About the Afirma Thyroid FNA Analysis
Veracyte's Afirma Thyroid FNA Analysis is designed to improve thyroid nodule diagnosis. This novel solution combines expert cytopathology assessment of thyroid nodule fine needle aspiration (FNA) samples with the company's Afirma Gene Expression Classifier, a genomic test used to clarify inconclusive results as benign or suspicious for cancer, and thus help patients avoid unnecessary surgery if their nodules are actually benign. The Afirma test is the only molecular test clinically validated in prospective, multicenter, double-blinded trials to meet the criteria of National Comprehensive Cancer Network (NCCN) guidelines for safely monitoring thyroid nodules in lieu of diagnostic surgery. The test is covered for Medicare and other insured patients and is available throughout the U.S. through a global co-promotion partnership with Genzyme, a Sanofi company.
Thyroid cancer is the fastest-increasing cancer in the U.S., with over 60,000 new cases expected in 2013, according to the American Cancer Society. Among the approximately 450,000 thyroid nodule FNAs performed each year in the U.S. to rule out cancer, 15-30% of the results are inconclusive, and most physicians recommend thyroid surgery for final diagnosis. Following surgery, however, 70-80% of patients' nodules are diagnosed as benign. These surgeries are invasive, expensive, and typically result in lifelong thyroid hormone replacement therapy for the patient.
About VeracyteVeracyte, Inc., based in South San Francisco, Calif., is a privately held molecular diagnostics company pioneering the emerging field of molecular cytology. The company discovers, develops and commercializes molecular diagnostic solutions that enable physicians to make more informed treatment decisions early, thus helping patients avoid unnecessary invasive procedures while reducing healthcare costs. Veracyte's first product – the Afirma® Thyroid FNA Analysis – combines specialized cytopathology assessment with the Afirma Gene Expression Classifier, a genomic test that clarifies inconclusive thyroid nodule results as benign or suspicious for cancer. The company has formed a global co-promotion partnership with Genzyme, a Sanofi company, to make the Afirma Thyroid FNA Analysis available throughout the U.S. and, subsequently, globally. Veracyte is currently in the early biomarker discovery phase for lung cancer and interstitial lung diseases. Veracyte is funded by Domain Associates, Kleiner Perkins Caufield & Byers, TPG Biotech and Versant Ventures. For more information, visit www.veracyte.com. Veracyte and Afirma are registered trademarks of Veracyte, Inc. All rights reserved.