Biomarker Detection Assay for Predictive Treatment Selection

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Solution Overview

Problem

Current cancer therapies have a narrow therapeutic index and are often ineffective or harmful due to differential patient responses, necessitating the development of predictive markers to identify patients likely to benefit from specific treatments.

Innovation Solution

A method for determining the presence, absence, or quantity of multiple biomarkers in a biological sample to predict treatment response, using gene expression assays that identify predictors such as androgen receptor variants and fusion genes, allowing for personalized cancer treatment selection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If multiple separate assays are used to detect different biomarkers, then each biomarker can be detected with high precision, but the assay complexity and time required increase significantly

Engineering Contradiction:
Improvebiomarker detection precisionVSAvoidassay complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent combines multiple biomarker detection assays into a single integrated assay platform. The system simultaneously detects multiple biomarkers (such as PSMA, PCA3, and other prostate cancer markers) in one test, eliminating the need for separate assays for each biomarker while maintaining detection precision through standardized protocols and unified sample processing

Inventive Principle:
Principle #5Merging (Combining)

2Measurement precision

If multiple separate assays are used to detect different biomarkers, then each biomarker can be detected with high precision, but the time required for detection increases

Engineering Contradiction:
Improvebiomarker detection precisionVSAvoiddetection time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The integrated assay platform processes multiple biomarkers simultaneously in a single test run, reducing the total detection time from multiple sequential assays to one unified process. The system uses parallel detection methods and standardized protocols that allow concurrent analysis of multiple biomarkers without compromising precision

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The assay performs preliminary sample preparation and processing steps once, before dividing the sample for simultaneous detection of multiple biomarkers. This preliminary action eliminates redundant sample preparation steps that would otherwise be required for each separate assay, significantly reducing total detection time while maintaining precision

Inventive Principle:
Principle #10Preliminary action

3Productivity

If cancer therapy is administered without predictive marker analysis, then treatment can be started immediately, but patients may receive ineffective or harmful therapy

Engineering Contradiction:
Improvetreatment initiation speedVSAvoidtreatment efficacy
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The assay performs predictive marker analysis as a preliminary step before treatment initiation. By identifying patients with favorable predictive markers (such as high PSMA expression or positive PCA3 results) before therapy begins, the system ensures that only appropriate candidates receive specific treatments, improving treatment efficacy while maintaining a streamlined process that does not significantly delay overall treatment initiation

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS10041125B2Assay for predictive biomarkers
Publication Date: 2018.08.07 JANSSEN PHARMA NV

AI summary

The present invention provides assays for detecting presence or quantity of multiple biomarkers in one biological sample.