NEW YORK (GenomeWeb News) — Veracyte said today that Medicare contractor Palmetto GBA has agreed to cover its Afirma Gene Expression Classifier for use in thyroid nodule diagnosis.
The coverage decision means that Veracyte's genomic test "is now accessible to 40 million Medicare patients nationwide," the company said.
The Afirma test is intended to determine whether inconclusive thyroid nodule results are benign or suspicious for cancer.
The company said that around 450,000 thyroid nodule fine-needle aspiration tests are performed each year in the US, but the results are ambiguous in up to 30 percent of cases. Current guidelines recommend surgery for most of these ambiguous cases, even though inconclusive FNA results carry only a 20 percent to 30 percent chance of malignancy.
Bonnie Anderson, co-founder and CEO of Veracyte, said in a statement that Palmetto's decision "will help Medicare patients with inconclusive results access our Afirma Gene Expression Classifier, enabling them to potentially avoid surgery, while also saving money for the Medicare program."