Interpace Diagnostics (IDXG) Reports New York State Approval of ThyGenX for Indeterminate Thyroid Nodules

October 5, 2016 8:43 AM EDT
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Interpace Diagnostics Corp. (NASDAQ: IDXG), a company that provides specialized molecular diagnostic tests and pathology services, announced today that the New York State Department of Health has reviewed and approved for marketing ThyGenXâ„¢, the Company's NextGen Sequencing oncogene panel for indeterminate thyroid nodules.

The New York State approval of ThyGenX, which determines whether or not specific biomarkers are present, enables Interpace to market both ThyGenX and ThyraMir together in the state. ThyGenX typically precedes the running of ThyraMir, and they typically go hand in hand with 82% of ThyGenX cases warranting reflex to a more sophisticated, micro RNA assessment via ThyraMir.

According to Thyroid Disease Manager, New York State accounts for approximately 5% of the 600,000 Thyroid FNA biopsies performed in the US annually. Of the several states that require special licensure to provide testing to patients who reside in their jurisdiction, New York was the final state to issue approval.

The Company first launched ThyraMIR in New York State, which holds laboratory companies to some of the highest standards, in April 2015. Approval of ThyGenX was originally filed in 2015 after it was transferred to a NextGen Sequencing platform and an important PIK3CA biomarker was added.

Since November 2014 the Company has conducted over 6,000 combination ThyGenX/ThyraMir tests for over 400 physicians and hospitals outside of New York State.

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

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