IBS Diagnostic Panel Using Multi-Marker Statistical Algorithm

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Solution Overview

Problem

Current methods for diagnosing irritable bowel syndrome (IBS) are challenging due to the lack of specific biological, radiographic, or physiological biomarkers, leading to difficulties in distinguishing IBS from other gastrointestinal disorders and understanding its pathophysiology.

Innovation Solution

A method involving the detection of a panel of markers in a biological sample to rule out inflammatory bowel disease and celiac disease, and to rule in IBS, using a combination of anti-gliadin antibodies, inflammatory markers, bacterial antigen antibodies, mast cell markers, and serotonin levels, with a statistical algorithm to generate a disease score for IBS diagnosis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If current diagnostic methods based on Rome III criteria and symptom exclusion are used, then diagnosis can be made without specific biomarkers, but diagnostic accuracy is low and differentiation from other GI disorders is difficult

Engineering Contradiction:
Improvediagnostic accuracyVSAvoiddiagnostic method complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent combines multiple diagnostic markers (anti-gliadin antibodies, inflammatory markers, bacterial antigen antibodies, mast cell markers, serotonin levels) into a unified panel that is simultaneously measured to diagnose IBS and differentiate it from other gastrointestinal disorders, achieving high accuracy without requiring complex sequential testing

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The diagnostic panel serves multiple functions: it rules out inflammatory bowel disease, rules out celiac disease, rules in IBS, and provides insights into pathophysiology, making a single test system that performs what previously required multiple separate diagnostic approaches

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

2Measurement precision

If a panel of multiple markers is detected to rule out IBD and celiac disease and rule in IBS, then diagnostic accuracy improves, but the complexity of the diagnostic method increases

Engineering Contradiction:
Improvediagnostic accuracyVSAvoiddiagnostic method complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent combines multiple diagnostic markers (anti-gliadin antibodies, inflammatory markers, bacterial antigen antibodies, mast cell markers, serotonin levels) into a unified panel that is simultaneously measured to diagnose IBS and differentiate it from other gastrointestinal disorders, achieving high accuracy without requiring complex sequential testing

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The statistical algorithm automatically processes the marker panel results and generates a diagnostic conclusion, reducing the need for complex manual interpretation and making the multi-marker approach as easy to implement as single-marker tests

Inventive Principle:
Principle #25Self-service

Data Source

PatentUS10338083B2Pathway specific markers for diagnosing irritable bowel syndrome
Publication Date: 2019.07.02 PROMETHEUS BIOSCIENCES INC
  • US10338083B2 patent drawing
  • US10338083B2 patent drawing
  • US10338083B2 patent drawing

AI summary

The present invention provides methods for aiding in the diagnosis of irritable bowel syndrome (IBS) in an individual. In particular, the present invention is useful for determining whether the individual does not have either celiac disease or inflammatory bowel disease (IBD), and has IBS and/or a subtype thereof. Thus, the present invention provides an accurate diagnostic prediction of IBS and is useful for guiding treatment decisions.