Parallel Primer DNA Rearrangement Detection in Liquid Biopsies

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Solution Overview

Problem

Existing methods for analyzing cell-free DNA in liquid biopsies struggle with low sensitivity and specificity in detecting DNA rearrangements, leading to poor signal-to-noise ratios and missed biomarkers for cancer therapy, particularly in non-invasive liquid biopsies.

Innovation Solution

A method using 5' to 3' exonuclease negative, strand displacement negative DNA polymerase for primer extension, combined with parallel-oriented primers that block extension on wild-type regions and capture moieties, to selectively detect DNA rearrangements and other modifications.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If existing methods are used to analyze cell-free DNA in liquid biopsies, then the procedure is non-invasive, but the detection sensitivity and specificity for DNA rearrangements are low resulting in poor signal-to-noise ratios

Engineering Contradiction:
Improvedetection sensitivity and specificityVSAvoidsignal-to-noise ratio
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The method divides the detection process into multiple selective steps: (1) hybridization of DNA fragments with specific primers targeting rearrangement breakpoints, (2) selective extension only of primers bound to rearranged DNA using 5' exonuclease-negative polymerase, and (3) enrichment of extended products. This segmentation allows each step to contribute to improving signal-to-noise ratio by eliminating non-specific amplification at each stage.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention applies local quality by using 5' exonuclease-negative DNA polymerase specifically for the extension step, which prevents degradation of the primer-template hybrid and maintains the integrity of the rearrangement-specific signal. This localized enzymatic property enhancement improves detection specificity without affecting other steps of the process.

Inventive Principle:
Principle #3Local quality

2Measurement precision

If existing methods are used to detect DNA rearrangements, then the analysis covers broad genomic regions, but the selectivity for rearrangements over wild type DNA is poor resulting in significant detection of wild type DNA

Engineering Contradiction:
Improveselectivity for rearrangementsVSAvoidwild type DNA detection
Core Design Contradiction:
Measurement precisionVSQuantity of substance

Solution Approach 1:

The method extracts and isolates only the rearrangement-specific signal by using primers that hybridize exclusively to rearranged DNA sequences. The 5' exonuclease-negative polymerase further extracts the specific signal by extending only those primers that are properly hybridized to rearrangement breakpoints, while leaving wild-type DNA untouched. This selective extraction dramatically improves rearrangement detection selectivity.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention performs preliminary hybridization of primers to the DNA sample before extension, allowing only rearrangement-specific primers to bind to their target sequences. This preliminary selective binding step ensures that subsequent extension and amplification occur only on rearranged DNA templates, preventing amplification of wild-type DNA and improving overall selectivity.

Inventive Principle:
Principle #10Preliminary action

3Ease of operation

If liquid biopsy methods are used for cancer detection, then the procedure is non-invasive, but the amount of nucleic acids released into body fluids is low and variable

Engineering Contradiction:
Improvenon-invasive samplingVSAvoidamount of nucleic acids
Core Design Contradiction:
Ease of operationVSQuantity of substance

Solution Approach 1:

The method employs self-service by using the limited cell-free DNA present in the sample to drive the entire detection process. The rearrangement-specific primers automatically hybridize to and amplify only the relevant tumor-derived DNA fragments, eliminating the need for additional enrichment steps or larger sample volumes. This self-amplifying approach maximizes the utility of the small amount of nucleic acid available in liquid biopsy samples.

Inventive Principle:
Principle #25Self-service

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 detection of DNA rearrangements and modifications in cell-free DNA, improving the accuracy of cancer diagnosis and therapy prediction by enriching for relevant biomarkers in liquid biopsies.

Implementation Method 1

contacting the primer-annealed DNA with a 5' to 3' exonuclease negative, strand displacement negative DNA polymerase, thereby producing a primer-extended sample

Methodology Applied
Scientific EffectDNA polymerase catalysis: Enzyme

Implementation Method 2

contacting the DNA with a plurality of primers, wherein the plurality of primers comprises at least two primers that anneal in a parallel orientation to a target region

Methodology Applied
Scientific EffectNucleic acid hybridization:

Data Source

PatentEP4729633A2Methods for detecting nucleic acid variants
Publication Date: 2026.04.22 GUARDANT HEALTH INC
  • EP4729633A2 patent drawingFigure 1A
  • EP4729633A2 patent drawingFigure 1B
  • EP4729633A2 patent drawingFigure 1C

AI summary

Provided herein is a DNA analysis method for detecting a presence or absence of a DNA molecule that comprises a structural variation, comprising contacting the DNA with at least two primers that anneal in a parallel orientation to a target region and contacting the primer-annealed DNA with a 5' to 3' exonuclease negative, strand displacement negative DNA polymerase.