Interpace Diagnostics Announces International Expansion of Thyroid Testing

PARSIPPANY, N.J., Jan. 24, 2017 /PRNewswire/ -- Interpace Diagnostics Corp. (NASDAQ: IDXG), a company that provides clinically useful molecular diagnostic tests and pathology services, announced today its most recent entrée into expanding its commercial foot print internationally as a result of the adoption of the ThyGenX test by Dr. Richard Payne of Montreal, Quebec. This is the Company's initial step in launching its Thyroid products in Canada and, if successful, plans are already in place to expand in to other Provinces and work with the Canadian Health Ministry to secure coverage of both ThyGenX®, the Company's oncogene panel assay, and ThyraMir®, the Company's micro- RNA based gene expression classifier.  While the present focus is on ThyGenX, interest in expanding testing to ThyraMir has already been expressed, when additional data becomes available.

Dr. Richard Payne is an associate professor at McGill University in the Department of Otolaryngology - Head and Neck Surgery where his surgical subspecialty is Head and Neck Oncology with a strong emphasis on thyroid cancer. Dr. Payne works at several of the McGill University affiliated adult hospitals including Jewish General Hospital and Montreal General Hospital. Dr. Payne is a leader in the field of thyroid cancer surgery. He is the Director of the Endocrine Surgery Group at the Canadian Society of Otolaryngology - Head and Neck Surgery. He is actively involved in research and presents his work annually at national and international conferences. He has been one of the pioneers in the development of sentinel lymph node biopsy and has published in both North America and Europe on this novel technique. He has been a presenter and moderator to other leading thyroid cancer specialists at the World Thyroid Congress, the Canadian Society of Otolaryngology, and the THANC thyroid course held in New York City, where he provides training to other well-known and highly regarded thyroid cancer specialists.

According to Dr. Payne, "the use of ThyGenX testing in our institution represents an opportunity for us to ensure we are providing the best care to our thyroid patients using all of the most innovative tools and insights available to us." "We have already encountered situations in which the ThyGenX test results helped with patient management decisions."

The Company recently announced the launch of its Thyroid Registry testing study, which will provide data on the real-world effect that both ThyGenX and ThyraMir testing have on physician decision-making and patient outcomes. ThyGenX - ThyraMir represents the only test in the market that combines the rule-in properties of next-generation sequencing of a patient's DNA and RNA with the rule-out capabilities of a micro-RNA classifier to provide physicians with clinically actionable test results. The Company first launched ThyGenX on the next generation sequencing (NGS) platform in November 2014 followed by ThyraMir in April 2015 making both tests available to Endocrinologists and Pathologists throughout the U.S.  Since then, the Company has conducted over 6,000 ThyGenX and ThyraMir tests for nearly 400 physicians and hospitals. 

According to the American Cancer Society, thyroid cancer is the most rapidly increasing cancer in the U.S., tripling in the past three decades. Most physicians have traditionally recommended thyroid surgery where thyroid nodule biopsy results are indeterminate, not clearly benign or malignant following traditional cytopathology review; however, 70%-80% of these surgical outcomes are ultimately benign.  Molecular testing using ThyGenX – ThyraMir has been shown to reduce the rate of unnecessary surgeries in indeterminate cases.

Jack E. Stover, President and CEO of Interpace Diagnostics stated, "We are pleased to continue to expand the reach of our Thyroid products beyond the U.S. market and to be working with an internationally known key opinion leader like Dr. Payne."

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 the Company's 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 the Company's control. These statements also involve known and unknown risks, uncertainties and other factors that may cause the 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, the Company's ability to adequately finance the business, its ability to restructure its debt and other obligations, the market's acceptance of its molecular diagnostic tests, its ability to secure additional business and generate higher profit margins through sales of its molecular diagnostic tests, in-licensing or other means, projections of future revenues, growth, gross profit and anticipated internal rate of return on investments and our ability to maintain our NASDAQ listing.. Additionally, all forward-looking statements are subject to the risk factors detailed from time to time in the Company's periodic filings with the SEC, including without limitation, the Annual Report on Form 10-K filed with the SEC on March 30, 2016, as amended on April 29, 2016 and June 14, 2016, and the Quarterly Report on Form 10-Q filed with the SEC on November 17, 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:
Victor Roberts – RedChip
[email protected]

SOURCE Interpace Diagnostics Corp.