Flow Cytometry Breast Cancer Diagnosis Multi-Gene Profile

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Solution Overview

Problem

Current diagnostic methods for breast cancer, particularly mammograms, suffer from high false-positive rates and over-diagnosis due to reliance on subjective evaluations and limited variables, leading to unnecessary treatments and psychological impacts, and there is a need for more accurate methods to differentiate between primary and metastatic cancers for effective treatment strategies.

Innovation Solution

The development of methods involving flow cytometry to assess cellular breast samples by obtaining and evaluating sample data and cellular data, including the use of markers and labels, to provide more accurate assessments and differentiate between cancerous and non-cancerous cells, as well as metastatic and non-metastatic tumors.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If mammography and immunohistochemistry are used for breast cancer diagnosis, then diagnostic coverage is provided, but false-positive rates increase and measurement precision deteriorates

Engineering Contradiction:

Improvediagnostic accuracyVSAvoidfalse-positive rate

Core Design Contradiction:

ReliabilityVSMeasurement precision

Solution Approach 1:

The patent changes the parameters measured by implementing a multi-gene expression profile assay that evaluates multiple genetic markers simultaneously. This transitions from single-marker immunohistochemistry to comprehensive multi-parameter genomic analysis, thereby improving diagnostic precision and reducing false positives through more accurate molecular characterization of breast cancer samples

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent introduces flow cytometry as an intermediary technology that enables precise measurement of multiple gene expression levels in individual cells. This intermediary method provides objective quantitative data that mediates between subjective pathological evaluation and clinical decision-making, improving measurement precision while maintaining reliability

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of operation

If subjective evaluations by human evaluators are used, then diagnostic assessment is performed, but measurement precision deteriorates due to over-reliance on limited variables

Engineering Contradiction:

Improvediagnostic assessment capabilityVSAvoiddiagnostic accuracy

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The patent replaces the mechanical system of manual pathological evaluation with automated flow cytometry-based gene expression analysis. This substitution eliminates subjective human judgment and limited variable assessment, providing objective, high-precision measurement of multiple genetic markers simultaneously while maintaining ease of operational implementation in clinical settings

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Productivity

If immunohistochemistry of single markers is used, then diagnostic testing is performed, but measurement precision deteriorates due to overestimation in certain cases

Engineering Contradiction:

Improvediagnostic testing efficiencyVSAvoidmarker expression accuracy

Core Design Contradiction:

ProductivityVSMeasurement precision

Solution Approach 1:

The patent merges multiple single-marker immunohistochemistry tests into a unified multi-gene expression profile assay. By combining the evaluation of multiple genetic markers into a single comprehensive test, the patent maintains diagnostic testing efficiency while dramatically improving measurement precision and eliminating the overestimation problems associated with single-marker approaches

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

This approach enhances the accuracy of breast cancer diagnosis by reducing false positives, improving treatment decision-making, and providing better patient outcomes by distinguishing between primary and metastatic cancers, thus addressing the limitations of existing diagnostic methods.

Implementation Method 1

a flow cytometer, and evaluating the obtained data to make an assessment of the sample

Methodology Applied

Scientific EffectLight scattering: Scattering

Implementation Method 2

cellular data, and combinations thereof

Methodology Applied

Scientific EffectFluorescence: Fluorescence

Data Source

PatentUS11988658B2Methods of assessing cellular breast samples and compositions for use in practicing the same

Publication Date: 2024.05.21 INCELLDX

AI summary

Methods are provided for assessing a cellular breast sample. Aspects of the methods include flow cytometrically obtaining sample data, cellular data, and combinations thereof, and then assessing the cellular breast sample based on the obtained data. In addition, compositions, e.g., kits, systems and programming, useful in practicing various embodiments of the methods are provided.