PARSIPPANY, N.J., April 18, 2017 /PRNewswire/ — Interpace Diagnostics Group, Inc. (NASDAQ: IDXG) (the “Company”), a fully integrated commercial company that provides clinically useful molecular diagnostic tests and pathology services, today announced that UnitedHealthcare, the largest health plan in the United States, has agreed to cover Interpace’s ThyraMIR® test used in assessing indeterminate thyroid nodule fine needle aspirate (FNA) biopsies. The coverage is now in effect and is subject to members’ specific benefit plan design. The UnitedHealthcare policy decision is consistent with the National Comprehensive Cancer Network (NCCN) Thyroid Carcinoma Guidelines, which recommend that clinicians consider the use of molecular testing to identify patients with indeterminate cytopathology results whose nodules are actually benign and can thus avoid surgery. Interpace is not currently a contracted, in-network lab provider with UnitedHealthcare. Interpace’s ThyGenX® and ThyraMIR assays are now covered for approximately 250 million patients nationwide, including through Medicare, National, and Regional health plans. Medicare approved coverage for ThyraMIR in January 2016 (LCD L35396).
ThyGenX – ThyraMIR represents the only test in the market that combines the rule-in properties of next-generation sequencing of a patient’s DNA and RNA, with rule-out capabilities of a micro-RNA classifier to provide physicians with clinically actionable test results. Based on current performance, over 80% of the Company’s total cases are reflexed to ThyraMIR for additional assessment. The Company first launched ThyraMIR on April 15, 2015 making it available to Endocrinologists and Pathologists throughout the country. Since then, the Company has conducted over 5,000 ThyraMir tests for nearly 400 physicians and hospitals.
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 Interpace Diagnostics Group, Inc.
Interpace 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 evaluation of pancreatic cysts and assessment of risk of concomitant or subsequent cancer; 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’s mission is to provide personalized medicine through molecular diagnostics and innovation to advance patient care based on rigorous science. For more information, please visit Interpace Diagnostics’ website at www.interpacediagnostics.com.
About Thyroid Nodules, ThyGenX 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 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. ThyGenX and ThyraMIR are covered by both Medicare and Commercial insurers.
Forward Looking Information
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 debt 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. 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.