European experience with the Afirma Gene Expression Classifier for indeterminate thyroid nodules: A clinical utility study in the Netherlands

Ivona Lončar*, Evert F.S. van Velsen*, Elske T. Massolt, Folkert J. van Kemenade, Adriana C.H. van Engen-van Grunsven, Bettien M. van Hemel, Francien H. van Nederveen, Romana Netea-Maier, Thera P. Links, Robin P. Peeters, Tessa M. van Ginhoven

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

Background: The Gene Expression Classifier (GEC) and Genomic Sequencing Classifier (GSC) were developed to improve risk stratification of indeterminate nodules. Our aim was to assess the clinical utility in a European population with restrictive diagnostic workup. Methods: Clinical utility of the GEC was assessed in a prospective multicenter cohort of 68 indeterminate nodules. Diagnostic surgical rates for Bethesda III and IV nodules were compared to a historical cohort of 171 indeterminate nodules. Samples were post hoc tested with the GSC. Results: The GEC classified 26% as benign. Surgical rates between the prospective and historical cohort did not differ (72.1% vs. 76.6%). The GSC classified 59% as benign, but misclassified six malignant lesions as benign. Conclusion: Implementation of GEC in management of indeterminate nodules in a European country with restrictive diagnostic workup is currently not supported, especially in oncocytic nodules. Prospective studies with the GSC in European countries are needed to determine the clinical utility.

Original languageEnglish
Pages (from-to)2227-2236
Number of pages10
JournalHead and Neck
Volume45
Issue number9
Early online date25 Jul 2023
DOIs
Publication statusPublished - Sept 2023

Bibliographical note

ACKNOWLEDGMENT:
Logistics of this investigator initiated research project was supported by an unrestricted research grant from Veracyte.

Publisher Copyright:
© 2023 The Authors. Head & Neck published by Wiley Periodicals LLC.

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