Methylation Tumor Marker EP8 for Accurate Multi-Tumor Detection

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Solution Overview

Problem

Existing tumor markers based on DNA methylation have limitations in sensitivity, specificity, and lack a unified standard for clinical application, leading to misdiagnosis and inadequate detection of tumor sources and metastasis due to the heterogeneity of tumors and complexity of DNA sources in blood samples.

Innovation Solution

A methylation-based tumor marker, STAMP, targeting specific hypermethylated sites in tumor DNA, including polynucleotides with modified CpG sites, is used to develop detection agents and kits for identifying abnormal hypermethylation patterns in various tumor types.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional tumor marker detection methods (CTA, EIA, ELISA) are used, then the detection process is simple, but the detection precision and sensitivity are insufficient for early cancer diagnosis

Engineering Contradiction:
Improvedetection precisionVSAvoiddetection system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The detection system is segmented into multiple functional modules: capture antibody-coated magnetic beads for specific antigen binding, fluorescently labeled detection antibodies for signal generation, and flow cytometry equipment for high-throughput analysis. This segmentation allows each component to be optimized independently while achieving overall high precision detection.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Magnetic beads coated with capture antibodies serve as intermediaries that concentrate tumor markers from complex biological samples. The fluorescently labeled detection antibodies act as intermediaries that convert the binding event into a detectable fluorescent signal, enabling high-sensitivity detection.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If traditional tumor marker detection methods are used, then the operation is straightforward, but the detection sensitivity cannot meet early cancer diagnosis requirements

Engineering Contradiction:
Improvedetection sensitivityVSAvoidoperation complexity
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The assay system performs self-concentration through the magnetic bead-antigen binding, eliminating the need for complex sample pre-concentration steps. The fluorescent labeling provides self-amplification of the detection signal, reducing the need for sophisticated signal amplification procedures.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The detection platform uses universal magnetic bead carriers and fluorescently labeled antibodies that can be applied to detect various tumor markers (CEA, CA19-9, CA125, etc.) through the same basic protocol, maintaining ease of operation across different marker detections while achieving high sensitivity.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Measurement precision

If methylation-based modified tumor marker detection is implemented, then the detection precision and sensitivity are significantly improved, but the detection cost and technical requirements increase

Engineering Contradiction:
Improvedetection accuracyVSAvoiddetection cost
Core Design Contradiction:
Measurement precisionVSEase of manufacture

Solution Approach 1:

The invention changes the detection parameter from measuring total tumor marker concentration to measuring methylation-specific tumor marker sequences. This parameter change enables differentiation between malignant and benign conditions, significantly improving diagnostic accuracy despite the increased technical complexity.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The assay performs preliminary enrichment of methylation-specific DNA sequences using methylation-specific capture probes before detection. This preliminary action concentrates the target analyte and removes interfering substances, improving detection accuracy while reducing the need for expensive repeated testing.

Inventive Principle:
Principle #10Preliminary action

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

STAMP provides high accuracy in tumor detection and diagnosis, enabling effective clinical diagnosis, auxiliary diagnosis, and prognosis monitoring across multiple tumor types.

Implementation Method 1

coating magnetic beads with capture antibodies

Methodology Applied
Scientific EffectMagnetic separation:

Implementation Method 2

fluorescently labeled detection antibodies were added to the reaction solution, and the mixture was detected by flow cytometry

Methodology Applied
Scientific EffectFluorescence: Fluorescence

Data Source

PatentEP3964578B1Methylation-based modified tumor marker stamp-EP8 and application thereof
Publication Date: 2026.05.13 SHANGHAI EPIPROBE BIOTECH CO LTD
  • EP3964578B1 patent drawingFigure 1~3
  • EP3964578B1 patent drawingFigure 4~6
  • EP3964578B1 patent drawingFigure 7~12

AI summary

Provided are an isolated polynucleotide and a use thereof, wherein the isolated polynucleotide is the polynucleotide shown in SEQ ID NO:1 or a fragment or complementary nucleic acid thereof at a modified CpG site. Further provided are the use of the polynucleotide for preparing a tumor detection reagent or a kit, a preparation method, a reagent and a use thereof, a kit, and a method for the in-vitro detection of the methylation profile of a sample.