ARTICLE | Clinical News

Afirma: Pivotal trial data

September 20, 2010 7:00 AM UTC

An ongoing U.S. pivotal trial evaluating 66 thyroid nodule FNA samples for which surgical pathology results were known showed that Veracyte's Afirma molecular classifier had 97% sensitivity, 64% specificity and a NPV of 98% for identifying benign tumors when compared to the current standard of 2 blinded expert histopathology reviews. In the 43 samples with indeterminate FNA cytology, the test had 95% sensitivity, 63% specificity and a NPV of 96% compared to the expert histopathology reads. The study collected 2,646 FNA samples from 2,077 patients with thyroid nodules >1 cm, of whom 210 underwent surgical thyroid resection and 85 had undergone expert histopathology review. Data were presented at the International Thyroid meeting in Paris. ...