14 New Plans Cover ThyGenX® and ThyraMIR® in 2018 to Date
PARSIPPANY, N.J., May 10, 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, bioinformatics, and pathology services for improved patient diagnosis and management, today announced that 14 Blue Cross Blue Shield plans across the country have published favorable coverage policies since the beginning of 2018 for ThyGenX® and ThyraMIR®, the Company’s molecular tests for indeterminate thyroid nodules. The list of plans includes many of the largest Blue Cross Blue Shield plans in the country, including Blue Shield of California and Horizon Blue Cross Blue Shield of New Jersey, previously announced by the Company. As a result of these 14 new policies, over 75 million members participating in these plans now have coverage for ThyGenX® and ThyraMIR® testing.
Jack Stover, President & CEO of Interpace, said, “We are pleased by the support of the numerous Blue Cross Blue Shield plans broadly picking up coverage of ThyGenX® and ThyraMIR® based largely on our demonstrated clinical utility.” Mr. Stover continued, “We are exceptionally pleased that so many new Blue Cross Blue Shield members will now have the opportunity to experience the benefits of ThyGenX® and ThyraMIR® for indeterminate thyroid nodules, bringing the total number of covered lives to over 275 million people.”
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, approximately 80% of the Company’s ThyGenX® cases are reflexed to ThyraMIR® for additional assessment. The Company launched ThyGenX® in 2014 followed by the launch of ThyraMIR® in April, 2015, making both tests available to Endocrinologists and Pathologists throughout the country. Since then, the Company has conducted over 15,000 ThyGenX® and ThyraMIR® tests for nearly 400 physicians and hospitals nationwide.
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 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 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; ThyGenX® 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 15,000 molecular tests for thyroid nodules. Interpace has been designated by CIO Applications magazine as one of the top 20 companies for providing bioinformatics solutions. 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 www.interpacediagnostics.com
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, 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 history of losses, the Company’s ability to adequately finance the business, 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 SEC filings, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2017, filed on March 23, 2018, Quarterly Reports on Form 10-Q and other SEC filings.
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.