Biomarker Panel Prognostic for Anti-TNF Alpha Therapy Response

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Solution Overview

Problem

Current anti-TNF alpha therapies for Inflammatory Bowel Disease (IBD) have suboptimal administration due to high non-response rates, associated risks, and high costs, lacking clear predictive factors for response or loss of response, necessitating a more accurate and affordable method to identify suitable patients.

Innovation Solution

A method involving the measurement of specific biomarkers in biological samples to generate a TNF alpha prognostic score, determining candidate status for anti-TNF alpha therapy, using a panel of biomarkers like WNK2, OCRL, ASB7, PCBP3, AMPD2, FAM155A, and IL13RA2, through techniques such as qRT-PCR or NanoString nCounter analysis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If anti-TNF alpha therapy is administered to IBD patients, then treatment coverage is expanded, but response rate remains low (greater than 50% do not respond)

Engineering Contradiction:

Improvetreatment coverageVSAvoidresponse rate

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The patent applies preliminary action by measuring biomarker expression levels (such as WNK2, OCRL, ASB7, PCBP3, AMPD2, FAM155A, and IL13RA2) before administering anti-TNF alpha therapy to predict treatment response. This pre-assessment allows clinicians to identify patients likely to respond before committing to the therapy, thereby improving the reliability of treatment outcomes while maintaining broad adaptability in patient selection.

Inventive Principle:

Principle #10Preliminary action

2Adaptability or versatility

If anti-TNF alpha therapy is used broadly, then more patients receive treatment, but healthcare costs increase

Engineering Contradiction:

Improvetreatment accessibilityVSAvoidhealthcare cost

Core Design Contradiction:

Adaptability or versatilityVSLoss of energy

Solution Approach 1:

The patent implements a cost-effective preliminary screening approach using biomarker measurement (via qRT-PCR, isothermal amplification, or NanoString nCounter) to predict therapy response before treatment initiation. This allows healthcare systems to maintain broad treatment accessibility for eligible patients while avoiding unnecessary costs associated with treating non-responders, thereby reducing overall healthcare expenditure on anti-TNF alpha therapies.

Inventive Principle:

Principle #10Preliminary action

3Ease of operation

If single biomarkers are used for prediction, then test simplicity is maintained, but predictive accuracy is insufficient

Engineering Contradiction:

Improvetest simplicityVSAvoidpredictive accuracy

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The patent merges multiple biomarker measurements (WNK2, OCRL, ASB7, PCBP3, AMPD2, FAM155A, and IL13RA2) into a composite prognostic score that predicts anti-TNF alpha therapy response. While the assay measures multiple targets, the use of standardized techniques (qRT-PCR, isothermal amplification, or NanoString nCounter) and automated scoring algorithms maintains operational simplicity, achieving both high measurement precision and ease of use in clinical settings.

Inventive Principle:

Principle #5Merging (Combining)

Data Source

PatentUS20240327918A1A baseline gene expression-based prognostic for Anti-inf alpha therapy response ni patients with inflammatory bowel disease

Publication Date: 2024.10.03 INFLAMMATIX INC

AI summary

Systems, methods, compositions, apparatuses, and kits for determining the responsiveness of subjects with inflammatory bowel disease (IBD) to anti-TNF alpha therapy using biological samples obtained from the subjects, are provided herein. The disclosed methods and compositions involve biomarkers identified from the application of a machine learning workflow to TNF alpha response training data from biological samples. The biomarkers allow the calculation of a score that can be used to determine the TNF alpha responder status of the subjects.