Serum N-Glycan Reagent for Non-Invasive Prostate Cancer Detection

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Solution Overview

Problem

Current methods for detecting prostate cancer, such as PSA detection and biopsy, are not sensitive enough for early-stage diagnosis and are invasive, making it difficult to detect the disease in its early stages, and existing analytical techniques for oligosaccharides are costly, complex, or not suitable for clinical use.

Innovation Solution

A prostate cancer monitoring reagent using a combination of reagents (A, B, C, D) for fluorescence labeling and capillary electrophoresis (G-Test) to analyze N-glycan profiles in serum samples, enabling non-invasive and accurate detection through the ratio of NA2/NA2F.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If PSA detection is used for prostate cancer diagnosis, then the diagnosis can be performed non-invasively, but the sensitivity for early-stage detection is insufficient

Engineering Contradiction:
Improvedetection sensitivityVSAvoiddetection method complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention segments the complex oligosaccharide analysis into distinct functional reagents: Reagent A (ammonium bicarbonate-SDS solution) for sample preparation, Reagent B (enzymatic reagent) for oligosaccharide release and labeling, and Reagent C (fluorescence labeling reagent) for detection. This segmentation allows each component to be optimized independently while maintaining overall system simplicity and high detection sensitivity for early-stage prostate cancer.

Inventive Principle:
Principle #1Segmentation

2Measurement precision

If biopsy is performed for prostate cancer diagnosis, then the diagnostic accuracy is improved, but the procedure becomes more traumatic and invasive

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidpatient trauma
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The invention uses serum oligosaccharide profiles as an intermediary marker that reflects prostate cancer presence without requiring direct tissue sampling. The reagents detect cancer-specific oligosaccharide patterns in blood serum, providing high diagnostic accuracy while completely avoiding the trauma of biopsy procedures.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Measurement precision

If HPLC is used for oligosaccharide analysis, then the resolution and detection speed are improved, but the equipment cost and operational complexity increase

Engineering Contradiction:
Improveoligosaccharide analysis resolutionVSAvoidequipment and operation complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The invention replaces expensive, complex HPLC equipment with a disposable reagent-based system. The reagents contain pre-formulated chemicals and enzymes that perform oligosaccharide analysis through simple mixing and fluorescence detection, eliminating the need for costly HPLC instruments while maintaining high resolution through the specific chemical composition of the reagents.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

4Measurement precision

If Mass Spectrometry is used for oligosaccharide analysis, then the sensitivity and structural information are improved, but the equipment cost and operational complexity increase

Engineering Contradiction:
Improveoligosaccharide detection sensitivityVSAvoidoperation simplicity
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The reagents are designed to be self-contained systems where Reagent A, B, and C automatically perform sample preparation, oligosaccharide release, and fluorescence labeling in sequence. The reagents themselves provide the necessary enzymatic and chemical functions, eliminating the need for complex mass spectrometry instrumentation and highly trained operators while achieving comparable or superior sensitivity for prostate cancer detection.

Inventive Principle:
Principle #25Self-service

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 a high sensitivity and accuracy of 97.2% for prostate cancer detection, allowing routine, non-invasive monitoring of the disease progression, suitable for clinical use.

Implementation Method 1

Reagent C: It is prepared from 8-Aminopyrene-1,3,6-trisulfonic acid trisodium salt dissolved in DMSO, the concentration is 0.01 mM~1 M

Methodology Applied
Scientific EffectFluorescence labeling: Fluorescence

Implementation Method 2

G-Test (Glycan-Test) is a DNA analyzer-based capillary microelectrophoresis technology (DSA-FACE)

Methodology Applied
Scientific EffectCapillary electrophoresis: Capillary Electrophoresis

Implementation Method 3

Reagent B: It is prepared by mixing 0.01-10 U/10 μL glycoamidase and 0.01-10 U/10 μL Sialidase

Methodology Applied
Scientific EffectEnzymatic hydrolysis: Enzyme

Data Source

PatentEP4403641B1Prostate cancer detection reagent and use thereof in prostate cancer detection
Publication Date: 2025.12.10 JIANGSU XIANSIDA BIOTECH CO LTD
  • EP4403641B1 patent drawingFigure 1~3

AI summary

The invention provides a prostate cancer detection reagent and a preparation method thereof. The detection reagent is prepared by mixing the following reagents, reagent A is prepared by adding SDS with a mass concentration of 0.5-5% into ammonium bicarbonate solution with a concentration of 10 mM; Reagent B was prepared by mixing 0.01-10 U/10 µL glycoamidase and 0.01-10 U/10 µL Sialidase, and the pH value of the mixed solution was 4-9. Reagent C: Prepared from 8-Aminopyrene-1,3,6-trisulfonic acid trisodium salt dissolved in DMSO, the concentration is 0.01 mM~1 M; Reagent D: Stopping solution. The invention determines the N-glycan profile in serum by the detection reagent, quantifies the peak value for statistical analysis, and provides a method for establishing a model of the N-glycan profile in serum of prostate cancer to detect prostate cancer.