Circulating Biomarker Panel for Early NEC Detection in CHD

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Solution Overview

Problem

There are no clinically available biomarkers to diagnose, predict, or monitor necrotizing enterocolitis (NEC) in congenital heart disease patients, particularly before clinical symptoms occur, providing prognostic information, or determining the effectiveness of treatment, leading to suboptimal care and increased mortality and length of stay.

Innovation Solution

Utilization of a panel of biomarkers including LRRN1, VASH1, NELL2, DNAJB8, IGFBP1, and others, which can be detected in circulating proteins to diagnose, predict, and monitor NEC in patients with congenital heart disease, identifying distinct proteomic signatures for early intervention and personalized treatment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If no biomarkers are used for NEC diagnosis in CHD patients, then clinical care follows standard protocols, but mortality increases and length of stay increases

Engineering Contradiction:

Improvepatient outcomesVSAvoidlength of stay

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The patent applies preliminary action by developing and implementing biomarker panels that can predict NEC development before clinical symptoms appear. The biomarkers (including LRRN1, VASH1, NELL2, DNAJB8, IGFBP1, and others) are measured in circulating proteins to identify at-risk CHD patients early, allowing preventive interventions to be initiated before the disease progresses, thereby reducing mortality and length of stay

Inventive Principle:

Principle #10Preliminary action

2Measurement precision

If traditional clinical monitoring alone is used, then resource utilization remains standard, but diagnosis occurs only after symptoms appear, reducing treatment effectiveness

Engineering Contradiction:

Improvediagnosis timingVSAvoidtime to diagnosis

Core Design Contradiction:

Measurement precisionVSLoss of time

Solution Approach 1:

The patent enables preliminary diagnosis by measuring specific biomarker panels in circulating proteins of CHD patients before clinical NEC symptoms manifest. This allows clinicians to identify patients at high risk and initiate monitoring or preventive measures early, significantly improving diagnosis timing and treatment effectiveness

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent replaces traditional mechanical/symptom-based clinical monitoring with a biochemical detection system using biomarker panels. Instead of waiting for clinical symptoms (mechanical observation), the system uses laboratory measurement of circulating protein biomarkers to detect NEC risk, achieving more precise and earlier diagnosis

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Ease of operation

If standardized treatment protocols are used without biomarker guidance, then treatment delivery is simplified, but treatment effectiveness decreases due to inability to identify different NEC etiologies

Engineering Contradiction:

Improvetreatment deliveryVSAvoidtreatment effectiveness

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent applies local quality by using biomarker profiles to identify specific NEC etiologies (such as ischemic versus allergic causes) in individual patients. Instead of applying uniform treatment to all patients, the biomarker data enables customization of treatment approach based on the specific pathological mechanism identified in each patient, thereby improving treatment effectiveness

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The patent changes the parameter of treatment personalization by using biomarker panel results to differentiate between distinct NEC phenotypes and etiologies. This allows clinicians to adjust treatment parameters (medication choices, nutritional support, monitoring intensity) based on the specific biomarker profile, moving from standardized to personalized medicine

Inventive Principle:

Principle #35Parameter changes

Data Source

PatentUS20260016488A1Circulating protein biomarkers of necrotizing enterrocolitis

Publication Date: 2026.01.15 THE REGENTS OF THE UNIVERSITY OF COLORADO

AI summary

Disclosed herein are methods, devices, and systems for accurately detecting and/or diagnosing a child having or at risk of developing necrotizing enterocolitis (NEC). In most embodiments, the child is currently suffering from congenital heart disease (CHD). The disclosed methods, devices, and systems may be useful in monitoring the administration and/or response to therapy for CHD and/or NEC. The disclosed methods, devices, and systems may involve detecting one or more biomarkers in a sample from the child, for example a plasma sample, wherein the sample is less than or equal to about 20 microliters.