NEW YORK (GenomeWeb News) – Veracyte today announced that private payor UnitedHealthcare has issued a positive medical coverage policy for the firm's molecular diagnostic test for thyroid cancer.
The decision by UHC, which covers about 27 million commercial members, pertains to Veracyte's Afirma Gene Expression Classifier for assessing thyroid nodule fine needle aspirate biopsies that are neither clearly benign nor malignant based on cytology review. The policy takes effect April 1.
The Afirma test is also covered for about 40 million patients by Medicare and is available in the US through a co-promotion partnership with Genzyme.
The test measures the expression of 142 genes and helps identify patients with benign nodules, who could then bypass unnecessary diagnostic surgery. Another 25 supplemental genes are used to improve classification of rare cancer subtypes. Veracyte offers Afirma as part of its comprehensive Afirma Thyroid FNA Analysis combining specialized cytopathology with the gene expression test to clarify inconclusive results.
According to the South San Francisco, Calif.-based company, UHC's decision is consistent with the National Comprehensive Cancer Network Thyroid Carcinoma Guidelines recommending the use of molecular diagnostics to identify patients with indeterminate cytopathology results. The test, Veracyte said, is the only molecular test that has been clinically validated in prospective, multicenter, double-blinded trials to meet NCCN's validation benchmark to "safely monitor nodules in lieu of diagnostic surgery."
Because of UnitedHealthcare's decision to cover the test, "more patients will be able to avoid unnecessary thyroid surgeries, and healthcare costs for the management of indeterminate thyroid nodules will be reduced," Veractye Co-founder and CEO Bonnie Anderson said in a statement.
Citing statistics from the American Cancer Society, Veracyte said that thyroid cancer is the fastest-increasing cancer in the US with an anticipated 60,220 new cases in 2013.