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Evidence

Validation

A retrospective evaluation of the diagnostic performance of an interdependent pairwise microRNA expression analysis with a mutation panel in indeterminate thyroid nodules. Finkelstein SD, 2022

The addition of genetic analysis to the evaluation of thyroid FNA samples improves diagnostic accuracy of indeterminate thyroid nodules. This study evaluated the ability of interdependent pairwise microRNA expression analysis to further improve the diagnostic performance of a multiplatform test (MPTX), which for this study will be referred to as MPTXv1.

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Analytical and clinical validation of pairwise microRNA expression analysis to identify medullary thyroid cancer in thyroid fine‐needle aspiration samples. Ciarletto AM, 2020

This study demonstrated the analytical and clinical validity of a pairwise microRNA (miRNA) analysis for the detection of medullary thyroid cancer (MTC) using ThyraMIR® Thyroid miRNA Classifier. miRNA classification was …

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Multiplatform Molecular Test Performance in Indeterminate Thyroid Nodules. Lupo MA, 2020

Multicenter, retrospective, blinded validation study of 309 subjects with indeterminate thyroid nodules (Bethesda III, IV, or V) and corresponding surgical histology. Gold-standard unanimous consensus histopathology diagnosis (n=197) among three pathologists …

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Development and Analytical Validation of an Expanded Mutation Detection Panel for Next-Generation Sequencing of Thyroid Nodule Aspirates. Ablordeppey KK, 2019

This paper discusses the development of an expanded mutation panel (ThyGeNEXT®). Additionally, it demonstrates the analytical validation of the expanded NGS panel test and compares analytical characteristics of ThyGeNEXT to the …

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Molecular Testing for miRNA, mRNA, and DNA on Fine-Needle Aspiration Improves the Preoperative Diagnosis of Thyroid Nodules With Indeterminate Cytology. Labourier E, 2015

This multicenter prospective observational study evaluated the use of a mutation detection and miRNA expression algorithm to improve the diagnostic yield of molecular testing for thyroid nodules. 109 thyroid nodules …

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Presented Posters

Clinical Utility of a Mutation Panel Used in Combination With an Expanded microRNA Risk Classifier in Indeterminate Thyroid Nodules: A Large Real-world Observational Study

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Two Novel microRNA Pairwise Expression Profilers Complement Multiplatform Molecular Testing (MPTX), Providing More Accurate Diagnosis of Indeterminate Thyroid Nodules

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Development and Validation of a Molecular Diagnostic Test for Medullary Thyroid Carcinoma Using NGS Mutation Detection and microRNA Expression Profiling

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Molecular Analysis Of Thyroid Malignancy Using FNA Cytology Smears by the Combined ThyGenX NGS and ThyraMIR™ miRNA Classifier Test: A Prospective Study

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Comprehensive Genotyping for Somatic Variation and microRNA Expression Accurately Predicts Malignancy Risk of Thyroid Nodules

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Utility

Preoperative molecular testing in thyroid nodules with Bethesda VI cytology: Clinical experience and review of the literature. Labourier E, 2020

A systematic review of the literature was conducted in addition to an analysis of molecular data generated from fine needle aspiration biopsies (FNAB). Twenty-one studies from 12 countries involving 2036 preoperative …

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Clinical Performance of Multiplatform Mutation Panel and microRNA Risk Classifier in Indeterminate Thyroid Nodules

This study evaluated the clinical performance of ThyGeNEXT®, an expanded mutation panel of strong and weak drivers of oncogenic changes, used in combination with ThyraMIR®, a microRNA classifier for the …

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Incremental utility of expanded mutation panel when used in combination with microRNA classification in indeterminate thyroid nodules. Jackson S, 2019

In this study, molecular results from 12,993 consecutive patient samples were reviewed for cases that either underwent testing with a focused mutation panel (n=8619) or an expanded mutation panel (ThyGeNEXT®, …

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Clinical impact of testing for mutations and microRNAs in thyroid nodules. Sistrunk JW, 2019

This multicenter, observational, real-world clinical experience study examined the likelihood of patients with indeterminate thyroid nodules to undergo surgery or have malignant outcomes based on multiplatform combination mutation and microRNA …

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The utility of combined mutation analysis and microRNA classification in reclassifying cancer risk of cytologically indeterminate thyroid nodules. Banizs AB, 2019

In this study, real-world clinical results of molecular testing for indeterminate thyroid nodules were analyzed based upon Bethesda categorization, mutation analysis, and microRNA classifier results and were correlated to show …

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Utility and Cost-effectiveness of Molecular Testing in Thyroid Nodules With Indeterminate Cytology, Labourier E, 2016.

