Veracyte presents data on clinical utility of Afirma® Gene Expression Classifier
April 2, 2016 – SOUTH SAN FRANCISCO. Veracyte, Inc., a molecular diagnostics company pioneering the field of molecular cytology, announced findings from two new studies demonstrating the clinical utility of the Afirma Gene Expression Classifier (GEC). The genomic test is used to rule out cancer in thyroid nodules deemed indeterminate (not clearly benign or malignant) following traditional cytopathology evaluation so that these patients can potentially avoid an unnecessary surgery. The findings were presented at ENDO 2016, the annual meeting of the Endocrine Society, being held April 1-4 in Boston.
In the first study, Veracyte researchers conducted a systematic review of published data through March 2016 to determine the impact of the Afirma GEC on patient care. Among the 13 studies evaluated, which involved 1,842 patients with Afirma GEC results, the researchers found that 833 patients (45 percent) had “benign” Afirma GEC results, of which 87 (10 percent) went to surgery. Using historical, control-group surgery rates for indeterminate thyroid nodules – recorded in three of the studies – the researchers concluded that use of the Afirma GEC resulted in a 25 percent lower overall surgery rate among all patients with benign or suspicious Afirma GEC results in the 13 studies. Follow-up of Afirma GEC benign nodules was reported in six studies for 457 patients. The median follow-up ranged from 7 to 26 months, during which 393 patients (86 percent) with Afirma GEC benign results had avoided surgery.
“Our findings demonstrate the significant positive, real-world impact that the Afirma GEC is having on patient care,” said Richard T. Kloos, M.D., senior director of endocrinology at Veracyte and lead author of the study. “Specifically, these data show that, across a range of clinical settings, the test is helping physicians improve care by avoiding unnecessary diagnostic surgery for their patients. This is important because these surgeries are invasive, costly and often subject patients to lifelong daily thyroid hormone medication.”
In the second study, researchers at the University of North Dakota School of Medicine and Health Sciences evaluated the impact of the Afirma GEC on patient care at a local community hospital and found that one patient avoided surgery for every two genomic tests performed. The findings were based on a retrospective review of medical records for 66 patients with Afirma GEC testing results for thyroid nodules that were deemed indeterminate by cytopathology, between April 1, 2012 and October 31, 2014.
“The studies presented today further establish the Afirma GEC as a new standard of care in thyroid cancer diagnosis,” said Bonnie Anderson, Veracyte’s president and chief executive officer. “Since the test’s launch in 2011, we estimate that it has helped more than 20,000 patients avoid an unnecessary thyroid surgery and has provided hundreds of millions of dollars in savings to the healthcare system.”
In a separate study presented at ENDO 2016, Veracyte scientists used deep RNA sequencing and other approaches to identify evidence of genomic instability on a subset of Hürthle cell tumors, which may not be observable through histopathological review. The researchers concluded that the findings suggest the potential utility of deep RNA sequencing to help to diagnose this often difficult to detect type of thyroid neoplasm.
Veracyte’s Afirma Thyroid FNA Analysis is a comprehensive solution for improved thyroid nodule assessment. It centers on the Afirma Gene Expression Classifier, a 142-gene molecular test that identifies benign thyroid nodules among those deemed indeterminate by cytopathology, enabling these patients to potentially avoid an unnecessary surgery. An additional 25 genes are used to differentiate uncommon neoplasm subtypes. The company’s Afirma Malignancy Classifiers - comprising tests for medullary thyroid cancer and BRAF gene mutation status - are designed to inform surgical strategy for those patients headed to surgery based on their cytopathology or Afirma GEC results.