Veracyte Reports Publication of New Long-Term Outcome Study for Afirma

Veracyte, Inc.

, a molecular diagnostics company pioneering the field of molecular cytology, today announced the publication of new long-term outcome data supporting the use of the Afirma Gene Expression Classifier (GEC) to identify patients whose thyroid nodules are noncancerous – and can thus safely avoid unnecessary surgery – when their fine needle aspiration (FNA) biopsy results are inconclusive. The study, led by researchers at Brigham & Women's Hospital, appears online in The Journal of Clinical Endocrinology & Metabolism. "Our findings show that thyroid nodules classified as benign by the Afirma GEC have similar growth during follow-up as nodules that are benign by cytopathology, which suggests comparable clinical behavior," said Trevor E. Angell, M.D., endocrinologist at Brigham & Women's Hospital and lead author of the new study. "These data suggest that physicians can confidently monitor patients with benign GEC results, just as they would with patients whose cytopathology results are benign." The researchers evaluated 90 patients whose thyroid nodule FNAs were deemed benign by the Afirma GEC (following indeterminate cytopathology) between 2010 and 2014. Using ultrasound data available for 58 nodules in 56 of the patients, they compared rates of significant growth – an indicator of potential cancer – over a median of 13 months (range of 4-40 months) to those of 1224 thyroid nodules with benign cytopathology results. The latter were from 873 patients who underwent FNA procedures over a ten-year period prior to introduction of the Afirma GEC and who were followed with ultrasound for a similar period of time. They found that Afirma-benign nodules showed similar growth as the cytopathology-benign cases using either of two criteria: greater than or equal to 20 percent in two dimensions (8.6 percent vs. 8.3 percent) or greater than or equal to 50 percent in volume (17.2 percent vs. 13.8 percent). Patients in the Afirma-benign group were more likely to undergo surgery (13.8 percent vs. 0.9 percent), but cancer was only found in one patient. The authors note that they report on change in Afirma-benign nodules during a clinically relevant monitoring period, as cytologically benign thyroid nodules are typically followed with ultrasound at 6-18 months. Additionally, most of the patients studied remain in the care of Brigham & Women's Hospital, with up to four years of follow-up since their initial Afirma-benign result. "These findings add to the growing body of rigorous clinical evidence that underscores the clinical utility of the Afirma GEC in helping patients with thyroid nodules avoid unnecessary surgery, while reducing healthcare costs," said Bonnie H. Anderson, Veracyte's president and chief executive officer. "We believe that, with its demonstrated value to patients, physicians and payers, the Afirma GEC is becoming the new standard of care in thyroid cancer diagnosis." Since its introduction the Afirma GEC has been performed on nearly 40,000 patients. According to the American Cancer Society, thyroid cancer is the fastest-increasing cancer in the United States, with more than 62,000 new cases expected in 2015. Among the approximately 525,000 fine-needle aspirations performed on patients with thyroid nodules each year in the United States, 15-30 percent of the results are inconclusive in ruling out cancer, and most physicians have traditionally recommended thyroid surgery for final diagnosis. Following surgery, however, 70-80 percent of these patients' nodules are diagnosed as benign.