Fixed Sequence Oligonucleotides for Copy Number Variation Detection

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Solution Overview

Problem

Current methods for detecting genetic abnormalities such as copy number variations (CNVs) are inefficient and lack reproducibility, particularly in identifying fetal aneuploidy and other genetic disorders.

Innovation Solution

The method involves interrogating loci from target genomic regions using fixed sequence oligonucleotides that hybridize and ligate, with capture regions binding to complementary probes on a solid support, allowing for the detection of copy number variations, insertions, deletions, translocations, polymorphisms, and mutations by quantifying relative frequencies of ligation products.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Difficulty of detecting and measuring

If ligation methods are used for evaluating polymorphisms and copy number variations, then detection capability is improved, but assay efficiency and reproducibility deteriorate

Engineering Contradiction:
Improvedetection capabilityVSAvoidassay efficiency
Core Design Contradiction:
Difficulty of detecting and measuringVSProductivity

Solution Approach 1:

The assay is divided into distinct modular steps: hybridization of fixed sequence oligonucleotides to target loci, ligation to form concatemers, amplification, and detection. Each step can be optimized independently, improving overall efficiency while maintaining detection capability for copy number variations and polymorphisms.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Fixed sequence oligonucleotides are designed with predetermined sequences that hybridize to specific target loci before ligation. This preliminary hybridization step ensures specific binding and reduces non-specific ligation, improving both efficiency and reproducibility of the assay.

Inventive Principle:
Principle #10Preliminary action

2Difficulty of detecting and measuring

If ligation methods are used for evaluating polymorphisms and copy number variations, then detection capability is improved, but assay reproducibility deteriorates

Engineering Contradiction:
Improvedetection capabilityVSAvoidassay reproducibility
Core Design Contradiction:
Difficulty of detecting and measuringVSReliability

Solution Approach 1:

The assay separates detection into distinct steps (hybridization, ligation, amplification, detection) with defined conditions for each, reducing variability between runs and improving reproducibility while maintaining ability to detect copy number variations and polymorphisms.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The assay optimizes specific parameters including hybridization temperature, salt concentration, and ligation buffer conditions to ensure consistent and reproducible results across different runs while maintaining high detection capability for genetic abnormalities.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If fixed sequence oligonucleotides with capture regions are used, then detection reliability is improved, but assay complexity increases

Engineering Contradiction:
Improvedetection reliabilityVSAvoidassay complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

Fixed sequence oligonucleotides are designed with multiple functional regions: a target-binding region for specific hybridization to loci and a capture region for subsequent detection. This multi-functionality improves detection reliability across different target sequences while using a standardized assay platform, reducing overall complexity.

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

Solution Approach 2:

The capture region on fixed sequence oligonucleotides serves as an intermediary element that bridges target binding and detection steps. This mediator improves reliability by ensuring specific target capture while allowing the use of standardized detection reagents, simplifying the overall assay design.

Inventive Principle:
Principle #24Intermediary (Mediator)

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

This approach provides a reliable and efficient method for detecting genetic characteristics, including fetal aneuploidy, by quantifying relative frequencies of target genomic regions, enabling accurate diagnosis and treatment options.

Implementation Method 1

interrogating loci from target genomic regions using fixed sequence oligonucleotides that hybridize and ligate

Methodology Applied
Scientific EffectHybridization:

Implementation Method 2

joining the fixed sequence oligonucleotides either directly or indirectly via ligation

Methodology Applied
Scientific EffectLigation: Enzyme

Data Source

PatentEP3175236B1Detection of target nucleic acids using hybridization
Publication Date: 2019.08.21 ARIOSA DIAGNOSTICS INC
  • EP3175236B1 patent drawingFigure 1
  • EP3175236B1 patent drawingFigure 2
  • EP3175236B1 patent drawingFigure 3

AI summary

The present invention provides detection systems and methods for detection of loci and genomic regions in a sample, including mixed samples, using hybridization to an array.