New Study Suggests That Use of Veracyte's Afirma® Gene Expression Classifier Helps to Significantly Reduce Surgeries in Patients with Ambiguous Thyroid Nodule Cytology Results

Veracyte, Inc., a molecular diagnostics company pioneering the emerging field of molecular cytology, and Genzyme, a Sanofi company

, today announced the publication of new data suggesting that routine clinical use of Veracyte's Afirma® Gene Expression Classifier helps to significantly reduce the number of surgeries performed on patients whose thyroid nodule cytology results are not clearly benign or malignant following traditional evaluation. The study found that when the genomic test reclassified "indeterminate" thyroid nodule fine needle aspiration (FNA) samples as "benign" – which data show it did approximately half the time – surgery rates for those patients decreased by 90%, compared to traditional surgery rates for patients with indeterminate cytology without molecular testing. The findings were published online in the journal Thyroid and underscore the clinical utility of the Afirma Gene Expression Classifier in helping to reduce thyroid surgeries and related costs as part of thyroid cancer diagnosis. Thyroid cancer is the fastest-increasing cancer in the United States, with an estimated 56,460 new cases expected in 2012, according to the American Cancer Society. Approximately 450,000 thyroid nodule FNAs – a minimally invasive procedure to extract cells for examination under a microscope – are performed each year in the U.S. to rule out cancer. In up to 30% of cases, the results are ambiguous, with current guidelines recommending surgery for most of these patients to remove all or part of their thyroid for final diagnosis. This approach is invasive, costly and can result in lifelong thyroid hormone therapy for the patients. Most of these patients (70-80%), however, turn out to have benign conditions.