Interpace Diagnostics Announces New York State Approval Of Thyroid Test
PARSIPPANY, N.J., Aug. 4, 2016 /PRNewswire/ -- Interpace Diagnostics Corp. (NASDAQ: IDXG), a company that provides clinically useful molecular diagnostic tests and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for better patient diagnosis and management, announced today 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.
About Interpace Diagnostics Group, Inc.
Interpace Diagnostics is a company that provides clinically useful molecular diagnostic tests and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for better patient diagnosis and management. The Company currently has three commercialized molecular tests; PancraGen® for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; ThyGenX, for the diagnosis of thyroid cancer from thyroid nodules utilizing a next generation sequencing assay and ThyraMIR, for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay. Interpace Diagnostics' mission is to provide personalized medicine through molecular diagnostics and innovation to advance patient care based on rigorous science.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to our future financial and operating performance. The company has attempted to identify forward looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond company's control. These statements also involve known and unknown risks, uncertainties and other factors that may cause company's actual results to be materially different from those expressed or implied by any forward-looking statement. Known and unknown risks, uncertainties and other factors include, but are not limited to, our ability to adequately finance the business, the market's acceptance of our molecular diagnostic tests; our ability to secure additional business and generate higher profit margins through sales of our molecular diagnostic tests, in-licensing or other means, projections of future revenues, growth, gross profit and anticipated internal rate of return on investments. Additionally, all forward-looking statements are subject to the risk factors detailed from time to time in the Company's periodic filings with the Securities and Exchange Commission (SEC), including without limitation, the Annual Report on Form 10-K filed with the SEC on March 30, 2016. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.
CONTACTS:
Interpace Diagnostics
Investor Relations:
Dave Schemelia
EVC Group, Inc.
(646)201-5431
dave@evcgroup.com
Doug Sherk
EVC Group, Inc.
(646)445-4800
dsherk@evcgroup.com
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SOURCE Interpace Diagnostics Corp.
