UMI Adaptor Tagging for Rare cfDNA Copy Number Detection

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Existing methods for genetic analysis, particularly in detecting rare copy number changes in biological samples, lack the sensitivity to identify mutations at very minor allele frequencies, especially in cell-free DNA (cfDNA) samples.

Innovation Solution

The use of adaptors with unique molecular identifiers (UMIs) and sample tags to generate genomic DNA libraries, allowing for high-resolution detection of genetic changes by forming complexes with capture probes, followed by primer extension, amplification, and sequencing to identify genetic variations such as copy number changes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional SNP genotyping methods are used, then allele frequencies can be detected at common levels (~100%, 50%, or 0%), but the methods lack sensitivity to detect rare mutations at very minor allele frequencies in cfDNA samples

Engineering Contradiction:
Improvedetection sensitivity for minor allele frequencyVSAvoidamount of DNA from cfDNA sample
Core Design Contradiction:
Measurement precisionVSQuantity of substance

Solution Approach 1:

The adaptor is segmented into distinct functional regions: a UMI region for molecular identification, a sample index region for sample identification, and an amplification region. This segmentation allows each region to perform its specific function optimally, with the UMI region enabling precise tracking of individual DNA molecules to detect rare mutations even in small cfDNA samples

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The UMI is incorporated into the adaptor during the initial library preparation step, before amplification and sequencing. This preliminary tagging of each DNA molecule with a unique identifier allows for accurate reconstruction of the original DNA population and detection of rare mutations that would otherwise be lost in the noise of amplification and sequencing variability

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

The method achieves sensitive detection of copy number variations in a small fraction of total DNA, enabling accurate identification of genetic changes indicative of disease states, even at minor allele frequencies.

Implementation Method 1

adaptors with unique molecular identifiers (UMIs) and sample tags to generate genomic DNA libraries, allowing for high-resolution detection of genetic changes by forming complexes with capture probes

Methodology Applied
Scientific EffectHybridization:

Implementation Method 2

contacting the genomic DNA library with a plurality of capture probes that specifically bind to a DNA target region, thereby forming complexes between the capture probes and DNA library fragments comprising the DNA target region

Methodology Applied
Scientific EffectHybridization:

Implementation Method 3

performing primer extension and amplification of the DNA library fragments comprising the DNA target region

Methodology Applied
Scientific EffectDNA replication:

Implementation Method 4

amplification of the DNA library fragments comprising the DNA target region

Methodology Applied
Scientific EffectPCR amplification:

Data Source

PatentEP3504347B1Methods for quantitative genetic analysis of DNA fragments using adaptors with unique molecular identifiers and sample tags
Publication Date: 2025.11.12 RESOLUTION BIOSCIENCE INC
  • EP3504347B1 patent drawingFigure 1~2
  • EP3504347B1 patent drawingFigure 3
  • EP3504347B1 patent drawingFigure 4A~4B

AI summary

The present invention includes compositions and methods useful for the detection of a mutational change, SNP, translocation, inversion, deletion, change in copy number, or other genetic variation within a sample of cellular genomic DNA or cell-free DNA (cfDNA). In some embodiments, the compositions and methods of the present invention provide an extremely high level of resolution that is particularly useful in detecting copy number variations in a small fraction of the total cfDNA from a biological sample (e.g., blood).