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

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...

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Published in:Head & neck 2023-09, Vol.45 (9), p.2227-2236
Main Authors: Lončar, Ivona, Velsen, Evert F. S., Massolt, Elske T., Kemenade, Folkert J., Engen‐van Grunsven, Adriana C. H., Hemel, Bettien M., Nederveen, Francien H., Netea‐Maier, Romana, Links, Thera P., Peeters, Robin P., Ginhoven, Tessa M.
Format: Article
Language:English
Subjects:
fine‐needle aspiration
Gene expression
gene expression classifier
genomic sequencing classifier
indeterminate thyroid nodule
Nodules
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Summary: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.
ISSN:1043-3074
1097-0347
DOI:10.1002/hed.27472