SOUTH SAN FRANCISCO, July 8, 2013 /PRNewswire/ -- Veracyte, Inc., a molecular diagnostics company pioneering the field of molecular cytology, today announced that Aetna, the third largest health plan in the United States, has issued a positive coverage policy for the company's Afirma Gene Expression Classifier. The policy now makes Veracyte's genomic test available to the insurer's estimated 22 million medical members, effective June 2013, for use in assessing thyroid nodule fine needle aspiration (FNA) biopsies that are indeterminate – not clearly benign or malignant following traditional cytopathology review. Veracyte's genomic test is now covered for approximately 110 million patients nationwide, including through Medicare, UnitedHealthcare and other, smaller private plans.
"We see this policy as a further confirmation of the utility of Afirma and are pleased that Aetna's members will be able to benefit from the new coverage," said Bonnie Anderson, cofounder and chief executive officer of Veracyte. "This should help to further reduce unnecessary thyroid surgeries and healthcare costs as part of thyroid cancer diagnosis."
Veracyte offers the Afirma Gene Expression Classifier as part of its Afirma Thyroid FNA Analysis. The solution combines specialist cytopathology assessment of thyroid nodule FNA samples with the Afirma Gene Expression Classifier, a genomic test used to clarify inconclusive results as benign or suspicious for cancer. 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 invasive diagnostic surgery.
According to the American Cancer Society, thyroid cancer is the fastest-increasing cancer in the U.S., with over 60,000 new cases expected in 2013. Among the approximately 525,000 FNAs performed on patients with thyroid nodules each year in the U.S., 15-30% 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% of these patients' nodules are diagnosed as benign.
Veracyte, Inc., based in South San Francisco, Calif., is a privately held molecular diagnostics company pioneering the field of molecular cytology. The company is focused on discovering, developing and commercializing molecular cytology solutions that enable physicians to make more informed treatment decisions at an early stage in patient treatment, thus helping patients avoid unnecessary invasive procedures while reducing healthcare costs. Veracyte's first product – the Afirma Thyroid FNA Analysis – was launched in 2011 and 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 a global co-promotion agreement with Genzyme, a Sanofi company, to make the Afirma Thyroid FNA Analysis more broadly available. Veracyte is privately held and funded by Domain Associates, Kleiner Perkins Caufield & Byers, TPG Biotech and Versant Ventures. Veracyte and Afirma are registered trademarks of Veracyte, Inc. All rights reserved.
SOURCE Veracyte, Inc.