Biomarker Detection Assay Using Dual Binding Agents for Specificity

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Solution Overview

Problem

Current biomarker tests for cancer, such as those using CA125 for ovarian cancer and CA 15-3 for breast cancer, suffer from high false positives due to non-specific binding issues, lacking specificity and sensitivity for early detection and monitoring.

Innovation Solution

A composition and method utilizing a first binding agent that binds N-glycolylneuraminic acid and a second binding agent that binds a non-sialic acid component without binding N-glycolylneuraminic acid, allowing for the control of non-specific binding and improved detection assays by isolating or depleting the non-sialic acid component.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a single binding agent for N-glycolylneuraminic acid is used in detection assays, then the assay can detect the target biomarker, but non-specific binding to non-sialic acid components causes high false positives and reduced specificity

Engineering Contradiction:

Improvespecificity of biomarker detectionVSAvoidfalse positive rate

Core Design Contradiction:

Measurement precisionVSReliability

Solution Approach 1:

The binding agent is divided into two separate functional components: a first binding agent that specifically binds N-glycolylneuraminic acid, and a second binding agent that binds non-sialic acid components. This segmentation allows each component to perform its specific function, with the second agent controlling background binding and the first agent providing specific detection signal.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The second binding agent acts as an intermediary that controls and modulates the background binding signal from non-sialic acid components. By introducing this intermediary element, the assay can distinguish between specific biomarker binding and non-specific background binding, thereby improving specificity and reducing false positives.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Measurement precision

If a binding agent with high affinity for N-glycolylneuraminic acid is used, then detection sensitivity is improved, but non-specific binding to non-sialic acid components increases background noise

Engineering Contradiction:

Improvesensitivity of biomarker detectionVSAvoidbackground noise from non-specific binding

Core Design Contradiction:

Measurement precisionVSObject-generated harmful factors

Solution Approach 1:

The non-specific binding to non-sialic acid components, which was previously a harmful source of background noise, is converted into a useful signal by the second binding agent. This agent specifically recognizes and binds the non-sialic acid components, allowing the assay to measure and subtract background binding from total binding to obtain accurate specific biomarker levels.

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

Solution Approach 2:

The second binding agent serves as an intermediary that quantifies the background binding component. By introducing this mediator, the assay can separate the specific biomarker signal from the non-specific background noise, thereby improving sensitivity while controlling background interference.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Productivity

If biomarker testing is performed to enable rapid high throughput cancer detection, then productivity is improved, but specificity and sensitivity are compromised due to non-specific binding

Engineering Contradiction:

Improvethroughput of cancer detectionVSAvoidspecificity and sensitivity of detection

Core Design Contradiction:

ProductivityVSMeasurement precision

Solution Approach 1:

The detection assay is segmented into two parallel measurement streams: one measuring total binding (specific + non-specific) and another measuring background binding (non-specific only). This segmentation allows both measurements to be performed in high throughput while maintaining accuracy, as each measurement can be processed independently and rapidly.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The two binding agents are used in combination within the same assay system, allowing simultaneous measurement of specific and non-specific binding. This merging of multiple functions into a unified assay platform enables high throughput processing while maintaining the specificity and sensitivity needed for accurate cancer detection.

Inventive Principle:

Principle #5Merging (Combining)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Enhances the specificity and sensitivity of cancer biomarker detection assays, enabling more accurate diagnosis and prognosis by reducing background noise and improving the detection of N-glycolylneuraminic acid levels in biological samples.

Implementation Method 1

a first binding agent capable of binding an N-glycolylneuraminic acid, or a derivative thereof

Methodology Applied

Scientific EffectMolecular recognition:

Implementation Method 2

a second binding agent capable of binding the non-sialic acid component of the biological sample, and which does not substantially bind the N-glycolylneuraminic acid

Methodology Applied

Scientific EffectSelective binding:

Data Source

PatentUS20240239846A1Methods of analysing a sample

Publication Date: 2024.07.18 UNIVERSITY OF ADELAIDE

AI summary

The present disclosure relates to compositions, kits and methods for preparing and/or analysing biological samples from a subject. These compositions, kits and methods may be useful in applications, such as diagnosing cancer and/or or determining a prognosis therefor.