ERV Gag Gene Variant Quantification for T1D Risk Detection

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Solution Overview

Problem

Current screening methods for type 1 diabetes (T1D) are inadequate for early diagnosis and disease progression prediction due to their complexity, inaccuracy, and inability to standardize autoantibody testing.

Innovation Solution

A serum biomarker method utilizing deep sequencing to quantify individual sequence variants of the endogenous retrovirus (ERV) Group Antigen (Gag) gene, specifically targeting conserved regions for cost-effective amplicon deep sequencing and RNA-based molecular technology for accurate disease prediction.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If genetic testing is used for T1D screening, then disease risk identification is possible, but the testing process becomes complex and inaccurate

Engineering Contradiction:

Improvedisease risk identification accuracyVSAvoidtesting process complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent extracts and focuses on a specific subset of genetic markers (ERV Gag gene variants) from the complex genome, rather than analyzing all genetic information. This selective extraction simplifies the testing process while maintaining diagnostic accuracy by concentrating on the most relevant genetic elements associated with T1D risk.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent changes the parameter of analysis from traditional HLA gene sequencing to ERV Gag gene variant quantification. This parameter change enables simpler, more accurate testing by focusing on viral genetic elements that provide clearer predictive value for T1D risk without the complexity of analyzing multiple immune pathway genes.

Inventive Principle:

Principle #35Parameter changes

2Loss of information

If autoantibody testing is used for T1D diagnosis, then disease progression information is obtained, but the reagents vary in quality and standardization is difficult

Engineering Contradiction:

Improvedisease progression informationVSAvoidtest standardization

Core Design Contradiction:

Loss of informationVSReliability

Solution Approach 1:

The patent uses molecular copying through DNA sequencing to create standardized digital copies of genetic markers. This digital copying approach eliminates the variability inherent in protein-based autoantibody reagents, providing consistent, reproducible results across different laboratories and test platforms while maintaining disease progression information.

Inventive Principle:

Principle #26Copying

3Loss of time

If traditional biomarker methods are used, then early diagnosis is attempted, but the methods cannot predict who will become diabetic

Engineering Contradiction:

Improveearly diagnosis timingVSAvoiddisease prediction accuracy

Core Design Contradiction:

Loss of timeVSMeasurement precision

Solution Approach 1:

The patent replaces traditional protein-based biomarker detection with molecular genetics sequencing technology. This substitution enables more precise measurement of genetic variants that can predict disease development, allowing earlier and more accurate identification of individuals at risk before clinical symptoms appear.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentUS20250066854A1Biomarker method for early diagnosis of type 1 diabetes

Publication Date: 2025.02.27 DAI YANG

AI summary

A method of early detection of Type 1 diabetes uses a quantitative assay to measure biomarkers of autoimmune diseases at specific short regions of a gene sequence. The assay uses amplicon deep sequencing to quantify individual variants of the ERV Group Antigen (Gag) gene associated with an overactive immune response.