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Interpace Diagnostics receives New York State approval for thyroid test

Published 05 August 2016

Interpace Diagnostics announced that the New York State Department of Health has reviewed and approved ThyraMir, the Company's micro RNA gene-expression based test, for marketing in New York State.

ThyraMir is used in the classification of indeterminate thyroid nodule results from fine needle aspirates and biopsy specimens. New York State accounts for approximately 5% of the 600,000 Thyroid FNA biopsies performed in the US annually according to Thyroid Disease Manager.

Many States, including New York, Florida, and California require special licensure for laboratory Companies to allow them to provide such tests to patients who reside within their jurisdiction. New York was the final State for which the Company had been awaiting approval.  Even robust submissions with substantial validation study data can take a significant amount of time prior to receiving approval by New York State.   

The Company first launched ThyraMir on April 15th, 2015 making it available to Endocrinologists and Pathologists throughout the country.  Since then, the Company has conducted over 5,000 ThyraMir tests for nearly 400 physicians and hospitals.

According to Jack Stover, President and CEO of Interpace Dignostics, "We are pleased with the New York State acceptance of our data submission for ThyraMir. This is a significant milestone and further confirms the overall robust performance of our test."

The Company has also filed with New York State seeking approval of ThyGenX, our molecular panel that typically precedes the running of ThyraMir to determine whether or not specific biomarkers are present that warrant the reflex to ThyraMir testing. 

Based on current performance, approximately 82% of ThyGenX cases reflex to ThyraMir based on the results of the ThyGenX testing. 

"We believe approval by New York State of ThyraMir is an indicator that our ThyGenX submission will be well received and we subsequently look forward to launching the combination testing of ThyGenX and ThyraMir in the State of New York as soon as possible," commented Stover. 

About Thyroid Nodules, ThyGenX and ThyraMIR testing

According to the American Thyroid Association, approximately 15% to 30% of the 525,000 thyroid fine needle aspirations (FNAs) performed on an annual basis in the U.S. are indeterminate for malignancy based on standard cytological evaluation, and thus are candidates for ThyGenX and ThyraMIR.

ThyGenX and ThyraMIR reflex testing yields high predictive value in determining the presence and absence of cancer in thyroid nodules.  The combination of both tests can improve risk stratification and surgical decision-making when standard cytopathology does not provide a clear diagnosis for the presence of cancer.

ThyGenX utilizes state-of-the-art next-generation sequencing (NGS) to identify more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas, the two most common forms of thyroid cancer.

ThyraMIR is the first microRNA gene expression classifier.  MicroRNAs are small, non-coding RNAs that bind to messenger RNA and regulate expression of genes involved in human cancers, including every subtype of thyroid cancer.

ThyraMIR measures the expression of 10 microRNAs.  Both ThyGenX and ThyraMIR are covered by both Medicare and Commercial insurers. 

Source: Company Press Release