Blood-based traumatic brain injury biomarkers: Clinical utilities and regulatory pathways in the United States, Europe and Canad

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Blood-based traumatic brain injury biomarkers : Clinical utilities and regulatory pathways in the United States, Europe and Canad

Wang, Kevin K. (author): Program for Neurotrauma, Neuroprotoemics & Biomarker Research, Department of Emergency Medicine, University of Florida College of Medicine, Gainesville, Florida, USA; Brain Rehabilitation Research Center (BRRC), Malcom Randall Veterans Affairs Medical Center, Gainesville, Florida, USA

Munoz Pareja, Jennifer C. (author): Department of Pediatric Critical Care, University of Miami Miller School of Medicine, Miami, Florida, USA

Mondello, Stefania (author): Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy

Diaz-Arrastia, Ramon (author): Department of Neurology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA

Wellington, Cheryl (author): Djavad Mowafaghian Centre for Brain Health, University of British Columbia, Canada

Kenney, Kimbra (author): Department of Neurology, Uniformed Service University, Bethesda, Maryland, USA

Puccio, Ava M. (author): Department of Neurological Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA

Hutchison, Jamie (author): The Hospital for Sick Children, Department of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada

McKinnon, Nicole (author): The Hospital for Sick Children, Department of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada

Okonkwo, David O. (author): Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA

Yang, Zhihui (author): Program for Neurotrauma, Neuroprotoemics & Biomarker Research, Department of Emergency Medicine, University of Florida College of Medicine, Gainesville, Florida, USA; Brain Rehabilitation Research Center (BRRC), Malcom Randall Veterans Affairs Medical Center, Gainesville, Florida, USA

Kobeissy, Firas (author): Program for Neurotrauma, Neuroprotoemics & Biomarker Research, Department of Emergency Medicine, University of Florida College of Medicine, Gainesville, Florida, USA; Brain Rehabilitation Research Center (BRRC), Malcom Randall Veterans Affairs Medical Center, Gainesville, Florida, USA

Tyndall, J. Adrian (author): Program for Neurotrauma, Neuroprotoemics & Biomarker Research, Department of Emergency Medicine, University of Florida College of Medicine, Gainesville, Florida, USA

Büki, Andras, 1966- (author)

Czeiter, Endre (author): Department of Neurosurgery, Pecs University, Pecs, Hungary

Pareja Zabala, Maria C. (author): Fundación Universitaria Sanitas, Bogota, Colombia

Gandham, Nithya (author): Program for Neurotrauma, Neuroprotoemics & Biomarker Research, Department of Emergency Medicine, University of Florida College of Medicine, Gainesville, Florida, USA

Berman, Rebecca (author): National Institute of Neurological Disorders and Stroke, National Institute of Health, Bethesda, MD, USA

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(creator_code:org_t)

2021-11-29
2021
English.
In: Expert Review of Molecular Diagnostics. - : Expert Reviews Ltd.. - 1473-7159 .- 1744-8352. ; 21:12, s. 1303-1321

Related links:: https://urn.kb.se/re...; show more...; https://doi.org/10.1...; show less...

Research review (peer-reviewed)

Abstract Subject headings

Introduction: Traumatic brain injury (TBI) is a major global health issue, resulting in debilitating consequences to families, communities, and health-care systems. Prior research has found that biomarkers aid in the pathophysiological characterization and diagnosis of TBI. Significantly, the FDA has recently cleared both a bench-top assay and a rapid point-of-care assays of tandem biomarker (UCH-L1/GFAP)-based blood test to aid in the diagnosis mTBI patients. With the global necessity of TBI biomarkers research, several major consortium multicenter observational studies with biosample collection and biomarker analysis have been created in the USA, Europe, and Canada. As each geographical region regulates its data and findings, the International Initiative for Traumatic Brain Injury Research (InTBIR) was formed to facilitate data integration and dissemination across these consortia.Areas covered: This paper covers heavily investigated TBI biomarkers and emerging non-protein markers. Finally, we analyze the regulatory pathways for converting promising TBI biomarkers into approved in-vitro diagnostic tests in the United States, European Union, and Canada.Expert opinion: TBI biomarker research has significantly advanced in the last decade. The recent approval of an iSTAT point of care test to detect mild TBI has paved the way for future biomarker clearance and appropriate clinical use across the globe.

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MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Neurology

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By the university: Örebro University

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Blood-based traumatic brain injury biomarkers : Clinical utilities and regulatory pathways in the United States, Europe and Canad

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