Two New Studies Demonstrate the Long-Term Clinical Utility of Veracyte's Afirma Gene Expression Classifier in Safely Reducing Unnecessary Thyroid Surgeries

Veracyte, Inc. VCYT, a molecular diagnostics company pioneering the field of molecular cytology, announced findings from two new studies demonstrating the long-term clinical utility of the Afirma® Gene Expression Classifier (GEC). The genomic test is used to help avoid unnecessary surgeries among patients whose thyroid nodule fine needle aspiration (FNA) biopsy results are indeterminate (not clearly benign or cancerous). The new findings were presented today at the 15th International Thyroid Congress (ITC) and 85th Annual Meeting of the American Thyroid Association (ATA), being held October 18-23, 2015 in Lake Buena Vista, Fla. In the first study, researchers used the HealthCore Integrated Research Database (HIRD®) to compare outcomes during follow-up of 201 patients with benign Afirma GEC results to a matched control group of 603 patients with benign cytopathology results. They found that, over an average follow-up period of 20 months, Afirma GEC-benign patients were no more likely to undergo thyroid surgery than the control group (11 percent vs. 10 percent). The rate of ultrasound follow-up examinations was also similar among the Afirma GEC-benign patients (60 percent), compared to the cytopathology-benign group (62 percent). "Traditionally, many patients with indeterminate thyroid nodules could be directed to unnecessary thyroid surgery, only for many of them to learn afterwards that their nodules were benign," said Joseph Singer, M.D., chief medical officer of HealthCore, a wholly-owned subsidiary of Anthem, Inc., and lead author of the Veracyte-sponsored study. "Our findings suggest that use of the Afirma GEC could change the trajectory of care for many of these patients, enabling them to stay out of the operating room." Dr. Singer presented the data today in a poster titled, "Surgery Rates and Ultrasound Follow-Up for Afirma GEC Benign Patients are Equivalent to Matched Cytopathology Benign Patients in a National Managed Health Plan Database" (poster #30). The second clinical utility study assessed surgery rates for Afirma GEC-benign patients who were tested at 16 community-based practices and followed for three years. The researchers found that 81 out of 98 patients (82.7 percent) with a benign Afirma GEC result avoided surgery during 36 months of follow up, with the majority (88 percent) of any surgeries occurring within the first two years. In comparison, the historical rate of surgery avoidance is just 26 percent for patients with cytopathology-indeterminate nodules. "Our study showed that a 'benign' Afirma GEC result in a community setting is associated with a significantly lower rate of surgery compared to historical practice, over an extended period of time," said lead author Jennifer A. Sipos, M.D., associate professor of medicine at The Ohio State University. "Our findings suggest that a benign Afirma GEC result is durable and that physicians have high levels of confidence in the genomic test's ability to identify patients whose nodules are benign and may be observed in lieu of going to surgery." Dr. Sipos presented the study results in a poster titled, "Long-Term Non-Operative Rate of Thyroid Nodules with Benign Results on the Afirma Gene Expression Classifier" (poster #838). "The new data presented today highlight the profound, real-world impact that the Afirma GEC is having on clinical decision-making in thyroid cancer diagnosis," said Bonnie Anderson, president and chief executive officer of Veracyte. "We believe these findings further add to the growing library of clinical evidence supporting the continued adoption and reimbursement of the Afirma GEC." To date, the Afirma GEC is covered for approximately 150,000 Americans through their insurers. Veracyte also presented a poster today titled, "Afirma BRAF Testing Across Cytology Subtypes Among 9,188 Thyroid FNA Biopsies Demonstrates High Prevalence of BRAF V600E Mutations in Bethesda V and VI Nodules" (poster #301). The results show a doubling of the identification of BRAF-positive nodules in patients with a "suspicious" Afirma GEC result, compared to the general indeterminate group. The findings suggest the potential utility of such mutation testing in patients with a Afirma GEC-suspicious result, which may help physicians determine the extent of thyroid surgery needed.