Radiosensitivity Gene Expression Analysis Kit for Breast Cancer Subtyping

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Solution Overview

Problem

Current adjuvant radiotherapy approaches for breast cancer often result in overtreatment of patients who are unlikely to recur and under-treatment of those who may develop local recurrence, highlighting the need for a method to assess radiosensitivity to personalize treatment strategies.

Innovation Solution

A kit and method for analyzing the expression of specific genes indicative of radiosensitivity and radioresistance in breast cancer cells, using reagents such as antibodies, aptamers, and nucleic acid probes to determine a patient's treatment course, including the use of computer-based analysis to generate a radiosensitivity assessment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If standard adjuvant radiotherapy is applied to all breast cancer patients, then treatment coverage is maximized, but treatment precision deteriorates due to overtreatment of low-risk patients and undertreatment of high-risk patients

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidradiosensitivity assessment accuracy
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The patent segments the breast cancer patient population into distinct radiosensitivity subgroups (radio-sensitive, radio-intermediate, radio-resistant) based on gene expression profiles. This segmentation allows for personalized treatment recommendations, preventing overtreatment of radio-sensitive patients and undertreatment of radio-resistant patients, thereby resolving the contradiction between treatment coverage and treatment precision.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent changes the parameter of treatment decision-making from uniform clinical guidelines to personalized gene expression-based classification. By measuring expression levels of specific genes (such as ATM, BRCA1, BRCA2, RAD51, and other DNA repair-related genes) and calculating a radiosensitivity score, the system enables precise differentiation of patient responses to radiation therapy, improving both reliability and measurement precision.

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If gene expression analysis of multiple markers is performed, then treatment selection accuracy is improved, but diagnostic complexity increases

Engineering Contradiction:
Improveradiosensitivity prediction accuracyVSAvoidkit composition complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent segments the diagnostic process into distinct functional modules: sample preparation, gene expression measurement (using various techniques such as qRT-PCR, microarray, or RNA sequencing), data normalization, radiosensitivity score calculation, and treatment recommendation. This modular segmentation manages complexity by organizing multiple gene analyses into a systematic workflow, making the diagnostic process more tractable despite analyzing multiple gene markers.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent employs universal data processing algorithms and scoring systems that can accommodate multiple gene markers and various measurement techniques. The radiosensitivity scoring system is designed to integrate data from different genes (DNA repair genes, cell cycle genes, apoptosis genes) using a unified computational framework, thereby managing complexity through multi-functionality rather than requiring separate systems for each gene or technique.

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

Data Source

PatentEP3677694B1Compositions and methods for the analysis of radiosensitivity
Publication Date: 2022.07.20 THE RGT UNIV OF MICHIGAN
  • EP3677694B1 patent drawingFigure 1A~1B
  • EP3677694B1 patent drawingFigure 2
  • EP3677694B1 patent drawingFigure 3

AI summary

Provided herein are compositions and methods for the analysis of radiosensitivity, to, for example, assess the efficacy or select therapeutic agents for the treatment and/or diagnosis of cancer.