The purpose of this study was to determine the health outcome benefits and cost-effectiveness of molecular testing in nodules with AUS/FLUS or FN/SFN cytology. The initial diagnosis and treatment of …

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Presented Posters

Show Me The Money! Institutional Experience with Molecular Testing of Thyroid Nodules

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Outcomes of Molecular Testing in Cytologically Indeterminate Thyroid Nodules

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Correlation Between Mutations in Malignant Thyroid Nodules and Aggressive Tumor Behavior

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The utility of combined mutations and microRNA expression profiling in assessing cancer risk in thyroid nodules

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Molecular Analysis of Non-Diagnostic (B-I) Thyroid Nodule Cytology Samples Using Combined Mutational Detection and microRNA Classifier Test

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Outcomes of patients with thyroid nodules clinically tested using a combination of mutation and microRNA classification: Interim results of a clinical experience study

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Additional Studies

Utility of microdissected cytology smears for molecular analysis of thyroid malignancy. Diagn Cytopathol. Kumar G, 2018

This study was designed to determine if routinely prepared thyroid FNA cytology smears can be used for molecular profiling by NGS for oncogene mutations and oncogenic fusion transcripts, and by …

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Molecular classification of thyroid lesions by combined testing for miRNA gene expression and somatic gene alterations. Wylie D, 2016

This study examined a comprehensive evaluation of miRNA gene expression in diverse thyroid lesions (n=534) and developed predictive models for the classification of thyroid nodules. miRNA-based classifiers complemented and significantly …

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Presented Posters

Molecular Diagnosis of Medullary Thyroid Carcinoma

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Diagnostic Molecular Profiling Differentiating Noninvasive Follicular Thyroid Neoplasm with Papillary-like Nuclear Features (NIFTP) from Closely Related Entities

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Combined mutation detection ThyGenX® and miRNA classifier ThyraMIR® can be effectively performed on fixative-treated thyroid nodule clinical specimens

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Performance Attributes of Microdissected Slide-Format and Dedicated Needle Aspiration Biopsy Analysis of Indeterminate Thyroid Nodules

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Estimation of Malignancy Association For Mutations and Fusions, Detected by NGS, by Incorporating the Results of microRNA Expression Profiling Assay for a Large Set of Clinical Specimens

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The Majority of Non-­Diagnostic (Insufficient) Thyroid Nodule Cytology Samples Can Effectively Undergo Molecular (Combined Mutational and microRNA Classifier) Analysis Using a Needle Aspiration Approach

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MicroRNA Expression Profiling Differentiated Parathyroid Lesions

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Molecular Diagnosis of Medullary Thyroid Carcinoma by NGS Mutation Detection and microRNA Expression Profiling

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The addition of microRNA expression testing increases the sensitivity and specificity to detect thyroid cancer in pediatric patients

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Overcoming challenges in expanding NGS-based mutation panels to analyze indeterminate thyroid nodule aspirates

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MicroRNA Profiling Discriminates Nodular Hyperplasia Versus Follicular Adenoma

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microRNA Profiling Addresses Mutational Heterogeneity in Individual Thyroid Nodules

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microRNA (miRNA) Profiling Differentiates Noninvasive Follicular Thyroid Neoplasm with Papillary-like Nuclear Features (NIFTP) from Invasive Encapsulated Follicular Variant of PTC (iEFVPTC)

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MicroRNA Profiling Complements Microscopic/Mutational Analysis by Defining Alternative Pathways of Carcinogenesis

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Clinical and Biological Significance of Common Mutational Genotypes of Thyroid Follicular Neoplasia

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Video Presentations

Informed Risk Stratification and Patient Management with ThyGeNEXT and ThyraMIR

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Indeterminate Thyroid Nodules - Overcoming Diagnostic Uncertainty Using the Markers that Matter

Patient management decisions are based on the independent medical judgment of the physician and molecular test results should be taken into consideration in conjunction with all relevant imaging, clinical findings, patient and family history, as well as patient preference.

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