Labourier E, Shifrin A, Busseniers AE, et al. Molecular Testing for miRNA, mRNA, and DNA on Fine-Needle Aspiration Improves the Preoperative Diagnosis of Thyroid Nodules With Indeterminate Cytology. J Clin Endocrinol Metab. 2015;100(7):2743-2750.

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 with AUS/FLUS or FN/SFN cytology collected from 16 physicians at 12 centers across the United States were tested using a panel of 17 validated gene alterations. Nodules negative for gene mutations were then tested with a 10-miRNA gene expression classifier. Mutations were detected in 69% of nodules with malignant outcomes. Among mutation-negative specimens, miRNA testing correctly identified 64% of malignant cases and 98% of benign cases. The diagnostic sensitivity and specificity of the combined algorithm was 89% (95% confidence intervals (CI): 73%-97%) and 85% (95% CI: 75%-92%), respectively. Independently of variations in cancer prevalence, the test increased the yield of true benign results by 65% relative to mRNA-based gene expression classification, and decreased the rate of avoidable diagnostic surgeries by 69%. It was therefore concluded that this unique combined testing approach can accurately classify benign and malignant thyroid nodules, increase the diagnostic yield of molecular cytology, and further improve the preoperative risk-based management of benign nodules with AUS/FLUS or FN/SFN cytology.

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.

Labourier E, Shifrin A, Busseniers AE, et al. Molecular Testing for miRNA, mRNA, and DNA on Fine-Needle Aspiration Improves the Preoperative Diagnosis of Thyroid Nodules With Indeterminate Cytology. J Clin Endocrinol Metab. 2015;100(7):2743-2750.

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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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