PDI, Inc. (NASDAQ: PDII) subsidiary Interpace Diagnostics announced that effective June 2015, ThyGenX™,i the company’s genetic mutation panel, has been approved by Aetna for assessing fine needle aspiration (FNA) samples from indeterminate thyroid nodules. Aetna’s coverage decision now means that ThyGenX is considered medically necessary. Aetna covers 46 million lives and its positive coverage decision brings the total number of lives covered for ThyGenX to more than 100 million.
Approximately 15-30% of the 525,000 thyroid FNA’s performed on an annual basis are indeterminate based on standard cytological evaluation, and thus are candidates for ThyGenX. ThyGenX has been validated in a prospective, clinical study involving over 600 patients and has a specificity rate of 89%.ii
Guidelines from the National Comprehensive Cancer Network (NCCN) indicate that molecular diagnostic approaches may be useful in the evaluation of thyroid FNA samples that are indeterminate to assist in patient management, including identifying patients who are appropriate candidates for surgery and those for whom surveillance is appropriate.