Automated Tissue Mask Projection for Multi-Assay Biomarker Analysis

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Solution Overview

Problem

Current methods for multiplex immunohistochemistry (IHC) staining and imaging are inefficient in querying multiple biomarkers, particularly in cases where contextual and anatomical information is crucial, such as in tumor heterogeneity, leading to incomplete analysis and suboptimal therapy selection due to labor-intensive and error-prone manual outlining of tissue regions.

Innovation Solution

The system and method for receiving assay information and projecting anatomical data onto IHC assays to generate masks, allowing for systematic and quantitative analysis of multiple biomarkers within specific anatomical regions, enabling comprehensive multi-assay analysis by correlating features of interest with anatomical context.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If manual outlining of tissue regions is used to analyze multiple biomarkers, then anatomical context can be considered, but the process becomes labor-intensive and error-prone

Engineering Contradiction:
Improveanalysis accuracyVSAvoidanalysis efficiency
Core Design Contradiction:
Measurement precisionVSProductivity

Solution Approach 1:

The patent replaces manual mechanical outlining with automated computational image processing and machine learning algorithms. The system automatically segments tissue regions, identifies anatomical structures, and queries biomarker distributions without human intervention, thereby eliminating labor-intensive manual operations while maintaining or improving analysis accuracy through consistent algorithmic application.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The system enables self-service automation where the computational pipeline independently performs region segmentation, biomarker quantification, and result generation. The automated workflow processes multiple biomarkers simultaneously across defined anatomical regions without requiring manual re-outlining for each query, significantly improving productivity while preserving measurement precision through standardized automated procedures.

Inventive Principle:
Principle #25Self-service

2Loss of information

If multiple biomarkers are queried in multiplex assays, then comprehensive tissue analysis is achieved, but the complexity of processing multiple channels and correlating anatomical information increases

Engineering Contradiction:
Improvecontextual information retentionVSAvoiddata processing complexity
Core Design Contradiction:
Loss of informationVSDevice complexity

Solution Approach 1:

The patent applies segmentation by dividing the complex multiplex assay data into manageable components: anatomical region segmentation separates different tissue structures, while biomarker channel segmentation processes each marker independently. This modular segmentation allows comprehensive multi-biomarker analysis to be conducted systematically, reducing processing complexity by handling multiple channels through structured division rather than monolithic processing.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system introduces computational intermediaries in the form of automated image processing algorithms and data integration layers that mediate between raw multiplex assay data and final analysis results. These intermediaries standardize the processing of multiple biomarker channels, correlate anatomical information systematically, and reduce overall system complexity by providing structured transformation steps between input data and output insights.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Productivity

If automated image processing methods are used for color separation and spectral unmixing, then analysis efficiency improves, but the precision in determining local concentration of stains may be compromised

Engineering Contradiction:
Improveprocessing speedVSAvoidstain concentration accuracy
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The patent employs advanced automated image processing techniques including spectral unmixing algorithms and machine learning-based stain deconvolution that replace manual color separation methods. These computational approaches process multiple spectral channels simultaneously to determine local stain concentrations with high precision, maintaining measurement accuracy while achieving automated processing speeds that greatly exceed manual analysis capabilities.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The system utilizes parameter changes in the form of spectral parameter analysis and multi-channel intensity variations to resolve stain concentrations. By analyzing changes in spectral parameters across multiple channels and applying mathematical unmixing models, the system accurately determines local concentrations of multiple stains simultaneously, preserving measurement precision while enabling automated high-speed processing of multiplex assay data.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS10650221B2Systems and methods for comprehensive multi-assay tissue analysis
Publication Date: 2020.05.12 VENTANA MEDICAL SYSTEMS INC
  • US10650221B2 patent drawing
  • US10650221B2 patent drawing
  • US10650221B2 patent drawing

AI summary

The subject disclosure presents systems and methods for receiving a plurality of assay information along with a query for one or more features of interest, and projecting anatomical information from an anatomical assay onto a staining assay, for example an immunohistochemical (IHC) assay that is commonly registered with the anatomical assay, to locate or determine features appropriate for analysis. The anatomical information may be used to generate a mask that is projected on one or more commonly registered staining assays. A location of the feature of interest in the staining assay may be correlated with the anatomical context provided by the mask, with any features of interest that match the anatomical mask being selected or indicated as appropriate for analysis.