Bladder Cancer Diagnosis via 14-Gene Expression Panel

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Solution Overview

Problem

Current bladder cancer diagnosis methods are invasive, lack sensitivity and specificity for low-grade tumors, and rely heavily on urinary cytology, which is observer-dependent and limited in detecting non-invasive forms, necessitating a more reliable non-invasive marker for early detection and prognosis.

Innovation Solution

A non-invasive bladder cancer diagnosis and prognosis method based on the detection and quantification of specific gene expression patterns in bladder fluids using quantitative real-time PCR, employing a combination of 14 identified marker genes to classify tumors and predict aggressiveness.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If urinary cytology is used for bladder cancer diagnosis, then the diagnosis can be performed non-invasively, but the sensitivity and specificity for low-grade tumors are insufficient and observer dependency increases

Engineering Contradiction:

Improvenon-invasive diagnosisVSAvoidsensitivity and specificity

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The patent segments the diagnosis into multiple independent molecular markers (MAGEA3, CTSE, CRH, IGF2, KLF9, POSTN, SLC1A6, TERT, MCM10, ASAM, PPP1R14D, C14orf78, KRT20) that can be detected separately through real-time PCR. Each marker provides independent diagnostic information, and their combined analysis improves overall diagnostic accuracy while maintaining non-invasive urine-based sampling.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent changes the diagnostic parameters from traditional cytological assessment to molecular gene expression levels. By measuring the expression levels of multiple specific genes through real-time quantitative PCR, the system achieves higher sensitivity and specificity for detecting low-grade tumors while eliminating observer dependency through objective numerical measurements.

Inventive Principle:

Principle #35Parameter changes

2Device complexity

If traditional diagnosis methods are used, then the procedure is simpler, but the economic burden on healthcare increases due to repeated invasive procedures and poor prognosis management

Engineering Contradiction:

Improvediagnosis procedure complexityVSAvoiddiagnosis accuracy and prognosis prediction

Core Design Contradiction:

Device complexityVSReliability

Solution Approach 1:

The patent performs preliminary molecular characterization of tumors at diagnosis using the 14-gene panel. This preliminary action provides prognostic information and risk stratification early in the diagnostic process, allowing for more informed treatment decisions and reducing the need for repeated invasive procedures by improving initial diagnosis accuracy and enabling better disease management.

Inventive Principle:

Principle #10Preliminary action

3Productivity

If observer-dependent cytology is used, then the diagnostic process is faster, but the variability in results increases due to human interpretation differences

Engineering Contradiction:

Improvediagnosis speedVSAvoidobserver variability

Core Design Contradiction:

ProductivityVSMeasurement precision

Solution Approach 1:

The patent replaces the mechanical/visual assessment system of traditional cytology with an automated molecular detection system based on real-time quantitative PCR. This substitution eliminates human observer variability by using objective, standardized molecular measurements that can be automatically quantified and compared against established thresholds, while maintaining rapid diagnostic throughput.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

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

This method provides a highly accurate, non-invasive means to detect and classify bladder cancer, improving early detection and prognosis by reducing observer variability and enhancing sensitivity and specificity, particularly for low-grade tumors, thereby facilitating personalized treatment and reducing the economic burden on healthcare.

Implementation Method 1

detection and quantification of specific gene expression patterns in bladder fluids using quantitative real-time PCR

Methodology Applied

Scientific EffectPCR amplification:

Implementation Method 2

employing a combination of 14 identified marker genes to classify tumors and predict aggressiveness

Methodology Applied

Scientific EffectFluorescence: Fluorescence

Data Source

PatentUS9097715B2Bladder cancer diagnosis and/or prognosis method

Publication Date: 2015.08.04 FINA BIOTECH

AI summary

A high sensitive and specific non-invasive bladder cancer diagnosis and/or prognosis method based on the detection and quantification of the gene expression of a combination of bladder tumor markers in bladder fluids is provided. A preferred combination of the markers consists of the combination of ANXA10, C14orf78, CTSE, CRH, IGF2, KLF9, KRT20, MAGEA3, POSTN, PPP1R14D, SLC1A6, TERT, ASAM and MCM10 genes.