Split Intein Reporter for Splice Event Detection

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Solution Overview

Problem

Current methods for detecting specific splice events in genes lack high-throughput and spatiotemporal resolution, making it difficult to track and diagnose neurological and neuromuscular diseases such as tauopathies, which are associated with imbalances in tau protein isoforms, and are not suitable for real-time monitoring or early-stage disease detection.

Innovation Solution

A method involving the insertion of a split intein-heterologous polynucleotide construct into an exon of interest, where the split intein excises itself from the expression product, allowing for the detection of specific splice events with high-throughput and spatiotemporal resolution, and includes the use of CRISPR/Cas9 for precise gene editing and monitoring.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If laborious methods based on RT-qPCR, immunoblotting, or fluorescent protein-fusion assays are used, then splice events can be detected, but the methods lack high-throughput capability and cannot provide real-time tracking

Engineering Contradiction:
Improvedetection throughputVSAvoidreal-time tracking capability
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The patent replaces traditional mechanical/biochemical detection methods (RT-qPCR, immunoblotting) with a fluorescent reporter system that provides real-time optical detection of splicing events, enabling both high throughput and temporal resolution

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The invention introduces an intein-flanked fluorescent reporter protein as an intermediary that reports splicing events through fluorescence, allowing indirect but real-time monitoring of splice events without disrupting the native splicing machinery

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If conventional detection methods are used, then splice events can be identified, but they cannot provide spatiotemporal resolution for tracking disease progression

Engineering Contradiction:
Improvespatiotemporal resolutionVSAvoiddetection system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent uses fluorescent reporter proteins that emit light at specific wavelengths to indicate splicing events, providing spatial and temporal information through optical signals that can be imaged and tracked

Inventive Principle:
Principle #32Color changes

Solution Approach 2:

The invention divides the detection function into separate modular components: the intein-flanked reporter construct inserted into specific exons, and the fluorescent reporter protein that provides the signal, allowing targeted detection of specific splice events

Inventive Principle:
Principle #1Segmentation

3Reliability

If RNA-based methods are used to detect splicing events, then mRNA presence can be detected, but they cannot reliably indicate active protein translation

Engineering Contradiction:
Improvetranslation status indicationVSAvoidtranslationally-arrested mRNA interference
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The intein-flanked reporter protein is translated along with the protein of interest, and the intein automatically excises the reporter upon splicing, providing self-contained evidence of successful translation without requiring separate assays

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The invention merges the detection reporter with the protein of interest through the intein-flanked construct, ensuring that detection only occurs when the mRNA is actively translated into protein rather than remaining in an arrested state

Inventive Principle:
Principle #5Merging (Combining)

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

Enables non-invasive, real-time tracking of specific splice events with high sensitivity and specificity, allowing for early detection of diseases like tauopathies and other neurodegenerative disorders, and can be used for therapeutic intervention.

Implementation Method 1

the expression product of the split intein - heterologous polynucleotide construct excises itself from the expression product of the specific splice product

Methodology Applied
Scientific EffectSelf-splicing:

Data Source

PatentEP3921423B1Method for detecting a specific splice event of a gene of interest
Publication Date: 2023.01.04 HELMHOLTZ ZENT MUENCHEN DEUT FORSCHUNGSZENTRUM FUER GESUNDHEIT & UMWELT (GMBH)
  • EP3921423B1 patent drawingFigure 1a
  • EP3921423B1 patent drawingFigure 1b
  • EP3921423B1 patent drawingFigure 2a

AI summary

The invention provides a method for detecting a specific splice event of a gene of interest, wherein the specific splice event creates a specific splice product, which comprises an exon of interest, wherein the method comprises: (i) Inserting a split intein – heterologous polynucleotide construct into the exon of interest, wherein the split intein comprises an N-terminal splicing region upstream of the heterologous polynucleotide and a C-terminal splicing region downstream of the heterologous polynucleotide; and (ii) detecting the heterologous polynucleotide and/or the expression product of the heterologous polynucleotide. The present invention also provides the use of the split intein – heterologous polynucleotide construct, the nucleic acid encoding this construct, the vector and the host cell comprising the nucleic acid as well as a kit for detecting a specific splice event of a gene of interest.