Plasma cfDNA Methylation Panel for Early HCC Detection

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Solution Overview

Problem

Current early screening techniques for hepatocellular carcinoma, such as alpha-fetoprotein detection and ultrasound, have low sensitivity, and the complexity and high cost of next-generation sequencing limit the clinical application of DNA methylation markers for liver tumor detection.

Innovation Solution

A kit and method using a DNA methylation marker combination, including markers like IKZF1, Septin9, IRF4, DAB2IP, TSPYL5, CHFR, BEND4, GRASP, and GPAM, for liver tumor detection, employing PCR amplification and methylation microarray techniques, and a machine learning model to analyze plasma samples for early screening and recurrence monitoring.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If next-generation sequencing technology is used for DNA methylation marker detection, then detection sensitivity and accuracy are improved, but device complexity and cost increase

Engineering Contradiction:

Improvedetection sensitivityVSAvoiddetection complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent extracts and focuses on specific methylation marker genes (IKZF1, Septin9, IRF4, DAB2IP, TSPYL5, CHFR, BEND4, GRASP, GPAM, and BDH1) from the entire genome, detecting only these targeted regions rather than performing whole-genome sequencing. This extraction approach maintains high detection sensitivity while significantly reducing complexity and cost.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent uses PCR amplification to create multiple copies of the target methylation marker regions before detection. This copying process amplifies the signal from the rare methylated DNA fragments in early-stage cancer, enabling sensitive detection without requiring complex sequencing infrastructure.

Inventive Principle:

Principle #26Copying

2Measurement precision

If next-generation sequencing technology is used for DNA methylation marker detection, then detection sensitivity is improved, but detection cost increases

Engineering Contradiction:

Improvedetection sensitivityVSAvoiddetection cost

Core Design Contradiction:

Measurement precisionVSQuantity of substance

Solution Approach 1:

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent employs cost-effective PCR-based detection methods and simple microarray technology instead of expensive sequencing platforms. These simpler, more affordable techniques enable widespread clinical application for early liver cancer screening while maintaining adequate detection sensitivity.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

3Adaptability or versatility

If traditional screening methods (AFP detection and ultrasound) are used, then clinical applicability is maintained, but detection sensitivity is low

Engineering Contradiction:

Improveclinical applicabilityVSAvoiddetection sensitivity

Core Design Contradiction:

Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The patent develops a detection system that works universally across different clinical settings by using standardized blood sampling and simplified laboratory procedures. The method can be applied to various patient populations and integrated into existing clinical workflows, maintaining broad applicability while achieving superior sensitivity through methylation marker detection.

Inventive Principle:

Principle #6Universality (Multi-functionality)

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 provides high sensitivity and specificity for early screening and recurrence monitoring of hepatocellular carcinoma, improving detection accuracy and reducing clinical costs.

Implementation Method 1

abnormal DNA methylation in blood has been widely recognized as a non-invasive marker for cancer detection. It has been found in various cancers that alterations in DNA methylation lead to abnormal gene expression

Methodology Applied

Scientific EffectDNA methylation:

Implementation Method 2

The rapid development of technologies for selective specific enrichment and amplification of methylated sequences has facilitated highly sensitive detection

Methodology Applied

Scientific EffectPCR amplification:

Data Source

PatentEP4678769A1Use of plasma cell-free DNA methylation marker in liver tumor detection

Publication Date: 2026.01.14 SINGLERA HEALTH TECH SHANGHAI LTD

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AI summary

A use of a plasma cell-free DNA methylation marker in liver tumor detection is provided. Specifically, a kit for liver tumor detection is provided. The kit comprises a reagent for detecting the methylation level of a DNA methylation marker combination, wherein the DNA methylation marker combination is one or more selected from IKZF1, Septin9, IRF4, DAB2IP, TSPYL5, CHFR, BEND4, GRASP, GPAM, and BDH1. A model constructed by means of the methylation detection result of the marker combination can be used for early screening and recurrence monitoring of HCC.