cfDNA Methylation Composition for Early Liver Cancer Risk Prediction
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Solution Overview
Problem
Current methods for diagnosing liver cancer are often ineffective at early stages, leading to late diagnoses and poor patient outcomes, and there is a need for a non-invasive method to predict the risk of developing liver cancer.
Innovation Solution
A composition and method utilizing methylation levels of specific CpG sites on human chromosomes 12, 17, and 19 in cell-free DNA to predict liver cancer risk, combined with alpha fetoprotein measurement, using primers and PCR-based techniques for sensitive detection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional tissue biopsy methods are used for liver cancer diagnosis, then diagnostic accuracy is improved, but patient burden and invasion risk increase
Solution Approach 1:
The patent uses cell-free DNA (cfDNA) as an intermediary mediator between the tumor and the diagnostic test. Instead of directly biopsying the tumor tissue, the test detects methylation markers in cfDNA that circulate in blood, serving as a non-invasive proxy that reflects tumor presence and characteristics without requiring tissue invasion.
Solution Approach 2:
The patent replaces the mechanical tissue biopsy process with a molecular detection method. Instead of physically removing and examining tissue samples, the system uses PCR-based methylation analysis of cfDNA sequences, substituting mechanical invasion with biochemical detection to achieve diagnosis without tissue removal.
2Reliability
If early stage liver cancer detection methods are developed, then patient survival rate is improved, but current diagnostic methods remain ineffective at early stages
Solution Approach 1:
The patent performs preliminary detection of methylation markers in cfDNA before clinical symptoms manifest or traditional diagnostics become positive. By detecting epigenetic changes in circulating DNA at early stages, the system enables intervention before the disease progresses to late stages, thereby improving survival rates through early identification.
Solution Approach 2:
The patent detects changes in DNA methylation parameters (methylation levels at specific CpG sites) as early indicators of liver cancer. These methylation parameter changes occur before structural tumor formation is detectable by conventional methods, allowing early stage detection and improving patient outcomes through timely intervention.
3Ease of operation
If non-invasive blood-based detection methods are used, then patient burden is reduced, but detection sensitivity and specificity must be sufficiently high to compensate for lack of tissue access
Solution Approach 1:
The patent segments the detection task by targeting specific methylation markers at particular CpG sites within the cfDNA sequence. Instead of analyzing entire genomes, the system focuses on specific regions (chromosome 12: 21810279-21810792, chromosome 17: 29298021-29298631, chromosome 19: 19738547-19739846) that show characteristic methylation patterns in liver cancer, thereby achieving high sensitivity with minimal invasive sampling.
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
Enhances the accuracy and sensitivity of liver cancer risk prediction, allowing for early detection and improved patient outcomes by identifying methylation markers in blood samples with high specificity and sensitivity.
Implementation Method 1
measuring a methylation level of at least one of CpG sites comprised in the 21810279th to 21810792nd sequence region of the human chromosome 12, the 29298021st to 29298631st sequence region of the human chromosome 17, or the 19738547th to 19739846th sequence region of the human chromosome 19, in a biological sample
Data Source
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AI summary
The present application relates to a composition for predicting a risk of developing liver cancer.