Interpace Diagnostics Announces Coverage of Thyroid Testing by Blue Cross Blue Shield of Florida

Florida’s Largest Health Plan Adds Coverage for ThyGenX® and ThyraMIR®

PARSIPPANY, N.J., June 11, 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, today announced that Blue Cross Blue Shield of Florida (“Florida Blue”), the largest health plan in Florida, has agreed to cover Interpace’s combination thyroid molecular-based tests, ThyGenX® and ThyraMIR®.

Jack Stover, President and CEO of Interpace Diagnostics, stated, “We are pleased that the largest payer in the State of Florida, and one of the largest Blue Cross Blue Shield plans in the country, is now covering our molecular thyroid tests.” Mr. Stover continued, “This continues the strong trend we have seen among Blue Cross Blue Shield plans to make our ThyGenX® - ThyraMIR® combination test available to their members.”

Interpace’s ThyGenX® and ThyraMIR® assays are now covered for thyroid modules deemed indeterminate by standard cytopathology analysis for Florida Blue’s more than three million members. Florida Blue, one of the largest independent Blue Cross plans in the U.S., marks the 20th Blue Cross Blue Shield plan since the beginning of 2018 to deem Interpace’s combination thyroid molecular testing with ThyGenX® - ThyraMIR® to be medically necessary when established criteria are met. 

The ThyGenX® - ThyraMIR® combination represents the only test in the market that includes the rule-in properties of next-generation sequencing of the 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 Interpace’s current performance, over 90% of the Company’s ThyGenX® cases are reflexed to ThyraMIR® for additional assessment. Interpace launched ThyGenX® in 2014, followed by ThyraMIR® in 2015, making the combination available to Endocrinologists and Pathologists throughout the country. Since then, the Company has conducted over 25,000 tests for nearly 400 physicians and hospitals nationwide. Recently, the Company announced the launch of ThyGeNEXT™, the next generation of ThyGenX®, providing an expanded panel that now includes markers of aggressiveness as well as other markers that provide physicians with incremental insights to assist in 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. Molecular testing using ThyGenX® - ThyraMIR® has been shown to reduce the rate of unnecessary surgeries in indeterminate cases.

About Thyroid Nodules, ThyGenX® (now 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 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, with more than 280 million patients covered.

About Interpace Diagnostics Group

Interpace Diagnostics is a fully integrated commercial and bioinformatics 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 four commercialized molecular tests; PancraGEN® for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; ThyGenX® (soon to be 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™ for determining lung cancer of origin vs metastatic. 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 2017 Annual Report on Form 10-K filed with the SEC and the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2018 . 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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Source: Interpace Diagnostics Group, Inc.