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Press Release

Horizon Blue Cross Blue Shield of New Jersey to Cover Interpace’s Molecular Thyroid Tests


Posted on: 26 Feb 18

PARSIPPANY, N.J., Feb. 26, 2018 (GLOBE NEWSWIRE) -- Interpace Diagnostics Group, Inc. (NASDAQ:IDXG) (“Interpace” or “the Company”), a fully integrated commercial and bioinformatics company that provides clinically useful molecular diagnostic tests and pathology services for improved patient diagnosis and management,  announced today that Horizon Blue Cross Blue Shield of New Jersey (Horizon BCBSNJ), the oldest and largest health plan in New Jersey covering 3.8 million patients living in the Northeastern United States, has agreed to cover both of Interpace’s molecular-based thyroid tests, ThyGenX® and ThyraMIR®, for its members effective January 9, 2018. 

Horizon BCBSNJ is a health services corporation leading the transformation of innovative, patient-centered health care across New Jersey and their expansive catchment area in the Northeast. Interpace’s ThyGenX and ThyraMIR assays are now covered by Horizon BCBSNJ for thyroid nodules deemed indeterminate by standard cytopathological analysis. 

With the addition of Horizon BCBSNJ’s members, ThyGenX and ThyraMIR are now covered for over 275 million patients nationwide, including through Medicare, Medicare Advantage, and national and regional health plans. This decision, among that of several other Blue Cross Blue Shield plans across the country, follows a recent technology assessment review that found ThyGenX and ThyraMIR have a favorable impact on patient outcomes.

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.

The ThyGenX - ThyraMIR combination represents the only test in the market that includes the rule-in properties of next-generation sequencing of a patient’s DNA and RNA along with the rule-out capabilities of a micro-RNA classifier to provide physicians with clinically actionable test results. Based on current performance, greater than 90% of the Company’s ThyGenX cases are reflexed to ThyraMir for additional assessment.  The Company first launched ThyGenX in 2014 followed by ThyraMIR in April 2015, making both tests available to Endocrinologists, Endocrine Surgeons, and Pathologists throughout the country.  Since then, the Company has conducted over 15,000 ThyraMIR tests for nearly 400 physicians and hospitals nationwide and has initiated 2 studies to further demonstrate the test’s clinical validity and utility, including an ongoing study with a consortium of leading institutions in New York City and a multi-site, national Registry of cases already tested using ThyGenX and ThyraMIR.   

Jack E. Stover, President and CEO of Interpace Diagnostics stated, “Horizon BCBSNJ’s decision to cover ThyGenX and ThyraMIR has now broadened the availability of these assays and is further evidence of the medical necessity and clinical utility of our thyroid tests. We are pleased that Horizon BCBSNJ has joined the growing list of health plans that cover ThyGenX - ThyraMIR and that their more than 3.8 million members will now have access to the benefits we offer.”

About Thyroid Nodules, ThyGenX and ThyraMIR Testing

According to the American Thyroid Association, approximately 20% 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 fully integrated commercial 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 its business, its ability to restructure its liabilities and other obligations, the market's acceptance of its molecular diagnostic tests, its ability to retain or secure reimbursement, 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 its ability to maintain its NASDAQ listing. Additionally, all forward-looking statements are subject to the risk factors detailed from time to time in the Company's filings with the SEC, including without limitation, the Annual Report on Form 10-K filed with the SEC on March 31, 2017 and the amendment on Form 10-K/A filed on April 28, 2017, the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2017 filed with the SEC on November 11, 2017, and the company’s Registration Statement on Form S-1 (333-218140) initially filed with the SEC on May 22, 2017 . 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:
Paul Kuntz – Redchip
paul@redchip.com

GlobeNewswire
globenewswire.com

Last updated on: 27/02/2018

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