Method for Determining Indicators for Disease Diagnosis

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This patent describes a method and kit for the qualitative and/or quantitative detection of specific disease indicators, particularly aggregates of misfolded proteins such as tau and α-synuclein, in body fluids or tissues. The method uses capture molecules (such as antibodies) immobilized on a substrate to selectively bind these protein aggregates, and then uses at least two different labeled probes for their detection with spatially resolved signal analysis (e.g., sFIDA, a fluorescence-based method). The approach can distinguish and analyze multiple types of protein aggregates simultaneously or in a single sample, enhancing differential diagnosis of diseases such as tauopathies, Parkinson's disease, and Alzheimer's dementia.

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• Early and accurate clinical diagnosis of neurodegenerative diseases such as Parkinson's disease, Alzheimer's disease, and other tauopathies by detecting characteristic protein aggregates in body fluids (e.g., blood, CSF).
• Differential diagnosis between diseases with overlapping symptoms by simultaneous detection of multiple protein aggregate types or mixed aggregates.
• Monitoring disease progression or response to therapies in neurodegenerative conditions by quantitatively measuring biomarker aggregates.
• Research tool for studying the role of protein aggregation in various diseases, including mental disorders (e.g., schizophrenia), amyloidoses, or diabetes type 2.
• Screening of at-risk populations for pre-symptomatic identification of neurodegenerative diseases.
• Standardization and comparison of diagnostic test results across different laboratories using defined aggregation standards or kits.

BenefitsContent extracted from patent full text and abstract with AI.

• Enables minimally invasive, highly specific, and sensitive detection of disease biomarkers in easily accessible human samples (like blood or CSF).
• Allows simultaneous or parallel analysis of multiple protein aggregate types, improving differential diagnosis and reducing false positives/negatives.
• Can be used for early detection, even in pre-symptomatic stages, supporting preventive interventions and therapy optimization.
• Reduces need for more invasive diagnostic procedures such as biopsies.
• Objective and quantifiable test results facilitate standardization, monitoring, and cross-laboratory comparability.
• Applicable for routine clinical diagnostics due to its compatibility with standard laboratory instruments and protocols.
• Supports personalized medicine by enabling disease stratification and tailored treatment monitoring.

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Patent Abstract

The invention relates to a method for detecting indicators for detecting diseases (disease indicators), misfolded proteins in the aggregates thereof playing a roll. The invention also relates to a method for selectivity quantifying and/or characterizing said disease indicators.