Blood Biomarker Panel for Neurological Disease Screening
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Solution Overview
Problem
Current methods for detecting and discriminating between neurological diseases in primary care settings lack accuracy and efficiency, particularly in identifying biomarkers for Alzheimer's Disease, Parkinson's Disease, and Dementia with Lewy Bodies, due to low sensitivity and specificity in blood-based screenings.
Innovation Solution
A method involving the measurement of specific biomarkers such as IL7, TNFα, IL5, IL6, CRP, IL10, TNC, ICAM1, FVII, TNFR1, A2M, TARC, eotaxin3, VCAM1, TPO, FABP, IL18, B2M, SAA, PPY, DJ1, and α-synuclein in serum or plasma samples, combined with neurocognitive screening tests, using techniques like immunoassays or enzymatic activity assays, to achieve high accuracy in diagnosing and differentiating between these neurological diseases.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If blood-based screening methods are used in primary care settings, then accessibility and ease of operation are improved, but measurement precision and reliability are insufficient
Solution Approach 1:
The patent combines multiple biomarker measurements (NFL, Aβ42, tau, α-synuclein) into a single blood-based screening panel that can be performed in primary care settings. This merging of multiple diagnostic indicators into one accessible test allows primary care providers to conduct comprehensive neurological disease screening without requiring specialized facilities, thus improving ease of operation while maintaining measurement precision through the use of validated biomarkers.
Solution Approach 2:
The screening method is designed to detect multiple neurological diseases (Alzheimer's disease, Parkinson's disease, Lewy body dementia) using a single blood-based approach. This multi-functional capability allows the same test to serve universal screening purposes across different disease types, making the screening accessible in primary care settings while maintaining the precision needed for accurate disease differentiation through pattern recognition of biomarker profiles.
2Measurement precision
If multiple biomarkers are measured to improve diagnostic accuracy, then measurement precision is improved, but device complexity and cost increase
Solution Approach 1:
The patent segments the diagnostic process into two distinct stages: (1) a simple blood-based screening stage measuring multiple biomarkers simultaneously, and (2) a confirmatory stage using more complex imaging or specialized tests only for those who screen positive. This segmentation allows high measurement precision through multiple biomarker measurement while controlling device complexity by reserving complex methodologies for targeted confirmatory cases rather than universal application.
Solution Approach 2:
The patent applies different levels of testing complexity to different patient groups based on their risk profiles and screening results. High-precision multiple biomarker measurement is applied locally to the screening phase where it provides maximum value, while simpler methods are used for low-risk individuals, and confirmatory complex testing is applied only to screen-positive cases. This local quality approach optimizes diagnostic accuracy while managing system complexity.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The method achieves high sensitivity and specificity, with accuracy rates of up to 100% for mild AD and 97% for very early AD, and effectively discriminates between neurodegenerative diseases, enabling precise referrals to specialists and reducing the need for costly confirmatory diagnostics.
Implementation Method 1
measuring a level of four or more biomarkers selected from IL7, TNFα, IL5, IL6, CRP, IL10, TNC, ICAM1, FVII, I309, TNFR1, A2M, TARC, eotaxin3, VCAM1, TPO, FABP, IL18, B2M, SAA, PPY, DJ1, and α-synuclein in a sample separated from a human subject with a nucleic acid, an immunoassay or an enzymatic activity assay
Implementation Method 2
measuring a level of four or more biomarkers selected from IL7, TNFα, IL5, IL6, CRP, IL10, TNC, ICAM1, FVII, I309, TNFR1, A2M, TARC, eotaxin3, VCAM1, TPO, FABP, IL18, B2M, SAA, PPY, DJ1, and α-synuclein in a sample separated from a human subject with a nucleic acid, an immunoassay or an enzymatic activity assay
Data Source
AI summary
The present invention includes methods and kits for measuring a level of four or more biomarkers selected measuring a level of four or more biomarkers selected from ILL IL7, TNFα, IL5, IL6, CRP, IL10, TNC, ICAM1, FVII, I309, TNFR1, A2M, TARC, adiponectin, MIP1, eotaxin3, sVCAM1, TPO, FABP, IL18, B2M, SAA, PPY, DJ1, and α-synuclein, Aβ40, Aβ42, tau, α-synuclein, and NfL in a sample separated from a human subject in the primary care setting with neurological disease with a nucleic acid, an immunoassay or an enzymatic activity assay.