Automated In Situ Hybridization Analysis for Objective HER2 Scoring
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Solution Overview
Problem
Existing methods for analyzing biological samples, such as IHC and ISH, are subjective and time-consuming, particularly in determining genetic aberrations like HER2 status in cancer cells, as they rely heavily on manual cell selection and analysis of limited cell samples.
Innovation Solution
An automated system and method for analyzing digital images of biological samples that automatically selects cells meeting protein biomarker criteria, registers images to a common coordinate system, identifies nucleic acid biomarker signals, and assesses genetic aberrations by calculating ratios of these signals, providing an objective and efficient analysis of genetic aberrations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If manual cell selection and analysis methods are used, then analysis can be performed with simple equipment, but the analysis is subjective and time-consuming with limited cell samples
Solution Approach 1:
The patent replaces manual mechanical cell selection with an automated computer-based system that uses image processing algorithms to automatically identify and select cells based on staining patterns. The system processes digital images of tissue sections and automatically detects cells meeting predetermined criteria, eliminating the need for manual microscopic examination and selection.
Solution Approach 2:
The system enables self-service analysis by automatically performing cell selection, image registration, signal identification, and genetic aberration assessment without requiring continuous human intervention. The automated workflow processes multiple images and generates analysis results independently, allowing the system to serve itself through algorithmic decision-making.
2Measurement precision
If manual cell selection is used, then equipment complexity is low, but measurement precision and objectivity are reduced
Solution Approach 1:
The patent segments the analysis process into distinct automated modules: cell identification based on protein biomarker staining, image registration to common coordinate systems, nucleic acid biomarker signal identification, and genetic aberration assessment. Each module operates independently with specific algorithms, allowing complex analysis to be broken down into manageable automated components that can be executed systematically.
Solution Approach 2:
The system introduces digital image processing algorithms as intermediaries between the physical tissue sample and the final analysis results. These algorithms act as mediators that automatically interpret staining patterns, register images, identify signals, and calculate genetic aberrations, providing objective measurement precision without requiring direct manual observation.
3Reliability
If limited cell samples are analyzed, then analysis is faster with fewer cells, but the assessment robustness is reduced
Solution Approach 1:
The patent implements continuous automated analysis that can process an extended number of cells without interruption. The system automatically transitions from one cell to the next, maintaining continuous operation through algorithmic cell selection and analysis. This continuous action enables robust assessment of numerous cells while maintaining high productivity through automated workflows that eliminate manual processing bottlenecks.
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
The system allows for a more robust assessment of genetic aberrations by analyzing a larger number of cells, reducing subjectivity, and enabling quicker and more accurate determination of HER2 status, thereby improving patient care and treatment decisions.
Implementation Method 1
ISH employs labeled DNA or RNA probe molecules that are anti-sense to a target gene sequence or transcript to detect or localize targeted nucleic acid target genes within a cell or tissue sample. ISH is performed by exposing a cell or tissue sample immobilized on a glass slide to a labeled nucleic acid probe which is capable of specifically hybridizing to a given target gene in the cell or tissue sample.
Data Source
AI summary
The present disclosure provides for image processing systems and methods for analyzing digital images of biological samples stained for the presence of protein and/or nucleic acid biomarkers and detecting and quantifying signals corresponding to one or more biomarkers. The present disclosure also provides systems and methods for the clinical interpretation of dual ISH slides where the cells to score are selected (e.g. by using one or more cell detection and identification algorithms. By detecting, identifying, and selecting cells for assessment, it is believed that subjectivity is reduced or eliminated. The systems and methods also allow for an increased number of cells to be considered for scoring as compared with manual dot counting methods, thereby increasing detection sensitivity, ultimately enabling improved patient care and treatment.