Unified Framework Exposes Evidence Gaps in Neurological Protein Biomarkers
Researchers propose a harmonised classification system for rating the clinical validity of protein biomarkers across neurological diseases, adapted from oncology frameworks. Applying it systematically revealed that sufficient evidence for clinical use is lacking for many candidate biomarkers in neurology. The framework stratifies by clinical context of use and evidence level, helping prioritise the most promising candidates for routine adoption.
The original study
A unified classification approach rating clinical utility of protein biomarkers across neurologic diseases.
- Authors
- Bernhardt AM, Tiedt S, Teupser D, Dichgans M, Meyer B, Gempt J, et al.
- Journal
- EBioMedicine
- Type
- Journal Article, Review
- PMID
- 36745974
Original abstract
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.