NEW YORK (GenomeWeb) – Interpace Diagnostics announced today that it has received approval to launch its ThyGeNext assay in New York and Pennsylvania, allowing the firm to sell the thyroid cancer detection assay to physicians in the two states.
According to Interpace, the Pennsylvania approval is final, while the New York state approval is conditional — final approval in New York with depend on Interpace's submission of additional information to state regulators. Interpace said it will sell ThyGeNext in New York and Pennsylvania in combination with its ThyraMir microRNA gene expression classifier.
The ThyGeNext panel — which was launched in May to build on the company's ThyGenX panel — uses next-generation sequencing to identify more than 150 genomic alterations associated with papillary, medullary, and follicular thyroid carcinomas. The tool includes multiple additional molecular markers, gene mutations, and RNA fusions than Interpace's previous thyroid cancer diagnostic assays including PTEN, ALK, TERT, RET, and NTRK, among others, the firm said. The new assay also interrogates a more comprehensive set of indicators to identify malignant or benign nodules, as well as to confirm cancer aggressiveness and other characteristics.
In June, Interpace announced that Blue Cross Blue Shield began covering its ThyGenX and ThyraMir gene panels in Florida.
In addition to its thyroid cancer line, Interpace will transition its pancreatic cancer assays to an NGS platform for testing biliary strictures and solid pancreatic lesions.
"We are pleased that we are now able to sell our newest thyroid product in these key markets representing significant opportunity for us, but also for physicians and their patients in these states as well," Interpace President and CEO Jack Stover said in a statement.