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Bernhardt, A.M.* ; Tiedt, S.* ; Teupser, D.* ; Dichgans, M.* ; Meyer, B.* ; Gempt, J.* ; Kuhn, P.H.* ; Simons, M.* ; Palleis, C.* ; Weidinger, E.* ; Nübling, G.* ; Holdt, L.* ; Hönikl, L.* ; Gasperi, C.* ; Giesbertz, P.* ; Müller, S.A.* ; Breimann, S.* ; Lichtenthaler, S.F.* ; Kuster, B.* ; Mann, M.* ; Imhof, A.* ; Barth, T.* ; Hauck, S.M. ; Zetterberg, H.* ; Otto, M.* ; Weichert, W.* ; Hemmer, B.* ; Levin, J.*

A unified classification approach rating clinical utility of protein biomarkers across neurologic diseases.

EBioMedicine 89:104456 (2023)
Publ. Version/Full Text DOI PMC
Open Access Gold
Creative Commons Lizenzvertrag
A major evolution from purely clinical diagnoses to biomarker supported clinical diagnosing has been occurring over the past years in neurology. High-throughput methods, such as next-generation sequencing and mass spectrometry-based proteomics along with improved neuroimaging methods, are accelerating this development. This calls for a consensus framework that is broadly applicable and provides a spot-on overview of the clinical validity of novel biomarkers. We propose a harmonized terminology and a uniform concept that stratifies biomarkers according to clinical context of use and evidence levels, adapted from existing frameworks in oncology with a strong focus on (epi)genetic markers and treatment context. We demonstrate that this framework allows for a consistent assessment of clinical validity across disease entities and that sufficient evidence for many clinical applications of protein biomarkers is lacking. Our framework may help to identify promising biomarker candidates and classify their applications by clinical context, aiming for routine clinical use of (protein) biomarkers in neurology.
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Publication type Article: Journal article
Document type Review
Keywords Analytical Validity ; Biomarker ; Clinical Utility ; Neurology ; Protein ; Proteomics; Fibrillary Acidic Protein; Alzheimers-disease; Cerebrospinal-fluid; Multiple-sclerosis; Alpha-synuclein; Neurofilament Light; Serum Biomarkers; Diagnosis; Csf; Marker
Language english
Publication Year 2023
HGF-reported in Year 2023
ISSN (print) / ISBN 2352-3964
e-ISSN 2352-3964
Journal EBioMedicine
Quellenangaben Volume: 89, Issue: , Pages: , Article Number: 104456 Supplement: ,
Publisher Elsevier
Publishing Place Amsterdam [u.a.]
Reviewing status Peer reviewed
Institute(s) CF Metabolomics & Proteomics (CF-MPC)
POF-Topic(s) 30203 - Molecular Targets and Therapies
Research field(s) Enabling and Novel Technologies
PSP Element(s) G-505700-001
Grants Deutsche Forschungsgemeinschaft (DFG, German Research Foundation)
Munich Cluster for Systems Neurology
BMBF
DOI 10.1016/j.ebiom.2023.104456
WOS ID 000968658100001
Scopus ID 85147819736
PubMed ID 36745974
Erfassungsdatum 2023-02-18
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