National Plan Coverage for miRNA-based Classifier
PARSIPPANY, N.J., July 26, 2018 (GLOBE NEWSWIRE) -- Interpace Diagnostics Group, Inc. (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 CIGNA, one of the nation’s largest health plan providers, has agreed to cover ThyraMIR®, the first microRNA gene expression classifier for thyroid nodules, as medically necessary.
Interpace previously announced, in 2017, CIGNA’s agreement to cover ThyGenX®, the Company’s next generation sequencing test for thyroid cancer risk assessment. ThyGenX® (now ThyGeNEXT™) and ThyraMIR®, utilized in combination, have both high sensitivity and specificity that corresponds to clinically actionable outcomes in a single testing service. Today approximately 80% of ThyGenX® orders are accompanied by an order for ThyraMIR® testing as well given the performance of the combination testing platform in both ruling in and ruling out cancer. The two tests are billed independently based on Medicare and American Medical Association (AMA) coding policy.
ThyraMIR®, our thyroid cancer miRNA-based classifier, is the first and only microRNA gene expression classifier. mircoRNAs 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. Thyroid cancer develops from the tissues of the thyroid gland and it is a disease in which cells grow abnormally and may potentially spread to other parts of the body. In 2017, the global Thyroid Cancer Treatment market was valued at approximately $340 million and is expected to increase 25.5% percent between 2018 and 2025. See https://sectorhealthcare.com/thyroid-cancer-treatment-market-size-share-analysis-trends-and-forecast-2018-2025acquire-market-research/ for more information on the thyroid cancer market.
CIGNA is one of the largest health plan providers in the United States, with over 20 million members nationwide and their new coverage applies to many of CIGNA’s plans, including commercial and Medicare Advantage plans. Now, instead of reimbursing for ThyGenX® only, CIGNA will also cover ThyraMIR®.
Jack Stover, President and CEO of Interpace, said, “CIGNA’s decision to cover ThyraMIR® along with ThyGeNEXT™ is another significant reimbursement milestone for Interpace.” Mr. Stover continued, “This is especially important because CIGNA is one of the largest health plan providers in the U.S., and so many of our CIGNA covered ThyGeNEXT™ assays reflex to ThyraMIR®, which is now also covered by CIGNA. Not only is this a further market recognition of our first and the only microRNA gene expression classifier; CIGNA’s approval further assures payment and hence availability of our critically important thyroid assays for a large population of plan members who will in turn benefit.” “This policy change reflects an ongoing trend in extending coverage for our diagnostic products among the nation’s largest health plans, helping make our products and services more accessible and affordable to health plan members,” added Mr. Stover.
About Thyroid Nodules, ThyGenX (now ThyGeNEXT) 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 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 Medicare and commercial insurers cover ThyGeNEXT™ and ThyraMIR®.
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; 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 15,000 molecular tests for thyroid nodules. Interpace has been designated 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 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 most recent Annual Report on Form 10-K and 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.
Interpace Diagnostics Group, Inc.
Joseph Green – Edison Group
Andrew Gibson – Edison Group