Automated Biomarker Quantification in Tissue Samples

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Solution Overview

Problem

Traditional biomarker assessment methods, such as cytochemical and immunohistochemical techniques, are subjective and lack standardization, leading to significant variability in lab-to-lab, machine-to-machine, and operator-to-operator results, compromising the reproducibility of biomarker expression analysis in tissue samples.

Innovation Solution

An automated system for reproducible biomarker quantification in tissue samples using a standardized optical system with normalized light intensity and automatic exposure adjustment, enabling unsupervised analysis and differentiation of data signals from cellular compartments, with confidence intervals and optimal dynamic range optimization to minimize variability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional cytochemical and immunohistochemical techniques are used for biomarker assessment, then the methods can be performed with existing equipment and procedures, but the results show significant variability between operators, machines, and laboratories

Engineering Contradiction:
Improvereproducibility of biomarker expression analysisVSAvoidsubjectivity of traditional methods
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent replaces manual, operator-dependent visual assessment with automated digital image analysis systems. The system captures images of tissue sections and uses computer algorithms to objectively quantify biomarker expression, eliminating operator subjectivity while maintaining ease of operation through automated processing.

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

Solution Approach 2:

The patent transforms subjective visual assessment into objective quantitative parameters by measuring pixel intensity values, optical density, and other numerical metrics from digital images. This parameter transformation enables reproducible biomarker quantification across different laboratories and operators.

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If traditional IHC testing is performed at local laboratories, then the testing can be conducted locally with immediate results, but there is up to 20% error between local and central lab testing

Engineering Contradiction:
Improveconsistency of biomarker quantificationVSAvoidcomplexity of standardized optical system
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent creates a universal digital image analysis system that can be deployed across multiple laboratories with standardized protocols. The system processes images from different sources and conditions through consistent algorithms, enabling centralized quality control while allowing local testing capabilities.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Reliability

If automated digital image analysis is implemented for biomarker quantification, then operator-independent analysis and assay result reproducibility are enhanced, but the system requires standardized optical equipment and normalized lighting conditions

Engineering Contradiction:
Improveoperator-independent analysisVSAvoidstandardized optical system requirements
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent incorporates preliminary standardization steps including normalization of light intensity, calibration of optical paths, and optimization of exposure settings before actual biomarker quantification. These preliminary actions ensure that the automated analysis operates under controlled conditions, reducing the impact of equipment variability.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentEP2335221B8Reproducible quantification of biomarker expression
Publication Date: 2016.05.25 NOVARTIS AG

AI summary

A method is described for the reproducible quantification of biomarker expression, including biomarker expression in a tissue sample. Methods and systems are described whereby reproducible scores for biomarker expression are obtained independent of instrument, its location, or operator.