Multi-targeted liver fibrosis diagnostic test
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Solution Overview
Problem
Current non-invasive diagnostic tests for liver fibrosis and cirrhosis are limited by their single-targeted approach, which reduces accuracy for diagnosing various stages of fibrosis, including cirrhosis, and lacks a comprehensive method to assess the risk of death or liver-related events.
Innovation Solution
A multi-targeted diagnostic method involving at least 3 binary logistic regressions on various variables, followed by a multiple linear regression to generate a comprehensive score for assessing liver lesion severity and risk, incorporating biomarkers, clinical markers, and physical data from methods like Vibration Controlled Transient Elastography.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If single-targeted non-invasive tests are used to diagnose liver fibrosis, then the test implementation is simple, but the diagnostic accuracy for various stages of fibrosis including cirrhosis is reduced
Solution Approach 1:
The patent creates a multi-targeted test that simultaneously evaluates multiple fibrosis stages (F≥1, F≥2, F≥3, and cirrhosis) using a single comprehensive assay. This multi-functional test design allows clinicians to assess various diagnostic targets in one test implementation, resolving the contradiction by maintaining simplicity while improving diagnostic accuracy across all fibrosis stages.
2Device complexity
If single-targeted tests are used to assess liver fibrosis, then the test design is straightforward, but the ability to assess risk of death or liver-related events is lacking
Solution Approach 1:
The patent merges diagnostic and prognostic functions into a single multi-targeted test. By combining the assessment of multiple fibrosis stages with prognostic evaluation for death and liver-related events, the test design comprehensively addresses both diagnostic accuracy and prognostic reliability without requiring separate complex testing protocols.
3Measurement precision
If blood tests are calibrated for a precise diagnostic target like significant fibrosis, then the test performance for that target is optimized, but the performance for distant targets like cirrhosis becomes less accurate
Solution Approach 1:
The patent develops a universal multi-targeted test that maintains high performance across all fibrosis stages simultaneously. Rather than calibrating for a single target, the test is designed to accurately diagnose F≥1, F≥2, F≥3, and cirrhosis, making it adaptable to various diagnostic needs while preserving measurement precision for each specific stage.
Data Source
AI summary
Disclosed is a non-invasive method for assessing in a subject the presence and severity of a liver lesion, or the risk of death or liver-related events, including: 1) performing at least three binary logistic regressions on at least one variable, performed on the same variable(s) but each directed to a different single diagnostic target, thereby obtaining at least three scores; 2) combining the scores from step 1) in a multiple linear regression to obtain a new multi-targeted score; 3) optionally sorting the multi-targeted score obtained in step 2) in a classification of liver lesion stages or grades, thereby determining to which liver lesion stage or grade the subject belongs based on his/her multi-targeted score. Also disclosed is a single multi-targeted non-invasive test obtained by the combination of single-targeted non-invasive tests providing a unique score and a unique classification with improved accuracy compared to single-targeted diagnostic tests.