afirma

Name	Afirma® Thyroid FNA Analysis
Description	The novel Afirma Gene Expression Classifier (GEC), the centerpiece of the Afirma Thyroid FNA Analysis, helps physicians reduce the number of avoidable surgeries by preoperatively identifying benign nodules among those that were originally classified by cytopathology as indeterminate. The GEC measures the expression of 142 genes to determine if the FNA sample is benign or suspicious for cancer — enabling patients with benign results to potentially avoid unnecessary surgery.
Performance	Veracyte introduced its Afirma Malignancy Classifiers to further establish the Afirma Thyroid FNA Analysis as a comprehensive tool for reducing unnecessary surgeries and healthcare costs. Medullary thyroid cancer (MTC) is an aggressive type of thyroid cancer that is not definitively identified by cytopathology alone about half of the time.20 About 40% of patients with MTC do not undergo a total thyroidectomy with central neck dissection – the recommended treatment in current guidelines.2,21,22 As a result, many patients with MTC may subsequently undergo a “follow-up” surgery, once the presence of MTC becomes known. The presence of the BRAF V600E gene mutation may also prompt surgeons to perform more extensive thyroid surgeries.
Intended to use	The Afirma Malignancy Classifiers comprise tests for MTC and to assess BRAF V600E gene mutation status, and are intended to provide physicians with preoperative information that can enable them to perform a more appropriate procedure the first time, potentially reducing the need for additional surgeries – and the risks and costs that accompany them.
Regulatory Status	CLIA cleared
Partner	Veracyte