Clinical Performance and Utility of Afirma GEC in a Community Hospital Practice

Program: Abstracts - Orals, Poster Previews, and Posters
Session: SAT 270-310-Thyroid Neoplasia (posters)
Saturday, April 2, 2016: 1:15 PM-3:15 PM
Exhibit/Poster Hall (BCEC)

Poster Board SAT 282
Michael Donovan Traynor Jr.*1, Jacob Torrison2, Julie E Hallanger-Johnson3, David William Newman3 and James R Beal1
1University of North Dakota School of Medicine and Health Sciences, 2University of North Dakota School of Medicine and Health Sciences, Fargo, ND, 3Sanford Health, Fargo, ND
PURPOSE: To assess the performance of the Veracyte’s Afirma Gene Expression Classifier (GEC) in a large community hospital setting.


BACKGROUND: Molecular markers are increasingly employed as an adjunct to fine needle aspiration (FNA) cytology in nodules with indeterminate classification. It is has been recommended that nodules read as Atypia of Undetermined Significance or Follicular Lesion of Undetermined Significance (AUS/FLUS), Follicular or Hürthle Cell Neoplasm (FN/HCN) have such testing.


METHOD: Retrospective review of medical records of patients who underwent FNA of thyroid nodules from April 1, 2012 to October 31, 2014 at Sanford Health, Fargo, North Dakota. Analyzed patients who underwent Afirma GEC testing. Nodule and patient characteristics, FNA cytology, Afirma GEC results, and subsequent clinical or surgical follow-up were obtained for 70 patients of 831 patients.  

RESULTS: Sixty-six patients had Afirma GEC clinically actionable results available for analysis (48 AUS/FLUS; 13 SFN; and 5 HCN). Thirty-seven of 66 patients had benign GEC results (56.1%), whereas 29 patients (43.9%) had suspicious results. One patient avoided surgery for every two GEC tests run as 35 of 37 patients with benign GEC profile elected conservative follow-up. Twenty-six of 29 patients with Afirma suspicious results underwent surgery with final pathologic diagnosis (rate of malignancy in GEC-suspicious nodules was 42.3%).


CONCLUSION: Though FNA classification is variable across institutions, the implementation of the Afirma GEC leads to a significant reduction in unnecessary thyroid surgery when applied to a population at a large community medical center. The results of benign calls by the Afirma GEC and malignancy rate within GEC-suspicious nodules is in line with previous results published and purported Veracyte.

Nothing to Disclose: MDT Jr., JT, JEH, DWN, JRB

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