Hepatic Fibrosis Biomarker Panel for Non-Invasive Early Detection
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Solution Overview
Problem
Current methods for diagnosing hepatic fibrosis, particularly cholestatic-induced hepatic fibrosis, are invasive, unreliable, and often detect the condition at an advanced stage, lacking sensitivity and specificity for early detection.
Innovation Solution
A method involving the measurement of specific protein levels in biological samples using a panel of biomarkers such as Osteoprotegerin, JAM-A, RANTES, sTNF RI, IL20, GITR, CD36/SRB3, and others, identified through an algorithmic analysis in animal models, to enable early and non-invasive diagnosis of hepatic fibrosis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If liver biopsy is used for diagnosis, then diagnostic reliability is improved, but invasiveness and patient risk increase
Solution Approach 1:
The patent uses serum or plasma as an intermediary medium to detect fibrosis biomarkers indirectly, replacing the direct invasive liver biopsy procedure. This allows diagnosis through non-invasive blood sampling while maintaining diagnostic reliability through specific biomarker detection.
Solution Approach 2:
The patent replaces the mechanical invasive procedure of liver biopsy with a biochemical analysis system that detects fibrosis markers in blood samples, eliminating the need for physical tissue extraction while maintaining diagnostic capability.
2Measurement precision
If liver biopsy is performed, then diagnostic accuracy is improved, but timing is delayed until advanced stage
Solution Approach 1:
The patent enables preliminary detection of fibrosis at early stages through proactive monitoring of biomarkers in blood samples, allowing diagnosis before advanced tissue damage occurs. This preliminary action facilitates early intervention while maintaining high diagnostic accuracy through specific biomarker detection.
3Object-affected harmful factors
If Fibroscan is used, then non-invasiveness is improved, but diagnostic specificity and early detection capability deteriorate
Solution Approach 1:
The patent uses serum or plasma as an intermediary to detect specific fibrosis biomarkers, providing both non-invasive sampling and high diagnostic specificity. This biochemical approach allows early detection of fibrosis etiology while maintaining non-invasive characteristics through blood sampling.
Solution Approach 2:
The patent detects changes in biomarker parameters (concentration levels of specific proteins) in blood samples to identify fibrosis early in its development. This parameter-based detection enables early diagnosis with high specificity while remaining non-invasive through blood sampling.
4Ease of operation
If indirect biomarkers are used, then ease of measurement is improved, but diagnostic reliability for early fibrosis deteriorates
Solution Approach 1:
The patent uses serum or plasma as an intermediary medium that contains specific fibrosis biomarkers, enabling easy non-invasive sampling while maintaining high diagnostic reliability through direct detection of fibrosis-related proteins rather than indirect inference.
Solution Approach 2:
The patent replaces indirect inference-based measurement with direct biochemical detection of fibrosis biomarkers in blood samples, maintaining ease of measurement through simple blood sampling while significantly improving diagnostic reliability for early fibrosis detection.
Data Source
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AI summary
The present invention relates to a method to perform an in vitro diagnosis of hepatic fibrosis, performed on samples isolated from the subject to be subjected to said diagnosis. Furthermore, the present invention relates to a kit that allows to perform such a method of in vitro diagnosis and the use of biomarker panels in the method and kit of the invention.