Universal Biomarker Arrays for Early Disease Localization
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Solution Overview
Problem
Current diagnostic methods lack the sensitivity, accuracy, and speed to detect and localize early disease processes across various tissues and diseases, particularly in clinical settings, as they often require invasive procedures or have resolution limitations, making it difficult to identify small changes in tissue architecture.
Innovation Solution
An ensemble of top-performing quantitative parameter arrays, including spatial entropy, bin, and quartile arrays, are calculated from digital tissue images to create a universal biomarker array, which is analyzed using AI/ML for early disease diagnosis and localization, providing real-time feedback.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If specialized diagnostic methods (laboratory tests, imaging, endoscopy) are used for each tissue and disease type, then diagnostic accuracy for specific conditions is improved, but device complexity and loss of time increase due to multiple specialized procedures
Solution Approach 1:
The patent creates a universal diagnostic platform that combines multiple specialized diagnostic capabilities into a single integrated system. The universal biomarker array can detect various disease states across different tissue types using the same imaging and analysis infrastructure, eliminating the need for separate specialized tests for each condition while maintaining diagnostic accuracy.
Solution Approach 2:
The diagnostic system segments disease detection into distinct biomarker arrays (pattern array, distance array, morphology array, spatial entropy array, bin array, quartile array), each analyzing specific tissue characteristics. This segmentation allows the system to handle diverse disease types through modular analysis while maintaining a unified diagnostic platform.
2Measurement precision
If tissue biopsies and destructive analyses are used to determine early disease processes, then measurement precision is improved, but object-affected harmful factors increase due to invasive procedures
Solution Approach 1:
The patent creates a digital copy of tissue architecture through high-resolution imaging that captures cellular-level details without physically removing tissue. The universal biomarker array analyzes these digital representations to detect early disease processes, replacing invasive biopsies with non-invasive imaging-based detection while maintaining measurement precision.
Solution Approach 2:
The patent introduces high-resolution digital imaging as an intermediary between the tissue and the diagnostic analysis. Instead of directly removing and analyzing tissue through biopsies, the system uses imaging to capture tissue architecture and then applies the universal biomarker array to detect disease, eliminating the need for destructive sampling.
3Ease of operation
If clinical imaging tests are used to locate diseases, then localization capability is improved, but measurement precision deteriorates due to resolution limitations that prevent visualization of early disease processes
Solution Approach 1:
The patent replaces conventional clinical imaging modalities with a specialized high-resolution imaging system capable of capturing cellular-level details. This substitution enables the system to achieve both localization capability and high measurement precision by visualizing early disease processes at the cellular level rather than relying on lower-resolution macroscopic imaging.
Solution Approach 2:
The patent transitions from macroscopic imaging to microscopic cellular-level imaging, adding a new dimension of resolution. This dimensional change enables the detection of early disease processes that are invisible to conventional imaging while maintaining localization capability through the universal biomarker array's ability to identify specific tissue regions.
4Productivity
If AI/ML analysis of universal biomarker arrays is implemented, then productivity and speed of diagnosis are improved, but device complexity increases due to computational requirements
Solution Approach 1:
The patent implements self-service through automated AI/ML analysis that processes the universal biomarker array independently without requiring manual intervention. The system automatically analyzes the six arrays (pattern, distance, morphology, spatial entropy, bin, quartile) to generate diagnostic results, significantly increasing productivity while the computational complexity is managed through optimized algorithms.
Data Source
AI summary
A universal biomarker array enables the diagnosis and localization of earlier-than-now recognizable disease states as well as increasing the accuracy of diagnosing states of disease(s) in general. The universal biomarker array is formed of a range of mathematical parameters computed from digital tissue images showing tissue details at a cellular level. The universal biomarker array includes one or more novel parameter arrays (namely, a spatial entropy array, a bin array, and/or a quartile array) in combination with one or more state-of-the-art parameter arrays (namely, a pattern array, a distance array, and/or a morphology array) and/or in combination with one or more other parameters. An AI/ML system can be used to analyze the universal biomarker array relative to database-based reference data for early diagnosis and localization of disease processes.


