- New Agreement for Molecular Thyroid Tests ThyGenX® and ThyraMIR®
PARSIPPANY, N.J., June 05, 2017 (GLOBE NEWSWIRE) -- Interpace Diagnostics Group, Inc. (Nasdaq:IDXG) (“Interpace” or “the Company”), a fully integrated commercial company that provides clinically useful molecular diagnostic tests and pathology services for improved patient diagnosis and management, announced today that the Company has entered into a Laboratory Services Agreement with Einstein Medical Center of Philadelphia (Einstein) to provide expanded laboratory analytical services to Einstein for improved identification of indeterminate thyroid nodules, through Interpace’s combined ThyGenX® and ThyraMIR® molecular tests.
The new Agreement provides access for Einstein’s Endocrinologists, Ear Nose and Throat physicians, and Otolaryngologists to Interpace’s products for thyroid nodules that are initially deemed indeterminate. Nationwide, approximately 20% of thyroid nodules assessed using fine needle aspirate (FNA) biopsies are indeterminate and eligible for further analysis with molecular testing. The American Thyroid Association (ATA) has published guidelines that support the use of molecular testing in those circumstances where traditional cytopathology is indeterminate and unable to differentiate between malignant and benign thyroid nodules.
Einstein Medical Center of Philadelphia is associated with Einstein Healthcare Network, a private, not-for-profit organization with several major facilities and many outpatient centers. Einstein has provided healthcare services for nearly 150 years in the greater Philadelphia region and their primary mission is to provide compassionate, high-quality healthcare to the greater Philadelphia region. Many of the patients their specialists serve are referred by other institutions due to Einstein’s expertise in the area of diagnosing and treating thyroid cancer.
According to Maureen Jordan, VP of Healthcare Services for Einstein, “We are pleased to have reached an Agreement with Interpace to be able to make their products available to our physicians who wish to use them for their patients with suspected thyroid cancer.”
Jack E. Stover, President and CEO of Interpace Diagnostics stated, “We are pleased to have such an impressive organization such as Einstein chose to make our molecular thyroid tests available to their physicians and patients. This new contract continues the strong trend we have seen in the number of new Laboratory Services Agreements we have executed in just the past few months.”
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. Both ThyGenX and ThyraMIR are covered by both Medicare and Commercial insurers.
About Interpace Diagnostics Group, Inc.
Interpace is a 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 three commercialized molecular tests; 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 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.
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 the 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 our ability to maintain our 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 and the Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 filed with the SEC on May 12, 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.
CONTACTS: Interpace Diagnostics Group, Inc. Investor Relations: Paul Kuntz – Redchip paul@redchip.com
