Veracyte, a genomic diagnostics company focused on reducing unnecessary surgeries and healthcare costs by resolving diagnostic uncertainty, has announced that Anthem, an independent Blues plan and one of the nation's largest health benefits companies, has issued a positive coverage policy for Veracyte's Afirma Gene Expression Classifier (GEC) for use in thyroid cancer diagnosis. The policy renders the genomic test a medically necessary benefit for Anthem's approximately 40 million members, effective immediately. The Afirma GEC is the only genomic test for use in thyroid cancer diagnosis to receive such a designation in the plan's new coverage policy.

The Afirma GEC is used to identify patients with benign thyroid nodules among those whose fine needle aspiration (FNA) biopsy results are indeterminate following traditional cytopathology review, so that they may avoid an unnecessary diagnostic surgery. The new policy brings the total number of covered lives for the genomic test to more than 260 million, including over 110 million Blues plan members. The Afirma GEC is now covered by Blues plans in 46 of the nation's 50 states.

"We are delighted that Anthem's members will now have access to the Afirma test as a covered benefit," said Bonnie Anderson, Veracyte's chief executive officer and chairman. "With this coverage decision, every major health plan in the United States now covers Afirma, which we estimate has helped save tens of thousands of patients from unnecessary surgery since its introduction in 2011. This is a significant corporate milestone for us, as Afirma is one of the only tests in the genomic diagnostics sector to achieve such broad coverage."

Each year in the United States, more than 525,000 fine needle aspiration biopsies are performed to assess patients with potentially cancerous thyroid nodules. Up to 30 percent of the results are indeterminate (not clearly benign or malignant) and physicians have traditionally recommended thyroid surgery for a more definitive diagnosis. Following surgery, however, 70 to 80 percent of patients' nodules are diagnosed as benign, meaning the surgery was unnecessary. Such surgery is invasive, costly and often leads to the need for lifelong daily thyroid hormone replacement drugs.

The Afirma Gene Expression Classifier has become a new standard of care in thyroid cancer diagnosis, where it is used to identify patients with benign thyroid nodules among those with indeterminate cytopathology results in order to preserve the thyroid. The Afirma Genomic Sequencing Classifier (GSC), introduced in May 2017, is the next-generation version of the Afirma GEC and combines RNA sequencing and machine learning for enhanced performance. Clinical data demonstrate that the enhanced test maintains the GEC's high sensitivity, while increasing its specificity, to enable significantly more patients to avoid unnecessary surgery as part of thyroid cancer diagnosis.