Interpace Diagnostics Announces Coverage of Molecular Thyroid Testing by Independence Blue Cross
PARSIPPANY NJ, June 20, 2019 (GLOBE NEWSWIRE) -- Interpace Diagnostics Group, Inc. (NASDAQ: IDXG) announced today that its ThyGeNEXT™ and ThyraMIR® tests for thyroid cancer are now covered by Independence Blue Cross (Independence), providing plan benefits coverage for its members who meet established medical criteria for the tests. Independence covers nearly 2.5 million members in Philadelphia and Southeastern Pennsylvania. Interpace’s testing is made available to its members by its strategic partner, LabCorp (NYSE: LH), Independence’s primary lab services provider, through LabCorp’s Dianon Pathology specialty laboratory.
Jack Stover, President and CEO of Interpace, stated, “We are pleased that Independence has established a medical policy and criteria for our molecular thyroid tests, and that these Independence members and their physicians now have cost-effective access to our services.”
Interpace Diagnostics’ tests for thyroid cancer are specifically intended for patients whose initial thyroid nodules biopsy is indeterminate, without a conclusive indication of whether the nodule is malignant or benign. Launched in 2015, ThyraMIR was the first microRNA gene expression classifier that tests for benign and malignant thyroid nodules. MicroRNAs are small, non-coding RNAs that bind to messenger RNA and regulate expression of genes involved in human cancers, including every known subtype of thyroid cancer. ThyraMIR measures the expression of 10 microRNAs.
In early 2018, Interpace Diagnostics launched ThyGeNEXT, providing an expanded panel that includes markers of aggressiveness as well as other markers that provide physicians with insights to assist them make more-informed treatment decisions for patients suspected of having thyroid cancers. 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.
In combination with ThyGeNEXT, ThyraMIR can more accurately identify indeterminate thyroid nodules as malignant or benign compared to standard clinical practice. ThyraMIR reports a qualitative positive or negative result based on the gene expression levels. A positive result indicates a high probability of malignancy whereas a negative result is highly associated with being benign. Test results should always be interpreted with the consideration of other clinical information and should not be solely relied on for diagnosis. The combination of both tests can help ordering physicians improve risk stratification and surgical decision-making when standard cytopathology does not provide a clear diagnosis for the presence of cancer.
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, in 70%-80% of cases in which surgery is performed, the nodule is ultimately determined to be benign. Molecular testing using ThyGeNEXT – ThyraMIR has been shown to reduce the rate of unnecessary surgeries in indeterminate cases.
The American Thyroid Association has reported that approximately 20% of the 525,000 thyroid fine needle aspiration (FNA) biopsies performed on an annual basis in the U.S. are indeterminate for malignancy based on standard cytological evaluation. Patients with those results thus are candidates for ThyGeNEXT and ThyraMIR.
ThyGeNEXT and ThyraMIR are covered by Medicare and a growing list of commercial insurers.
About Independence Blue Cross
Independence Blue Cross is the leading health insurance organization in southeastern Pennsylvania. With our affiliates, we serve nearly 8 million people nationwide. For more than 80 years, we have been enhancing the health and well-being of the people and communities we serve by delivering innovative and competitively priced health care products and services; pioneering new ways to reward doctors, hospitals, and other health care professionals for coordinated, quality care; and supporting programs and events that promote wellness. To learn more, visit www.ibx.com. Connect with us on Facebook at facebook.com/ibx and on Twitter at @ibx. Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association.
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; 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 Interpace Diagnostics’ (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. 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 2018 Annual Report on Form 10-K filed with the SEC and the Company’s 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.
Interpace Diagnostics Contact
Investor Relations
Joe Green – Edison Group
(646) 653-7030
jgreen@ediosngroup.com
Released June 20, 2019