NEW YORK (GenomeWeb) – Interpace Diagnostics announced today that it has received approval from the New York State Department of Health (NYSDOH) for its TERT test offering, which is designed to detect a molecular biomarker of thyroid cancer aggressiveness.
The approval allows Interpace to offer TERT testing alone or in conjunction with its NYSDOH-approved ThyGenX next-generation sequencing oncogene panel for classifying indeterminate thyroid nodules throughout New York.
According to Interpace, TERT — short for telomerase reverse transcriptase — encodes the reverse transcriptase component of telomerase, which adds telomere repeats to chromosome ends, thereby enabling cell replication. Coexisting mutations in TERT and the oncogene BRAF have been linked to a significant increase in the risk of thyroid cancer aggressiveness, tumor recurrence, and thyroid cancer-specific deaths, the company added.
Earlier this year, Interpace added TERT to the ThyGenX panel, which includes several biomarkers predictive of thyroid cancer including BRAF, HRAS, KRAS, NRAS, RET/PTC, PAX8/PPARy, and PIK3CA.
"No other diagnostics company has been able to successfully incorporate the TERT biomarker into a combination testing algorithm product offering," Interpace President and CEO Jack Stover said in a statement. "Further, TERT is well recognized as one of the most aggressive biomarkers for thyroid cancer."
Interpace reported this week that its third quarter revenues rose 27 percent amid increased demand and reimbursement for its thyroid assays.