Interpace Diagnostics Announces Launch of Combination Thyroid Test Study

Patient Registry of ThyGenX and ThyramiR Designed to Further Validate Combination Test's Clinical Utility

 

PARSIPPANY, N.J., Dec. 13, 2016 -- Interpace Diagnostics Corp. (NASDAQ: IDXG), a company that provides clinically useful molecular diagnostic tests and pathology services, announced today that the Company has launched a multi-site study to provide further evidence of the Clinical Utility of the ThyGenX/ThyramiR tests in accurately identifying malignancy or benign status in indeterminate thyroid nodules.  The primary objective of the study is to demonstrate the real world clinical utility of the test, i.e. the degree to which the tests impact physician decision-making and positively affect patient outcomes.  To date, the Company has performed the combination assay on over 5,000 patients on behalf of over 200 physicians and hospitals nationwide. 

Participating institutions, which were selected based on their specific expertise in diagnosing and treating thyroid cancer, include sites from the New York metropolitan region. In September 2016, the Company announced that the New York State Department of Health approved ThyGenX™, the Company's Next Generation Sequencing oncogene panel for indeterminate thyroid nodules, allowing Interpace Diagnostics to offer both ThyGenX and ThyramiR in New York State.  According to Thyroid Disease Manager, New York State accounts for nearly 5% of the approximately 600,000 annual Thyroid FNA biopsies performed in the US.

 

According to Syd Finkelstein MD, Chief Scientific Officer of Interpace Diagnostics, "The role of the participating institutions will be to work with the Company in tracking patients' treatments and other key outcomes data following molecular testing with ThyGenX and ThyramiR.  We expect to be able to report the results of the study sometime during the second half of 2017."        

 

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 rule-out capabilities of a micro-RNA classifier to provide physicians with clinically actionable test results. Based on current performance, over 80% of the Company's total cases are reflexed to ThyramiR for additional assessment.  The Company first launched ThyGenX in October, 2014 and ThyramiR on April 15, 2015 making the combination test available to Endocrinologists and Pathologists throughout the country. 

 

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 be able to collaborate with this group of top tier health care institutions and physicians in the New York market place.  We believe in continuing to invest in studies that provide further evidence that our molecular tests for thyroid cancer provide physicians and their patients critical insights. We expect that the data from this initiative will add to the already compelling evidence supporting the superior performance of ThyGenX and ThyramiR."

 

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, our ability to restructure our debt and other obligations, our ability to find a buyer of our assets, 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 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:

 

Victor Roberts

RedChip Companies

407.644.4256, ext. 111

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