Quantitative Algorithm for Endometriosis Diagnosis
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Solution Overview
Problem
Endometriosis diagnosis is challenging due to delayed symptom recognition and the invasiveness of current diagnostic methods, such as laparoscopy, which is unsuitable for repeated monitoring or relapse assessment.
Innovation Solution
A method using specific microRNAs (miRNAs) like miR-18, miR-125, miR-342, and miR-451 to develop a quantitative algorithm for diagnosing, staging, and monitoring endometriosis through non-invasive means, such as analyzing blood, serum, or saliva samples, and determining treatment approaches.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If laparoscopy is used as the gold standard for endometriosis diagnosis, then diagnostic accuracy is improved, but patient invasiveness and post-operative pain increase
Solution Approach 1:
The patent replaces the mechanical surgical procedure of laparoscopy with a biochemical diagnostic system using microRNA analysis. The algorithm processes molecular biomarkers (microRNAs) from patient samples to diagnose endometriosis, substituting the mechanical invasive procedure with a non-invasive molecular detection approach that maintains diagnostic accuracy while eliminating surgical risks
Solution Approach 2:
The patent introduces microRNA biomarkers as intermediary molecules that mediate between the disease state and diagnostic detection. These molecular intermediaries provide information about endometriosis presence and severity without requiring direct visual inspection through surgery, allowing indirect but accurate diagnosis through biochemical analysis
2Reliability
If laparoscopy is used for diagnosis, then disease confirmation is achieved, but repeated monitoring and relapse assessment become unsuitable
Solution Approach 1:
The patent creates a diagnostic system that patients can utilize repeatedly without cumulative harm. The non-invasive microRNA analysis allows patients to undergo monitoring at any time without the recovery period required after laparoscopy, enabling continuous self-monitoring and repeated assessment of disease status or relapse
Solution Approach 2:
The patent transforms the static, one-time diagnostic approach of laparoscopy into a dynamic, repeatable monitoring system. The algorithm-based microRNA analysis can be performed multiple times with varying disease states, allowing the diagnostic system to adapt to different time points and disease progression stages without degradation of patient condition
3Ease of operation
If common symptoms like pelvic pain and dysmenorrhea are interpreted as extreme menstruation variants, then misdiagnosis occurs, but early detection is delayed
Solution Approach 1:
The patent changes the diagnostic parameter from subjective symptom interpretation to objective molecular measurement. Instead of relying on clinicians to interpret pain severity as normal menstruation variants, the system measures specific microRNA expression levels that objectively indicate endometriosis, providing a clear threshold-based diagnosis that eliminates interpretation ambiguity and accelerates detection
Data Source
AI summary
Disclosed herein are methods for developing and using quantitative algorithms, cutoff points, and numerical scores based upon the expression level of at least one miRNA that is associated with endometriosis.