Multiplexed Biomarker Assay for HCC Diagnosis
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Solution Overview
Problem
Current diagnostic methods for liver disorders, particularly hepatocellular carcinoma (HCC), lack specificity and sensitivity, relying on biomarkers like AFP which are not universally effective, and other markers such as CA 125, CEA, and CA 19-9 are not recognized for HCC diagnosis, leading to challenges in early detection and targeted therapy.
Innovation Solution
A method involving the measurement of biomarkers CEA, CA 125, and CA 19-9, alone or in combination with additional markers like AFP, OPN, MMP-9, E-cadherin, and erbB2, to diagnose and monitor HCC and cirrhosis, using multiplexed assays for improved specificity and sensitivity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If AFP is used as the primary biomarker for HCC diagnosis, then the diagnostic method is simple and widely accepted, but the specificity and sensitivity are insufficient due to false positives from benign conditions and false negatives from AFP-non-secreting tumors
Solution Approach 1:
The patent combines multiple biomarkers (AFP, CA 125, CEA, CA 19-9, OPN, MMP-9, E-cadherin, erbB2) into a single multiplexed assay system that measures all markers simultaneously in one test, resolving the contradiction by improving diagnostic accuracy through marker combination while avoiding the complexity increase that would result from running separate assays for each marker
Solution Approach 2:
The multiplexed assay system serves multiple diagnostic functions simultaneously - it can detect HCC, distinguish HCC from cirrhosis, identify treatment responders, and monitor disease progression all within a single assay platform, making the system universally applicable to various diagnostic needs without requiring multiple separate tests
2Reliability
If multiple biomarkers are measured separately to improve diagnostic accuracy, then the specificity and sensitivity increase, but the assay complexity and time required for diagnosis increase
Solution Approach 1:
The patent merges the measurement of multiple biomarkers (AFP, CA 125, CEA, CA 19-9, OPN, MMP-9, E-cadherin, erbB2) into a single multiplexed assay that detects all markers simultaneously, achieving high specificity through multi-marker analysis while avoiding the time and complexity penalties of running separate assays for each marker
Solution Approach 2:
The multiplexed assay enables continuous monitoring of multiple biomarkers in parallel, allowing for ongoing detection of HCC, cirrhosis progression, and treatment response without the interruption and repeated sampling required by sequential separate assays, thus maintaining continuous diagnostic action
3Measurement precision
If traditional single biomarker assays are used, then the test is fast and cost-effective, but the ability to distinguish HCC from cirrhosis and detect early stages is limited
Solution Approach 1:
The patent combines multiple biomarkers into a single multiplexed assay that measures all markers simultaneously in one test, achieving high detection precision for distinguishing HCC from cirrhosis and detecting early stages while avoiding the time loss that would result from running multiple separate assays sequentially
Solution Approach 2:
The multiplexed assay performs preliminary detection of multiple biomarkers in a single test, allowing the system to identify HCC cases, assess cirrhosis severity, and determine treatment responsiveness all in advance within one diagnostic action, eliminating the need for subsequent sequential testing
Data Source
AI summary
The present invention relates to methods of diagnosing a liver disorder in a patient, as well as methods of monitoring the progression of a liver disorder and/or methods of monitoring a treatment protocol of a therapeutic agent or a chemotherapeutic regimen. The invention also relates to assay methods used in connection with the diagnostic methods described herein.