Molecular Inversion Probe Assay for Structural Variant Detection

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Solution Overview

Problem

Existing molecular inversion probe (MIP) assays struggle to detect structural variants such as insertions, inversions, translocations, and deletions due to interference from absent or incomplete targeting arm hybridization sites, leading to un-circularized MIPs being discarded and valuable information about structural variants being lost.

Innovation Solution

The method involves using MIPs to detect structural variants by allowing two MIPs to ligate together without circularization, which occurs when a nucleic acid contains a structural variant, and then sequencing the inter-probe product to report the presence of structural variants, while also sequencing circularized MIPs to detect substitutions and small structural variants.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If MIPs are used to detect mutations, then substitution detection is improved, but structural variant detection capability deteriorates due to absent or incomplete targeting arm hybridization sites

Engineering Contradiction:
Improvesubstitution detection accuracyVSAvoidstructural variant detection capability
Core Design Contradiction:
Measurement precisionVSAdaptability or versatility

Solution Approach 1:

The invention recovers information that would otherwise be discarded by treating un-circularized MIPs not as waste products to be removed by exonuclease, but as valuable signals containing structural variant information. The un-circularized MIPs are protected from digestion and sequenced to detect structural variants, thereby transforming a previously discarded byproduct into a useful diagnostic signal.

Inventive Principle:
Principle #34Discarding and recovering

Solution Approach 2:

The MIP assay is enhanced to perform multiple functions simultaneously: circularized MIPs detect substitutions and small indels, while un-circularized MIPs detect structural variants. This multi-functional approach allows a single assay platform to comprehensively screen for different types of genetic mutations without requiring separate specialized methods.

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

2Reliability

If un-circularized MIPs are discarded to maintain clean assay results, then false positive reduction is improved, but structural variant information is lost

Engineering Contradiction:
Improveassay accuracyVSAvoidstructural variant data
Core Design Contradiction:
ReliabilityVSLoss of information

Solution Approach 1:

Instead of discarding un-circularized MIPs as contaminants, the invention recovers and utilizes them as informative signals. By protecting these molecules from exonuclease digestion through phosphorothioate modifications and sequencing them separately, the assay retrieves structural variant information that would otherwise be permanently lost.

Inventive Principle:
Principle #34Discarding and recovering

Solution Approach 2:

The assay results are segmented into two distinct categories: circularized MIP sequences for substitution detection and un-circularized MIP sequences for structural variant detection. This segmentation allows each type of mutation to be analyzed with appropriate methods while maintaining overall assay reliability and preventing false positives from mixing different signal types.

Inventive Principle:
Principle #1Segmentation

3Area of stationary object

If MIPs are designed to hybridize to flanking regions, then target coverage is improved, but hybridization efficiency deteriorates when structural variants separate the targeting arms

Engineering Contradiction:
Improvetarget coverage regionVSAvoidhybridization efficiency
Core Design Contradiction:
Area of stationary objectVSReliability

Solution Approach 1:

The assay dynamically responds to different genomic configurations by producing distinct molecular outcomes: when targeting arms are properly positioned, MIPs circularize; when structural variants separate the arms, MIPs remain un-circularized. This dynamic response allows the system to adapt to various genomic architectures while maintaining reliable detection through appropriate molecular formatting.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The invention recovers the hybridization signal from MIPs that fail to circularize due to structural variants. By protecting these un-circularized probes from degradation and sequencing them, the assay retrieves valuable information about structural variants that would otherwise be lost, transforming hybridization failure into a productive detection signal.

Inventive Principle:
Principle #34Discarding and recovering

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 enables robust and reliable detection and reporting of mutations, including small structural variants and large chromosomal abnormalities, thereby improving the accuracy of carrier screening and genetic analysis.

Implementation Method 1

Each MIP has two linked oligonucleotide targeting arms that are designed to hybridize to a strand of nucleic acid in positions that flank a region of interest

Methodology Applied
Scientific EffectHybridization: Absorption (physical)

Implementation Method 2

Upon successful hybridization, the two targeting arms of one MIP are connected together in a ligation step into a covalently closed circle

Methodology Applied
Scientific EffectLigation: Chemical Bonding

Implementation Method 3

Unbound DNA and un-circularized MIPs are typically digested away by an exonuclease after which the circularized MIPs are used in amplification or sequencing reactions

Methodology Applied
Scientific EffectExonuclease digestion: Hydrolysis

Implementation Method 4

The inter-probe product can be amplified and/or sequenced. Preferably, the inter-probe product is protected from exonuclease digestion, for example, by including a phosphorothioate base in the MIP backbone

Methodology Applied
Scientific EffectPolymerization: Chemical Bonding

Data Source

PatentEP4095261B1Screening for structural variants
Publication Date: 2025.05.28 MOLECULAR LOOP BIOSOLUTIONS LLC
  • EP4095261B1 patent drawingFigure 1
  • EP4095261B1 patent drawingFigure 2
  • EP4095261B1 patent drawingFigure 3

AI summary

The invention relates to carrier screening and methods for describing a structural variant, such as a large rearrangement or chromosomal abnormality, in a person's genome using probes that are designed to determine the person's genetic sequence and reveal substitution mutations and small structural variants. Identifying a structural variant may include exposing a nucleic acid to a plurality of probes. Each probe has a linked pair of targeting arms designed to hybridize upstream and downstream of a target in a genome. The method includes hybridizing two of the probes to the nucleic acid and attaching the two probes together to create an inter-probe product as well as detecting the inter-probe product and reporting a structural variant of the genome in the nucleic acid.