Biomarker Panel for Non-Invasive Mucosal Healing Assessment

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Solution Overview

Problem

Current treatments for ulcerative colitis lack effective non-invasive methods to monitor mucosal healing, relying on repeated endoscopies that burden patients and pose risks, with no universal response to therapies and a need for identifying responders versus non-responders.

Innovation Solution

A multi-immune pathway test panel using biomarkers such as Neutrophils count, LL-37, Chitinase 3-like 1, C-reactive protein, and NGAL-MMP-9 measured in blood samples to assess mucosal healing, providing a non-invasive alternative to endoscopic evaluation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If repeated endoscopies are used to monitor mucosal healing, then measurement precision is improved, but patient burden increases and risks are posed

Engineering Contradiction:

Improvemucosal healing assessmentVSAvoidpatient burden and risks

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical endoscopic system with a biochemical testing system. Instead of using endoscopes to visually assess mucosal healing, the invention uses blood biomarker measurements (neutrophil count, LL-37, CHI3L1, CRP, NGAL-MMP-9) to non-invasively predict mucosal healing status, thereby eliminating the mechanical invasion and associated risks of repeated endoscopies

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces blood biomarkers as intermediary substances that mediate the assessment of mucosal healing. These biomarkers serve as proxies for the actual mucosal state, allowing indirect measurement of healing status through blood tests rather than direct endoscopic visualization, thus reducing patient burden and risks

Inventive Principle:

Principle #24Intermediary (Mediator)

2Adaptability or versatility

If current therapies are used for ulcerative colitis, then treatment options are provided, but universal response is not achieved and identification of responders versus non-responders is difficult

Engineering Contradiction:

Improvetreatment response variabilityVSAvoidpatient response prediction

Core Design Contradiction:

Adaptability or versatilityVSLoss of information

Solution Approach 1:

The patent performs preliminary assessment of mucosal healing status using blood biomarkers before and during treatment. By measuring biomarker levels at baseline and at follow-up points, the system can predict whether a patient will respond to therapy, allowing for early identification of responders versus non-responders and enabling timely treatment adjustments

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent establishes a feedback mechanism where blood biomarker measurements provide real-time information about treatment efficacy. The changes in biomarker levels (neutrophil count, LL-37, CHI3L1, CRP, NGAL-MMP-9) serve as feedback signals that indicate whether the treatment is working, allowing clinicians to adapt treatment strategies based on objective response data

Inventive Principle:

Principle #23Feedback

3Ease of operation

If non-invasive biomarker testing is implemented, then patient burden is reduced, but measurement precision for mucosal healing assessment must be validated

Engineering Contradiction:

Improvenon-invasive testingVSAvoidmucosal healing prediction accuracy

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The patent changes the measurement parameters from direct endoscopic visual assessment to biochemical parameter measurement in blood. By quantifying specific biomarkers (neutrophil count, LL-37 concentration, CHI3L1 concentration, CRP level, NGAL-MMP-9 level), the system transforms the assessment into a non-invasive laboratory test while maintaining predictive accuracy through validated biomarker-selectivity and sensitivity

Inventive Principle:

Principle #35Parameter changes

Data Source

PatentUS11480569B2Biomarker test and method for assessing mucosal healing in response to treatment of ulcerative colitis

Publication Date: 2022.10.25 GLYCOMINDS LLC

AI summary

Mucosal healing is an indication to the disease activity level in patients affected by inflammatory bowel diseases, and it is thus far mainly monitored by endoscopy. Instead or in addition to endoscopy, the invention provides blood test using biomarkers and an index that allows a practitioner to assess the status of mucosal healing, to change or adapt dosage of treatment and to predict which patient will become responder versus non-responder to treatment as assessed by endoscopy. While none of neutrophils cell count, c-reactive protein (CRP), Human type of Cathelicidin (LL-37), or Chitinase 3-like 1 (CHI3L1) alone is able to provide an assessment means of mucosal healing, the invention provides a novel combination of the levels of these biomarkers to assess the level of mucosal healing in relation to endoscopic healing.