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Multicenter Study
. 2023 Sep;45(9):2227-2236.
doi: 10.1002/hed.27472. Epub 2023 Jul 25.

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

Ivona Lončar  1 , Evert F S van Velsen  2 , Elske T Massolt  3 , Folkert J van Kemenade  4 , Adriana C H van Engen-van Grunsven  5 , Bettien M van Hemel  6 , Francien H van Nederveen  7 , Romana Netea-Maier  8 , Thera P Links  9 , Robin P Peeters  2 , Tessa M van Ginhoven  1
Affiliations
Multicenter Study

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

Ivona Lončar et al. Head Neck. 2023 Sep.

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.

Keywords: fine-needle aspiration; gene expression classifier; genomic sequencing classifier; indeterminate thyroid nodule.

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References

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