Performance characteristics of ThyroSeq, ThyGeNEXT/ThyraMIR, and Afirma molecular platforms in evaluation of 1252 cytologically-indeterminate thyroid nodules.

Introduction: The preoperative risk stratification of thyroid nodules with indeterminate cytology on fine needle aspiration has been streamlined with the application of molecular diagnostics. Most molecular platforms use genotyping and mRNA or microRNA expression profiling to assign a preoperative cancer risk to thyroid nodules.

Materials and methods: In this study, we discuss the general methodology and compare the diagnostic accuracy of 3 commercially available molecular platforms, ThyroSeq, ThyGeNEXT/ThyraMIR, and Afirma, in the evaluation of 1252 cytologically indeterminate thyroid nodules.

Results: Molecular evaluation showed an increased malignancy risk in 28.7% of cases. Of all cases, 209 underwent partial or complete thyroid resection. 34.9% of these resected thyroid nodules were benign and non-neoplastic, 16.3% were benign neoplasms and 48.8% were malignant neoplasms. 5.5% (n = 49) of cases with negative molecular testing were found to have a neoplasm on subsequent thyroid resection. 40.8% of these cases showed benign neoplasms and 59.2% showed a malignant neoplasm.

Conclusions: The ThyroSeq, ThyGeNEXT/ThyraMIR, and Afirma molecular platforms demonstrate similar efficacy in ruling out malignancy in our cohort's cytologically indeterminate thyroid nodules, with sensitivities of 87.5%, 66.7%, and 73.1%, respectively, and negative predictive values of 80.0%, 70.0%, and 66.0%, respectively. Overall performance characteristics of these molecular platforms in our study are inferior to some previously published studies.