Gene Expression Classifier versus Targeted Next-Generation Sequencing in the Management of Indeterminate Thyroid Nodules.

Gene Expression Classifier versus Targeted Next-Generation Sequencing in the Management of Indeterminate Thyroid Nodules.

J Clin Endocrinol Metab. 2018 Mar 23;:

Authors: Livhits MJ, Kuo EJ, Leung AM, Rao J, Levin M, Douek ML, Beckett KR, Zanocco KA, Cheung DS, Gofnung YA, Smooke Praw S, Yeh MW

Abstract
Context: Molecular testing has reduced the need for diagnostic hemithyroidectomy for indeterminate thyroid nodules. No studies have directly compared molecular testing techniques.
Objective: Compare diagnostic performance of Afirma Gene Expression Classifier (GEC) and ThyroSeq v2 next-generation sequencing assay.
Design: Parallel randomized trial, monthly block randomization of patients with Bethesda III / IV cytology to GEC or ThyroSeq v2.
Setting: University of California, Los Angeles.
Participants: Patients who underwent thyroid biopsy (April 2016 - June 2017).
Interventions: Testing with GEC or ThyroSeq v2.
Main Outcome Measures: Molecular test performance.
Results: Of 1,372 thyroid nodules, 176 (13%) had indeterminate cytology and 149 of 157 eligible indeterminate nodules (95%) were included in the study. Of nodules tested with GEC, 49% were suspicious, 43% were benign, and 9% were insufficient. Of nodules tested with ThyroSeq v2, 19% were mutation positive, 77% were mutation negative, and 4% were insufficient. The specificities of GEC and ThyroSeq v2 were 66% and 91%, respectively (P=0.002); the positive predictive value of GEC and ThyroSeq v2 were 39% and 57%, respectively. Diagnostic hemithyroidectomy was avoided in 28 patients tested with GEC (39%) and 49 patients tested with ThyroSeq v2 (62%). Surveillance ultrasounds were available for 46 nodules (45 remained stable).
Conclusions: ThyroSeq v2 had higher specificity compared to Afirma GEC and allowed more patients to avoid surgery. Long-term surveillance is necessary to assess the false-negative rate of these particular molecular tests. Further studies are required for comparison with other available molecular diagnostics and for newer tests as they are developed.

PMID: 29590358 [PubMed - as supplied by publisher]

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