Serum Biomarker Panel for CKD Early Detection

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Solution Overview

Problem

Current diagnostic methods for kidney disease, particularly chronic kidney disease (CKD), lack sensitivity and specificity for early detection and monitoring, with GFR measurement being insufficient for early detection and urinary protein not specific for kidney disease progression.

Innovation Solution

Identification of altered biomarker levels in serum, including C3a desArg, IL-8, MIP 1α, ADPN, CD26, Creatinine, CRP, CYSC, D-dimer, EGF, ESEL, FABP1, GMCSF, ICAM1, IFNγ, IL10, IL15, IL1α, IL1β, IL2, IL4, IL5, IL6, LSEL, MCP1, MMP9, NGAL, NSE, PSEL, sIL2α, sIL6R, STNFR1, STNFR2, TNFα, VEGF, and VCAM1, for diagnosing and staging CKD.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If GFR measurement is used for diagnosis, then kidney function can be assessed, but sensitivity for early detection is insufficient

Engineering Contradiction:

Improveearly detection sensitivityVSAvoiddiagnostic accuracy

Core Design Contradiction:

Measurement precisionVSReliability

Solution Approach 1:

The patent changes the diagnostic parameters from traditional GFR measurement to a panel of biomarkers including C3a desArg, IL-8, MIP 1α, ADPN, CD26, Creatinine, CRP, CYSC, D-dimer, EGF, ESEL, FABP1, GMCSF, ICAM1, IFNγ, IL10, IL15, IL1α, IL1β, IL2, IL4, IL5, IL6, LSEL, MCP1, MMP9, NGAL, NSE, PSEL, sIL2α, sIL6R, STNFR1, STNFR2, TNFα, VEGF and VCAM1. This parameter change enables early detection of kidney disease stages 1-3 with improved sensitivity and specificity.

Inventive Principle:

Principle #35Parameter changes

2Measurement precision

If urinary protein measurement is used for diagnosis, then kidney damage can be detected, but specificity for kidney disease progression is insufficient

Engineering Contradiction:

Improvespecificity for disease progressionVSAvoiddiagnostic accuracy

Core Design Contradiction:

Measurement precisionVSReliability

Solution Approach 1:

The patent replaces urinary protein measurement with serum biomarker measurements. The biomarker panel includes inflammatory markers (IL-8, TNFα, MCP1), complement components (C3a desArg), adhesion molecules (ICAM1, VCAM1, ESEL), and other kidney-specific markers (NGAL, FABP1, ADPN). This parameter change provides both sensitivity for early detection and specificity for disease progression.

Inventive Principle:

Principle #35Parameter changes

3Productivity

If traditional diagnostic methods are used, then current standards can be maintained, but early stage CKD detection capability is limited

Engineering Contradiction:

Improveearly stage detection capabilityVSAvoiddiagnostic accuracy

Core Design Contradiction:

ProductivityVSMeasurement precision

Solution Approach 1:

The patent segments the diagnosis into multiple biomarker measurements rather than relying on a single test. The biomarker panel is divided into categories including inflammatory markers, complement components, adhesion molecules, and kidney-specific markers. This segmentation allows for comprehensive assessment of early kidney disease stages 1-3 with superior diagnostic accuracy.

Inventive Principle:

Principle #1Segmentation

Data Source

PatentUS10545157B2Kidney disease biomarker

Publication Date: 2020.01.28 NORTHERN BANK LTD

AI summary

The disclosure provides methods and solid states devices for detecting and staging chronic kidney disease in a patient, where the levels of biomarkers in a sample obtained from a patient are elevated or reduced compared to the levels in a sample obtained from healthy subject. In addition, the disclosure provides the use of methods and solid state devices for measurement of specific biological markers for determining the efficacy of a treatment for chronic kidney disease and for determining a drug treatment protocol for a subject suffering from chronic kidney disease.