Biomarker Ratio Imaging for Precise DCIS Aggressiveness Stratification

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Solution Overview

Problem

Current methods fail to accurately stratify the aggressiveness of ductal carcinoma in situ (DCIS) lesions, leading to over-treatment of non-aggressive forms and under-treatment of aggressive forms, as existing techniques lack precision in prognostic insight.

Innovation Solution

Biomarker ratio imaging microscopy (BRIM) is employed to analyze biomarker pairs such as CD44/CD24, N-cadherin/E-cadherin, CD74/CD59, using fluorescence imaging to generate high-contrast images that reflect tumor aggressiveness by dividing the expression of positively correlated biomarkers by negatively correlated biomarkers, thereby overcoming optical artifacts due to variations in sample thickness.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional imaging techniques are used to evaluate DCIS lesions, then the diagnostic process is simple, but the precision of stratifying aggressiveness is insufficient

Engineering Contradiction:
Improveprecision of stratifying DCIS aggressivenessVSAvoidcomplexity of imaging methodology
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent segments the evaluation process into multiple distinct steps: (1) obtaining a tissue section, (2) labeling with multiple fluorescently-conjugated antibodies targeting different biomarkers, (3) acquiring separate fluorescent images for each biomarker, and (4) computing ratio images by dividing numerator biomarker intensity by denominator biomarker intensity. This segmentation allows complex multi-biomarker analysis to be performed systematically, improving measurement precision while managing device complexity through structured methodology

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent transforms the evaluation from measuring single biomarker levels to computing ratio parameters (numerator biomarker/denominator biomarker). This parameter transformation enables the system to overcome optical artifacts related to sample thickness and labeling efficiency variations, as the ratio cancels out common multiplicative factors. The parameter change from absolute intensity to relative ratio directly improves measurement precision for aggressiveness stratification

Inventive Principle:
Principle #35Parameter changes

2Loss of information

If single biomarker analysis is performed, then the methodology is straightforward, but the ability to characterize tumor aggressiveness is limited

Engineering Contradiction:
Improveinformation about tumor aggressivenessVSAvoidcomplexity of biomarker analysis system
Core Design Contradiction:
Loss of informationVSDevice complexity

Solution Approach 1:

The patent merges multiple biomarker analyses into a unified ratio-based evaluation system. By selecting numerator biomarkers positively correlated with aggressiveness and denominator biomarkers negatively correlated, the system combines information from multiple biological pathways into a single integrative metric. This merging preserves comprehensive information about tumor aggressiveness while simplifying the interpretation through a unified ratio parameter

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The ratio computation acts as an intermediary that transforms complex multi-biomarker data into a clinically interpretable metric. The ratio image serves as an intermediate representation that encodes aggressiveness information while being resistant to technical variations. This intermediary layer bridges the gap between complex molecular biology and clinical decision-making, reducing information loss

Inventive Principle:
Principle #24Intermediary (Mediator)

3Measurement precision

If fluorescent labeling with multiple antibodies is used, then biomarker detection sensitivity is improved, but optical artifacts due to sample thickness variations increase

Engineering Contradiction:
Improvedetection sensitivity of biomarkersVSAvoidoptical artifacts from sample thickness variations
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent changes the measurement parameter from absolute fluorescent intensity to relative intensity ratio. By computing the ratio of numerator biomarker intensity to denominator biomarker intensity at each pixel location, the system cancels out optical artifacts that affect both biomarkers equally (such as sample thickness variations, excitation light intensity variations, and detector sensitivity variations). This parameter transformation maintains detection sensitivity while eliminating the harmful optical artifacts

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The denominator biomarker serves as a counterweight that compensates for optical artifacts affecting the numerator biomarker. Since both biomarkers are measured in the same tissue section under identical imaging conditions, variations in sample thickness and optical path affect both labels proportionally. The ratio computation uses the denominator as a reference to counterbalance these artifacts, isolating the true biological signal related to tumor aggressiveness

Inventive Principle:
Principle #8Anti-weight (Counterweight)

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 allows for the precise stratification of DCIS lesions, enabling the precise characterization of ductal carcinoma in situ (DCIS) and the precise characterization of ductal carcinoma in situ (DCIS) lesions, thereby improving standardization and efficacy.

Implementation Method 1

Each biomarker to be quantitated is labeled with a separately optically-detectable label. In some embodiments, the optically-detectable labels are fluorescent dyes.

Methodology Applied
Scientific EffectFluorescence: Fluorescence

Implementation Method 2

quantitating the level of the first and second biomarkers by detecting the first and second detection reagents using fluorescence imaging microscopy

Methodology Applied
Scientific EffectOptical detection: Light

Data Source

PatentEP3464641B1Biomarker ratio imaging microscopy
Publication Date: 2026.03.11 THE RGT UNIV OF MICHIGAN
  • EP3464641B1 patent drawingFigure 1A~1C
  • EP3464641B1 patent drawingFigure 1D~1F
  • EP3464641B1 patent drawingFigure 2A~2E

AI summary

Provided herein are methods and systems for the analysis of biomarkers, and methods of providing diagnoses and/or prognoses therewith. In particular, methods and systems for performing biomarker ratio imaging microscopy (BRIM) are provided, as well as methods of using BRIM for the analysis of biomarker pairs (e.g., CD44/CD24, N-cadherin/E-cadherin, CD74/CD59, etc.) diagnosis and/or prognosis of cancer (e.g., ductal carcinoma in situ).