Thyroid Nodule Classification via MicroRNA Expression Correlation
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Solution Overview
Problem
Current methods for classifying indeterminate thyroid nodules lack specificity, sensitivity, accessibility, and are costly, often requiring new FNAP procedures and resulting in unnecessary surgeries due to the inability to accurately differentiate between benign and malignant lesions using existing molecular tests.
Innovation Solution
A method and kit utilizing microRNA expression levels, specifically measuring and correlating normalizing and discriminating microRNAs such as dme-miR-7, hsa-let-7a, and hsa-miR-204, to improve the classification of thyroid nodules, allowing for accurate differentiation between benign and malignant lesions using existing FNAP samples without the need for additional procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If molecular tests using gene mutations (BRAF, TERT, RAS, TP53) are used to identify malignancy, then specificity and positive predictive value are improved, but the ability to avoid unnecessary surgeries is limited
Solution Approach 1:
The patent combines rule-in tests (gene mutation analysis) and rule-out tests (microRNA expression profiling) into a single integrated diagnostic approach. By analyzing both malignant markers and benign markers simultaneously, the method achieves high specificity while also effectively identifying benign cases that can avoid surgery, thus resolving the contradiction between specificity and reducing unnecessary surgeries.
Solution Approach 2:
The diagnostic method uses a composite molecular profile comprising multiple types of molecular markers (gene mutations and microRNA expressions) rather than relying on a single marker type. This composite approach allows the test to capture both malignant and benign features, improving both specificity and the ability to avoid unnecessary surgeries by providing a more comprehensive classification.
2Reliability
If new FNAP procedures are performed to obtain samples for molecular testing, then sample quality is improved, but patient burden and procedural complexity increase
Solution Approach 1:
The method enables the existing FNAP sample to serve multiple purposes: it is used for both the initial cytological evaluation and for subsequent molecular testing (both gene mutation analysis and microRNA expression profiling). This self-service approach eliminates the need for additional FNAP procedures, reducing procedural complexity while maintaining sample quality.
Solution Approach 2:
The FNAP sample is designed to be universally applicable for multiple diagnostic purposes. The same sample material can be used for cytological assessment, gene mutation testing, and microRNA expression analysis, making the diagnostic process more efficient and reducing the need for additional invasive procedures.
3Ease of operation
If traditional cytological evaluation is used for indeterminate nodules, then diagnostic simplicity is maintained, but accuracy and ability to differentiate benign from malignant lesions deteriorate
Solution Approach 1:
The patent replaces the purely mechanical/cytological evaluation method with a molecular-based diagnostic system. By substituting cellular morphology assessment with molecular marker analysis (gene mutations and microRNA expressions), the method achieves superior classification accuracy while maintaining operational simplicity through standardized molecular testing protocols.
Solution Approach 2:
The diagnostic approach shifts from evaluating morphological parameters (cell shape, size, arrangement) to measuring molecular parameters (gene mutation status, microRNA expression levels). This parameter change enables more accurate differentiation between benign and malignant indeterminate nodules while providing objective, quantifiable diagnostic criteria.
4Reliability
If surgical intervention is performed on all indeterminate nodules, then risk of missing malignancy is reduced, but unnecessary surgeries and associated complications increase
Solution Approach 1:
The patent performs preliminary molecular classification before surgical intervention. By conducting both rule-in and rule-out molecular tests on indeterminate nodules, the method pre-identifies which lesions are likely malignant and which are likely benign, allowing clinicians to avoid unnecessary surgeries on benign cases while maintaining high detection of malignancies, thus reducing surgical complications.
Solution Approach 2:
The molecular testing provides feedback that guides clinical decision-making. The results of gene mutation analysis and microRNA expression profiling feed back into the diagnostic process, enabling clinicians to make informed decisions about surgical necessity. This feedback mechanism reduces unnecessary surgeries while maintaining reliable malignancy detection.
Data Source
AI summary
A method and kit for the classification of thyroid nodules that allows a more precise identification of the type of thyroid nodule as being malignant, benign or subclassifications, including at least one step of measuring the expression level of at least one normalizing microRNA and at least one discriminating microRNA and at least one step of correlation between the expression level of at least one normalizing microRNA and at least one discriminating microRNA.