DNA Methylation Normalization Using Endogenous Controls

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Solution Overview

Problem

Current methods for determining DNA methylation levels in specific genomic regions rely on external standards and repetitive sequences, which are not precise and do not account for differential methylation patterns, limiting their diagnostic potential for tumor detection.

Innovation Solution

A method that quantitatively determines the presence of specific DNA segments and differentially methylated CpG dinucleotides within these segments, excluding repetitive sequences, to normalize DNA methylation levels, enabling the detection of hyper- and hypomethylation patterns in gene sections for tumor diagnosis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If external standards and repetitive sequences are used for methylation analysis, then the analysis can be performed, but the precision and accuracy of methylation level determination deteriorates

Engineering Contradiction:
Improvemethylation level determination precisionVSAvoiddiagnostic potential
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent extracts and eliminates the use of external standards and repetitive sequences from the methylation analysis process. Instead, it focuses on analyzing endogenous control regions within the target DNA itself, removing the sources of imprecision and improving both measurement precision and diagnostic reliability.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The method enables the DNA sample to serve itself by using endogenous control regions within the target DNA as internal references for normalization. This self-contained approach eliminates dependency on external standards and improves the reliability of methylation level determination.

Inventive Principle:
Principle #25Self-service

2Adaptability or versatility

If transposon sequences are used for normalization, then genome-wide methylation changes can be detected, but the ability to detect hypermethylated regions deteriorates

Engineering Contradiction:
Improvegenome-wide methylation detectionVSAvoidhypermethylation detection accuracy
Core Design Contradiction:
Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

Instead of using transposon sequences to normalize methylation data, the patent inverts the approach by using endogenous control regions within the target DNA itself as the normalization reference. This reversal enables accurate detection of both hypomethylated and hypermethylated regions while maintaining genome-wide applicability.

Inventive Principle:
Principle #13The other way round (Inversion)

Solution Approach 2:

The patent introduces endogenous control regions as an intermediary element that mediates between the target DNA and the normalization process. These control regions serve as internal references that accurately reflect the methylation status of the target regions, enabling precise detection of differential methylation patterns.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Quantity of substance

If repetitive DNA segments are included in analysis, then more genomic regions can be examined, but the accuracy of specific gene segment methylation determination deteriorates

Engineering Contradiction:
Improvenumber of genomic regions examinedVSAvoidspecific gene segment methylation accuracy
Core Design Contradiction:
Quantity of substanceVSMeasurement precision

Solution Approach 1:

The patent segments the DNA analysis into specific gene regions of interest with their associated endogenous control regions, rather than analyzing repetitive DNA segments. This segmentation allows examination of specific functional genes while using their internal control regions for accurate normalization, maintaining both quantity and precision.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The method applies local quality control by using endogenous control regions specific to each target gene segment being analyzed. Each gene region has its own internal reference that accounts for local variations in DNA extraction, amplification, and processing, thereby maintaining high precision for specific gene segment methylation determination.

Inventive Principle:
Principle #3Local quality

Data Source

PatentEP3981885B1Method for determining the degree of DNA methylation
Publication Date: 2023.07.12 SANTOURLIDIS SIMEON
  • EP3981885B1 patent drawingFigure 1~1B
  • EP3981885B1 patent drawingFigure 2~2B
  • EP3981885B1 patent drawingFigure 3a

AI summary

Method for determining the normalized degree of DNA methylation of one or more DNA segments, excluding repetitive sequences, in a sample of genomic DNA for the diagnosis of a bladder tumor.