Nasal Epithelial Gene Expression Classifier for Lung Cancer Triage

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Solution Overview

Problem

Current lung cancer screening methods, such as low-dose chest CT, have high false-positive rates and fail to accurately target high-risk individuals, leading to unnecessary invasive procedures and delayed diagnosis of early-stage lung cancer.

Innovation Solution

Non-invasive or minimally-invasive methods for diagnosing lung cancer based on gene expression analysis in nasal epithelial cells, using a panel of specific genes to determine differential expression patterns.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If low-dose chest CT screening is performed, then early stage lung cancer detection is improved, but false-positive rate increases leading to unnecessary invasive procedures

Engineering Contradiction:

Improveearly stage lung cancer detectionVSAvoidfalse-positive rate

Core Design Contradiction:

Measurement precisionVSObject-generated harmful factors

Solution Approach 1:

The patent introduces nasal epithelial gene expression analysis as an intermediary test between LDCT screening and invasive procedures. This mediator provides molecular characterization of nodules, helping to distinguish benign from malignant lesions without requiring immediate invasive intervention, thereby reducing false-positive impact while maintaining early detection capability

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The diagnostic workflow is segmented into multiple stages: initial LDCT screening, followed by nasal epithelial gene expression analysis for intermediate assessment, and finally invasive procedures only for high-risk cases. This segmentation allows progressive refinement of diagnostic certainty, reducing unnecessary invasive procedures while preserving early detection

Inventive Principle:

Principle #1Segmentation

2Quantity of substance

If current screening guidelines based on age and smoking history are used, then screening coverage is increased, but screening accuracy and resource utilization deteriorate

Engineering Contradiction:

Improvescreening coverageVSAvoidscreening accuracy

Core Design Contradiction:

Quantity of substanceVSMeasurement precision

Solution Approach 1:

The patent changes the screening parameters from demographic factors (age, smoking history) to molecular biomarkers (nasal epithelial gene expression profiles). This parameter transformation enables more precise identification of true high-risk individuals, improving screening accuracy while potentially optimizing resource allocation by targeting those most likely to benefit

Inventive Principle:

Principle #35Parameter changes

3Reliability

If invasive procedures are performed for all screen-detected nodules, then diagnostic certainty is improved, but patient burden and unnecessary procedures increase

Engineering Contradiction:

Improvediagnostic certaintyVSAvoidpatient burden

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

Instead of applying invasive procedures universally to all nodules, the patent applies them partially and selectively based on nasal epithelial gene expression risk stratification. This partial action approach maintains diagnostic certainty for high-risk cases while avoiding unnecessary patient burden for low-risk cases

Inventive Principle:

Principle #16Partial or excessive action

Data Source

PatentUS12577620B2Nasal epithelium gene expression signature and classifier for the prediction of lung cancer

Publication Date: 2026.03.17 TRUSTEES OF BOSTON UNIV

AI summary

This application provides assays and methods for diagnosis and prognosis of lung cancer using expression analysis of one or more genes from a biological sample comprising nasal epithelial cells. The assays and methods are non-invasive and accurately detect the presence or absence of lung cancer relative to, for example, more invasive techniques, such as bronchoscopy. Similarly, the assays and methods described provide non-invasive ways of accurately identifying the smoking history of a subject.