAffiliated withCenter for Neuroproteomics and Biomarkers Research, Department of Psychiatry, McKnight Brain Institute of the University of Florida

* Final gross prices may vary according to local VAT.

Get Access


Like proteomics more generally, neuroproteomics has recently been linked to the discovery of biochemical markers of central nervous system (CNS) injury and disease. Although neuroproteomics has enjoyed considerable success in discovery of candidate biomarkers, there are a number of challenges facing investigators interested in developing clinically useful platforms to assess biomarkers for damage to the CNS. These challenges include intrinsic physiological complications such as the blood–brain barrier. Effective translation of biomarkers to clinical practice also requires development of entirely novel pathways and product development strategies. Drawing from lessons learned from applications of biomarkers to traumatic brain injury, this study outlines major elements of such a pathway. As with other indications, biomarkers can have three major areas of application: (1) drug development; (2) diagnosis and prognosis; (3) patient management. Translation of CNS biomarkers to practical clinical platforms raises a number of integrated elements. Biomarker discovery and initial selection needs to be integrated at the earliest stages with components that will allow systematic prioritization and triage of biomarker candidates. A number of important criteria need to be considered in selecting clinical biomarker candidates. Development of proof of concept assays and their optimization and validation represent an often overlooked feature of biomarker translational research. Initial assay optimization should confirm that assays can detect biomarkers in relevant clinical samples. Since access to human clinical samples is critical to identification of biomarkers relevant to injury and disease as well as for assay development, design of human clinical validation studies is an important component of translational biomarker research platforms. Although these clinical studies share much in common with clinical trials for assessment of drug therapeutic efficacy, there are a number of considerations unique to these efforts. Finally, platform selection and potential assay commercialization need to be considered. Decisions regarding whether or not to seek FDA approval also significantly influence translational research structures.

Key words

Biomarkers Brain injury Translational research Assay development Clinical trials