Highmark, Horizon issued positive coverage policies for Afirma Gene Expression Classifier

VeracyteJul 3 2014

Veracyte, Inc., a molecular diagnostics company pioneering the field of molecular cytology, today announced that two Blue Cross Blue Shield (BCBS)–affiliated organizations, Highmark Inc. and Horizon Blue Cross Blue Shield of New Jersey, have issued positive coverage policies for the company's Afirma® Gene Expression Classifier (GEC). Both companies have classified the genomic test as medically necessary for use in assessing thyroid nodule fine needle aspiration (FNA) biopsies that are indeterminate following traditional cytopathology review.

Highmark and Horizon are among four BCBS-affiliated organizations – including Wellmark Blue Cross and Blue Shield and Premera Blue Cross – to recently issue positive coverage decisions for the Afirma GEC. Highmark represents 4 million lives and Horizon represents 3.6 million, bringing the total number of BCBS lives covered by the Veracyte genomic test to more than 10 million. The policies will be effective for these organizations as of September 1, 2014 and July 26, 2014, respectively. The Afirma GEC is now covered for more than 135 million lives nationwide.

"These positive coverage decisions by Highmark and Horizon further demonstrate the compelling value that the Afirma Gene Expression Classifier delivers to patients, medical professionals and insurers," said Bonnie H. Anderson, president and chief executive officer of Veracyte. "Our test helps patients avoid unnecessary surgeries, while lowering healthcare costs. We are extremely pleased that it will now be available to over 10 million Blue Cross and Blue Shield members."

The Afirma GEC is the only molecular test with peer-reviewed, published data showing that it meets the performance criteria for inclusion in the National Comprehensive Cancer Network (NCCN), UpToDate® and preliminary American Thyroid Association guidelines – to enable patients with indeterminate cytopathology and benign Afirma GEC results to opt for routine monitoring in lieu of diagnostic surgery.

Veracyte offers the Afirma Gene Expression Classifier (GEC) as part of its Afirma Thyroid FNA Analysis. This comprehensive solution combines specialist cytopathology assessment of thyroid nodule FNA samples with the Afirma Gene Expression Classifier, a genomic test used to identify benign thyroid nodules among those deemed inconclusive based on cytopathology. The company recently added its Afirma Malignancy Classifiers – genomic tests for medullary thyroid cancer and the BRAF gene mutation – to help guide surgical strategy for those patients who need surgery.