NEW YORK (GenomeWeb) – Interpace Diagnostics said on Monday that Aetna has published a favorable coverage policy for the firm's ThyGenX genetic mutation panel for assessing fine needle aspiration samples from indeterminate thyroid nodules.
Interpace, a subsidiary of PDI, said that Aetna considers the test medically necessary and started covering the test last month. PDI CEO Nancy Lurker added in a statement that Aetna is the first major commercial insurer to cover ThyGenX. The insurer covers 46 million lives and with the positive coverage decision, the number of covered lives for ThyGenX totals more than 100 million.
ThyGenX is a next-generation sequencing-based panel for making surgical decisions about patients with thyroid nodules when standard cytopathology does not provide a clear diagnosis for thyroid cancer. It assists clinicians differentiate between benign and malignant indeterminate thyroid nodules by identifying more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas.
Interpace said that the 15 to 30 percent of the 525,000 thyroid fine needle aspiration samples performed each year that are indeterminate based on standard cytology are candidates for the test. ThyGenX was validated in a prospective, clinical study with more than 600 patients and has a specificity of 89 percent.