Gene Expression Profile Kit for Lung Cancer Diagnosis

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Solution Overview

Problem

Current diagnostic methods for lung cancer, such as low dose spiral CT scans, often result in overtreatment due to the detection of benign nodules, and lack a non-invasive, cost-effective way to differentiate between malignant and benign lung nodules.

Innovation Solution

A composition or kit that includes at least 7 polynucleotides or oligonucleotides that hybridize to different genes or gene fragments in a patient sample, allowing for the detection of changes in gene expression profiles to distinguish between cancerous and non-cancerous lung nodules.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If low dose spiral CT scans are used to screen high-risk patients, then early stage lung nodules can be detected, but the large number of detected nodules results in overtreatment and burden on healthcare systems

Engineering Contradiction:

Improvedetection accuracyVSAvoidhealthcare efficiency

Core Design Contradiction:

ReliabilityVSProductivity

Solution Approach 1:

The patent introduces an intermediary diagnostic test (gene expression profiling or other molecular markers) between CT scan detection and invasive biopsy/surgery. This intermediary step characterizes the detected nodules to distinguish malignant from benign cases, reducing unnecessary overtreatment while maintaining detection sensitivity.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The diagnostic process is segmented into multiple stages: initial CT screening, followed by molecular characterization of detected nodules, and then selective invasive procedures only for high-risk cases. This segmentation allows efficient triage of patients based on nodule characteristics.

Inventive Principle:

Principle #1Segmentation

2Measurement precision

If invasive biopsy or surgery is performed to differentiate benign from malignant nodules, then diagnostic accuracy is improved, but patient burden, cost, and risk increase

Engineering Contradiction:

Improvediagnostic accuracyVSAvoidpatient burden

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent introduces an intermediary non-invasive or minimally invasive diagnostic test (gene expression profiling, molecular markers in blood/sputum) between CT scan detection and invasive biopsy/surgery. This intermediary step characterizes the detected nodules to distinguish malignant from benign cases, reducing unnecessary invasive procedures.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces mechanical/invasive diagnostic methods (bronchoscopy, biopsy, surgery) with molecular-based diagnostic approaches (gene expression profiling, liquid biopsy, molecular markers in blood or sputum). This substitution maintains diagnostic accuracy while eliminating physical invasion and associated risks.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If serial CT imaging is used for indeterminate nodules, then monitoring is provided, but costs, radiation exposure, and delayed treatment increase

Engineering Contradiction:

Improvemonitoring capabilityVSAvoidtreatment delay

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The patent introduces molecular characterization (gene expression profiling, molecular markers) as an intermediary assessment tool that can rapidly stratify nodules into high-risk and low-risk categories. This allows immediate treatment decisions for high-risk cases without prolonged serial imaging, reducing treatment delays.

Inventive Principle:

Principle #24Intermediary (Mediator)

4Ease of operation

If a simple blood test is developed for lung cancer diagnosis, then accessibility and cost-effectiveness improve, but diagnostic sensitivity and specificity must be maintained

Engineering Contradiction:

Improvetest accessibilityVSAvoiddiagnostic accuracy

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The patent develops a universal blood-based molecular test platform that can serve multiple diagnostic functions: detecting lung cancer, characterizing nodules, and potentially monitoring treatment response. This multi-functional approach maintains accessibility while achieving diagnostic accuracy through standardized molecular markers.

Inventive Principle:

Principle #6Universality (Multi-functionality)

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

Enables non-invasive, cost-effective detection of lung cancer by distinguishing between cancerous and non-cancerous nodules through changes in gene expression profiles, potentially reducing overtreatment and improving patient outcomes.

Implementation Method 1

at least seven (7) or more polynucleotides or oligonucleotides, wherein each polynucleotide or oligonucleotide hybridizes to a different gene, gene fragment, gene transcript or expression product in a patient sample

Methodology Applied

Scientific EffectHybridization:

Data Source

PatentUS20250137066A1Compostions and methods for diagnosing lung cancers using gene expression profiles

Publication Date: 2025.05.01 THE WISTAR INST OF ANATOMY & BIOLOGY

AI summary

Methods and compositions are provided for diagnosing lung cancer in a mammalian subject by use of 7 or more selected genes, e.g., a gene expression profile, from the blood of the subject which is characteristic of disease. The gene expression profile includes 7 or more genes of Table I, Table II, Table III, Table IV or Table IX herein.