Afirma Thyroid FNA Analysis

The Evolved Solution for Improved Thyroid Nodule Assessment

Indeterminate* results on thyroid FNA samples are a common and significant problem for physicians and their patients. FNA samples can be challenging to interpret and produce inconclusive results in up to 30 percent of cases.1 Current guidelines recommend that most of these patients go to surgery.2-3 However, the majority of these cases end up being benign.1 Now, the Afirma Thyroid FNA Analysis delivers physicians an improved solution to better assess thyroid nodules.4-6  The Afirma Thyroid FNA Analysis combines expert cytopathology and the novel Afirma Gene Expression Classifier.

The Afirma Thyroid FNA Analysis begins with a thorough cytopathological evaluation by an expert at Thyroid Cytopathology Partners (TCP), an independent laboratory partner of Veracyte. Typically, a Patient Report can be issued based on cytopathology assessment alone with a final benign or malignant diagnosis. When TCP's cytopathology assessment yields an indeterminate* diagnosis, Veracyte's proprietary Gene Expression Classifier is performed and classifies the nodule as benign (>95% NPV) or suspicious.4-6  Regardless of path, the Afirma Thyroid FNA Analysis delivers to physicians clearer Patient Reports to help actionable treatment decisions.

The Gene Expression Classifier was developed  through a rigorous scientific program to identify benign nodules, which were initially diagnosed by cytopathology as indeterminate. Two prospective, independent, multi-center validation studies have shown the Afirma Gene Expression Classifier to have a negative predictive value (NPV) of greater than 95% (less than 5% risk of malignancy) on samples identified as benign by the Gene Expression Classifier.5-6 This level of accuracy may allow treating physicians to recommend routine follow-up for their patients with thyroid nodules rather than surgery.

* Indeterminate includes Follicular Lesion of Undetermined Significance (FLUS)/Atypia of Undetermined Significance (AUS) and (suspicious for) Hürthle/Follicular Neoplasm.
1. Lewis CM et al. 2009 Thyroid 19(7) 717-722.
2. Cooper DS et al. 2009 Thyroid 19(11) 1167-214.
3. Gharib H, AACE/AME/ETA Thyroid Nodule Guidelines, Endoc Pract. 2010:16(Suppl 1).
4. Data on File
5. Haugen BR et al. abstract #LB137, ITC, Paris, FR 2010 [oral abstract].
6. Chudova et al. 2010 JCEM 95(12) 5301-5309.