Over the last two decades, a number of candidate TBI biomarkers and biomarker pathways have been identified. Detection techniques have improved significantly and the field is poised to establish systematic guidelines for qualification of biomarkers. The strength of biomarkers as diagnostic or prognostic tools in TBI is their straightforward time course. Once a biomarker has been qualified, assays can be analyzed uniformly across a context of use. Biomarkers are by their nature, more prognostic for severe TBI; the challenge is to find diagnostic biomarkers for mild and moderate TBI.
The Blood-Based Biomarker Expert Working Group has established the following goals:
- Establish biomarkers as diagnostic or management tools for TBI patients. As a point of care device, a biomarker must have high sensitivity to disease state while minimizing noise.
- Establish biomarkers as qualified tools and/or entry criteria for clinical trials. There is a HUGE need for this, and it does not require a point-of-care device. We can integrate preclinical models to narrow down the list of biomarkers here.
Lead: Ramon Diaz-Arrastia, MD PhD | Dr. Diaz-Arrastia is a neurologist with more than 20 years of experience in clinical practice and research in TBI. He has been PI of several NIH and industry sponsored clinical trials concerning TBI, Alzheimer’s disease, epilepsy, and HIV-associated dementia. He is currently Professor of Neurology at the Uniformed Services University, as well as Director of Clinical Research at the Center for Neuroscience and Regenerative Medicine (CNRM). Dr. Diaz-Arrastia is the co-PI of the recently created Chronic Effects of Neurotrauma Consortium (CENC), as well as a member of the Executive Committees of TRACK-TBI and TED.
Co-Lead: Kevin Wang, PhD | Dr. Wang is Executive Director, Center for Neuroproteomics & Biomarkers Research and Chief of Translational Research at the McKnight Brain Institute of the University of Florida. Dr. Wang has contributed significantly to the discovery and development of two acute TBI protein biomarkers (UCH-L1 and GFAP-BDP) and their diagnostic utility characterization in several animal and human TBI spectrum studies. This TBI biomarker tandem is now in a pivotal study for FDA approval as a new first-in-class in vitro diagnostic (IVD) test for mild-moderate TBI (ALERT Trial). He provides expert scientific advice for validation of clinically relevant blood-based biomarkers acceptable for regulatory review of devices and drugs aimed at the diagnosis and treatment of mild and moderate TBI.