Has Afirma gene expression classifier testing refined the indeterminate thyroid category in cytology?

Cancer Cytopathol. 2016 Feb;124(2):100-9. doi: 10.1002/cncy.21624. Epub 2015 Sep 30.

Abstract

Background: Thyroid fine-needle aspiration (FNA) plays a pivotal role in the evaluation of thyroid nodules. Up to 30% of cases are diagnosed as indeterminate by FNA, including atypia of undetermined significance, follicular lesion of undetermined significance, suspicious for a follicular neoplasm, and follicular neoplasm, with approximately two-thirds having a benign outcome. The gene expression classifier (GEC) test is a molecular test for cases with indeterminate cytology. The purpose of the current study was to examine the refining role of the GEC test within a single institution.

Methods: Retrospective analysis of all thyroid FNAs during a 20-month period after implementation of GEC was performed. Cases of indeterminate cytology with concomitant GEC testing were selected and divided further in 4 subgroups. Correlation with surgical follow-up, when available, was performed. The results were compared with previously published data from the study institution before the implementation of GEC testing.

Results: Among the 217 cases, there were 189 with indeterminate cytology, 42% of which were benign and 50% of which were suspicious by GEC. The excisional rate of atypia of undetermined significance-follicular lesion of undetermined significance in the pre-GEC category was 63%, which decreased to 35% in the post-GEC category, whereas the malignancy rate in the excised thyroids increased from 35% in the pre-GEC category to 47% in the post-GEC category. Similar findings also were obtained for suspicious for a follicular neoplasm-follicular neoplasm lesions.

Conclusions: The strength of the GEC test appears to lie in its ability to reclassify 42% of indeterminate cytology cases as benign, thereby decreasing the number of unnecessary surgical procedures.

Keywords: Afirma; atypia of undetermined significance; fine-needle aspiration; follicular lesion of undetermined significance; follicular neoplasia; gene expression classifier; indeterminate cytology; thyroid.

Publication types

  • Comparative Study

MeSH terms

  • Adult
  • Aged
  • Biopsy, Fine-Needle / methods
  • Cohort Studies
  • Cytodiagnosis / classification*
  • Cytodiagnosis / methods
  • Diagnosis, Differential
  • Female
  • Gene Expression Profiling / methods*
  • Gene Expression Regulation, Neoplastic
  • Humans
  • Immunohistochemistry
  • Male
  • Middle Aged
  • Retrospective Studies
  • Sensitivity and Specificity
  • Thyroid Neoplasms / classification
  • Thyroid Neoplasms / pathology*
  • Thyroid Neoplasms / surgery*
  • Thyroid Nodule / classification
  • Thyroid Nodule / pathology*
  • Thyroidectomy / methods
  • Young Adult