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Interpace Diagnostics Receives NYS DOH Approval for Thyroid Oncogene Panel

NEW YORK (GenomeWeb) – Interpace Diagnostics announced today that it has received approval from the New York State Department of Health to market its ThyGenX next-generation sequencing oncogene panel for indeterminate thyroid nodules.

In early August, the company said that its ThyraMir thyroid cancer classifier test had been approved by New York State, and that it planned to submit ThyGenX for approval as well.

ThyGenX uses NGS to identify more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas, the company said. ThyraMir analyzes the expression of 10 cancer-linked microRNAs to classify thyroid nodules as cancerous or benign following indeterminate results from fine-needle aspirate and biopsy samples.

The state's approval for both tests means they can be marketed and used together, as the use of ThyGenX typically precedes ThyraMir, the firm said, adding that 82 percent of ThyGenX cases warrant microRNA assessment with ThyraMir.

"We are pleased with the New York State acceptance of our data submission for ThyGenX and are prepared to leverage this opportunity right away," said Interpace President and CEO Jack Stover in a statement. "The ability to now market our combination test on a national basis represents a significant milestone for our thyroid franchise and company overall."