Cell-free DNA Methylation Detection via Fragmentation Patterns

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Solution Overview

Problem

Current methods for identifying the tissue of origin for circulating tumor DNA (ctDNA) face challenges such as the need for deep coverage bisulfite sequencing, limited reference nucleosome maps, and DNA degradation during library preparation, which hinder their clinical application.

Innovation Solution

A method involving whole-genome sequencing of cell-free DNA (cfDNA) and genomic DNA (gDNA), where alterations in fragmentation patterns are detected to identify DNA methylation patterns with single base pair resolution, allowing for the determination of the tissue of origin using a Bayesian non-homogeneous Hidden Markov Model.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If deep coverage bisulfite sequencing is used to identify DNA methylation patterns, then measurement precision is improved, but device complexity and cost increase

Engineering Contradiction:
ImproveDNA methylation pattern identification accuracyVSAvoidsequencing depth requirement
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent extracts and analyzes only the fragmentation pattern information from whole genome sequencing data, rather than performing deep coverage bisulfite sequencing. By focusing on fragment length, coverage, and distance to fragment end, the method obtains DNA methylation patterns without requiring deep sequencing coverage or bisulfite conversion procedures.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent makes whole genome sequencing data serve multiple functions: it simultaneously provides genomic information and DNA methylation pattern information through fragmentation pattern analysis. This eliminates the need for separate bisulfite sequencing experiments, reducing both complexity and cost while maintaining measurement precision.

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

2Measurement precision

If whole genome bisulfite sequencing is performed on low-input DNA samples, then measurement precision is improved, but DNA degradation increases

Engineering Contradiction:
ImproveDNA methylation detection accuracyVSAvoidDNA degradation
Core Design Contradiction:
Measurement precisionVSLoss of substance

Solution Approach 1:

The patent converts the naturally occurring fragmentation of cfDNA, which is typically seen as a limitation, into a useful signal for detecting DNA methylation patterns. By analyzing fragment length, coverage, and distance to fragment end, the method transforms DNA degradation into a source of information about methylation status without requiring additional DNA damage.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

3Adaptability or versatility

If reference nucleosome maps are expanded to cover more tissue types, then adaptability is improved, but device complexity and data processing requirements increase

Engineering Contradiction:
Improvetissue coverageVSAvoidreference data requirements
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent enables the system to generate its own reference fragmentation patterns directly from whole genome sequencing data without requiring external nucleosome maps. The method uses the sequencing data itself to establish baseline fragmentation characteristics, making the analysis self-sufficient and adaptable to any tissue type without expanding reference databases.

Inventive Principle:
Principle #25Self-service

Data Source

PatentEP3494234B1Methods for genome characterization
Publication Date: 2025.02.12 THE BROAD INST INC
  • EP3494234B1 patent drawingFigure 1A
  • EP3494234B1 patent drawingFigure 1B~1B-1
  • EP3494234B1 patent drawingFigure 1B-2

AI summary

As described below, disclosed herein are methods of analyzing DNA methylation in cell-free DNA (cfDNA) and genomic DNA (gDNA) from sequencing data.