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Endocr Pract. 2018 Nov 1. doi: 10.4158/EP-2018-0395. [Epub ahead of print]

STATISTICAL COMPARISON OF AFIRMA GSC AND AFIRMA GEC OUTCOMES IN A COMMUNITY ENDOCRINE SURGICAL PRACTICE: EARLY FINDINGS.

Abstract

OBJECTIVE:

The Veracyte Afirma Gene Expression Classifier (GEC) has been the most widely used negative predictive value molecular classifier for indeterminate cytology thyroid nodule aspirates (FNA's) since 1/2011. To improve specificity and further reduce unnecessary thyroid surgeries, a second generation assay (Afirma GSC) was released for clinical use in 8/2017. We report 11 months of clinical outcomes experience with the GSC and compare them to our 6.5 year experience with the GEC.

METHODS:

We searched our practice registry for FNA's with Afirma results from 1/2011-6/2018. GEC vs GSC results were compared overall, in oncocytic and non-oncocytic aspirates and by pathologic outcomes.

RESULTS:

GSC identified less indeterminate cytology nodules as suspicious (38.8%-54/139) when compared to GEC (58.4%-281/481). There was a decrease of in the percentage of oncocytic FNA subjects classified as suspicious in the GSC group, with 86 out of 104 oncocytic indeterminates (82.7%) classified as suspicious by GEC and 12 of 34 (35.3%) classified as suspicious by GSC. The surgery rate in patients with oncocytic aspirates fell from 56% in the GEC group to 31% in the GSC evaluated group (45%). Pathology analysis demonstrated a false negative percentage for an incomplete surgical group (FNP-ISG) of 9.5% for GEC and 1.2% for GSC.

CONCLUSIONS:

Our GSC data suggest that the GSC further reduces surgery in indeterminate thyroid nodules by improving the specificity of Afirma technology without compromising sensitivity. A primary determinant for this change is a significant improvement in the specificity of the Afirma GSC test in oncocytic FNA's.

KEYWORDS:

Afirma GEC®; Afirma GSC®; False Negative Percentage for an Incomplete Surgical Group- (FNP-ISG); non-invasive follicular tumor with papillary nuclear features (NIFTP); thyroid cancer

PMID:
30383497
DOI:
10.4158/EP-2018-0395

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