Interpace Diagnostics Enters into Agreement with Nationally Renowned Institution

Agreement Covers Both of the Company’s Molecular Thyroid Tests


PARSIPPANY, N.J., May 30, 2018 (GLOBE NEWSWIRE) -- Interpace Diagnostics Group (NASDAQ: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, reported today that the Company has entered into an Agreement with Vanderbilt University Medical Center (VUMC) based in Nashville, TN, one of the largest and most prestigious academic medical centers in the country. The new Agreement between Interpace and VUMC enables all physicians across the Vanderbilt system access to both ThyGenX® (now ThyGeNEXT®) and ThyraMIR® for patients with indeterminate thyroid nodules. 

ThyGeNEXT® – ThyraMIR® represents the only tests in the market that combine the rule-in properties of next-generation sequencing of a patient’s DNA and RNA, with the rule-out capabilities of a micro-RNA classifier to provide physicians with clinically actionable test results. Since 2015, Interpace has conducted over 15,000 ThyGenX® (the predecessor to ThyGeNEXT®) and ThyraMIR® tests for nearly 400 physicians and hospitals nationwide. 

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® (now ThyGeNEXT®) – ThyraMIR® has been shown to reduce the rate of unnecessary surgeries in indeterminate cases.

Jack Stover, President and CEO of Interpace, said, “This Agreement with such a well-regarded institution as VUMC is another strong indication of the increased interest in ThyGeNEXT® and ThyraMIR® for use in improved classification of indeterminate thyroid nodules.” Stover added, “We are pleased that the physicians and patients within the VUMC and its network now have access to our molecular tests for thyroid cancer.”

About Vanderbilt University Medical Center
Vanderbilt University Medical Center is considered one of the nation’s Best Hospitals as ranked by the well-known U.S. News & World Report and is considered the number one Hospital in the State of Tennessee. Managing more than 2.2 million patient visits each year, Vanderbilt is the primary resource for specialty and primary care in hundreds of adult and pediatric specialties for patients throughout Tennessee and the Mid-South. The School of Medicine’s biomedical research program is among the nation’s top 10 in terms of National Institutes of Health peer reviewed funding, receiving more than $550 million in public and private awards during 2016. The Medical Center is the region’s locus of postgraduate medical education, with over 1,000 residents and fellows training in more than 100 specialty areas. Vanderbilt University Adult Hospital and the Monroe Carell Jr. Children’s Hospital at Vanderbilt are recognized each year by U.S. News & World Report’s Best Hospitals rankings as national leaders, with 19 nationally ranked adult and pediatric specialties. Through the Vanderbilt Health Affiliated Network, VUMC is working with more than 60 hospitals and 5,000 clinicians across Tennessee and five neighboring states to share best practices and bring value-driven and cost-effective health care to the Mid-South.

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® (now 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

About Thyroid Nodules, ThyGenX® (and 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 ThyGenX® (and now ThyGeNEXT®) and ThyraMIR®.

ThyGenX® (and now 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.

ThyGenX® (and now 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, and through a proprietary algorithm, provides insight of cancer risk. Both ThyGenX® (and now ThyGeNEXT®) and ThyraMIR® are covered by both Medicare and Commercial insurers.

ThyGeNEXT® is a proprietary new mutational panel for indeterminate thyroid nodules. ThyGeNEXT® includes numerous additional molecular markers, gene mutations, and RNA fusions compared to ThyGenX®. The new product represents a more comprehensive set of indicators to not only identity malignant or benign nodules, but also ascertain aggressiveness and other characteristics.

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 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.

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.

CONTACT:

Interpace Diagnostics Investor Relations
Joe Green – Edison Group
(646) 653-7030
jgreen@edisongroup.com
Andrew Gibson – Edison Group
(646) 653-7719
agibson@edisongroup.com