Interpace Diagnostics Announces New Coverage by Blue Cross Blue Shield for Thyroid Testing

The Federal Employee Health Benefit BCBS Program Adds Approximately 5.3 Million Covered Lives

PARSIPPANY, NJ, Nov. 07, 2018 (GLOBE NEWSWIRE) --  Interpace Diagnostics Group, Inc. (NASDAQ: IDXG) announced today that the Blue Cross Blue Shield (“BCBS”) Federal Employee Health Benefit Program (“FEHBP”) has extended coverage of ThyGeNEXT™ and ThyraMIR® to its 5.3 million covered lives including federal employees, retirees and their families. The FEHBP relies on consumer choices among competing private plans to determine costs, premiums, benefits, and service and currently has a 66% federal employee and retiree plan participation rate. This follows the recent trend among numerous BCBS plans to adopt favorable coverage policies for ThyGeNEXT™ and ThyraMIR®.

The ThyGeNEXT™/ ThyraMIR® combination represents the only test on the market that includes rule-in and rule-out properties. The rule-in characteristic utilizes next generation sequencing of the patient’s DNA and RNA along with rule-out capabilities of micro-RNA providing physicians with clinically actionable test results. Based on current performance, over 90% of the Company’s ThyGeNEXT™ cases are reflexed to ThyraMIR® for additional assessment. Interpace has conducted over 25,000 tests for nearly 400 physicians and hospitals nationwide following the initial mutational panel, ThyGenX®, launch in 2014. Earlier this year, the Company launched its next generation mutational panel, ThyGeNEXT™, which represents a more comprehensive set of indicators to not only identify malignant or benign nodules, but also ascertain aggressiveness and other characteristics providing physicians with incremental insights to assist in the treatment decision making.

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 and molecular testing using ThyGenX® / ThyraMIR® has been shown to reduce the rate of unnecessary surgeries in indeterminate cases.

Jack Stover, President and CEO of Interpace, stated, “We are pleased one of the largest national Blue Cross Blue Shield plans now covers our molecular thyroid tests providing these federal employees and their families with access to our thyroid assays.” Mr. Stover continued, “This continues the trend among other Blue Cross Blue Shield plans making our unique ThyGeNEXT™/ ThyraMIR® combination tests available to their members.”

About Thyroid Nodules, ThyGeNEXT™ 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 ThyGeNEXT™ and ThyraMIR®.

ThyGeNEXT™ 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.

ThyGeNEXT™ 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 ThyGeNEXT™ and ThyraMIR® are covered by both Medicare and Commercial insurers with more than 280 million patients covered.

About Interpace Diagnostics Group, Inc.

Interpace is a fully integrated commercial and bioinformatics company that provides clinically useful molecular diagnostic tests, bioinformatics and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for improved patient diagnosis and management. The Company currently has four commercialized molecular tests and one test in a clinical evaluation process (CEP); PancraGEN® for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; ThyGeNEXT™, for the diagnosis of thyroid cancer from thyroid nodules utilizing a next generation sequencing assay; ThyraMIR®, for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay; and RespriDX™ that differentiates lung cancer of primary vs. metastatic origin. 

BarreGEN® for Barrett's Esophagus, is currently being “soft launched” with key opinion leaders as we continue to gather data on this assay that will assist us in seeking favorable reimbursement as well as important clinical information. Barrett's Esophagus is a rapidly growing diagnosis that affects over three million people in the US and over time can progress to esophageal cancer.

The Company’s data base includes data from over 45,000 patients who have been tested using the Company’s current products, including over 25,000 molecular tests for thyroid nodules. Interpace has also been designated as one of the top 20 companies for providing bioinformatics solutions according to CIO Applications magazine, a publication that is known to offer professionals a comprehensive collection of industry trends. Interpace’s mission is to provide personalized medicine through molecular diagnostics, innovation and data to advance patient care based on rigorous science. For more information, please visit Interpace’s website at .

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 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 most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.

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.

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Joe Green – Edison Group

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