Interpace Diagnostics Announces Expansion of LabCorp National Agreement

LabCorp’s Dianon Pathology Specialty Laboratory to Provide Cytopathology Services

PARSIPPANY, N.J., March 20, 2018 (GLOBE NEWSWIRE) -- Interpace Diagnostics Group, Inc. (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, today announced that the Company has executed a new agreement with LabCorp (NYSE:LH) to further expand the Company’s national network of cytology providers in support of its Thyroid molecular business unit. The arrangement builds on the parties’ 2016 agreement, which established electronic ordering and result reporting through LabCorp for the Interpace’s proprietary ThyGenX® and ThyraMIR® tests, which can provide physicians and patients with more specific diagnostic information about the presence of thyroid cancer in patients whose initial biopsy does not conclusively indicate whether a thyroid nodule is malignant or benign.

Under the parties’ new agreement, physicians will be able to order both thyroid biopsy analysis and molecular testing from Interpace. Dianon Pathology, a member of the LabCorp Specialty Testing Group, will be available to the biopsy analysis, and in the event of an indeterminate result, Interpace will then perform its molecular tests. In addition, physicians who order thyroid biopsy analysis services from Dianon can request an automatic reflex to Interpace’s tests in the event of an indeterminate biopsy result, in which case Dianon will then automatically refer those samples to Interpace to perform the Company’s proprietary assays, ThyGenX and ThyraMIR. Since Interpace first started offering integrated cytology services to customers, a significant percentage of cases ultimately deemed indeterminate have been referred to Interpace’s molecular testing (ThyGenX and ThyraMIR), providing physicians and patients with greater diagnostic clarity and reduced turnaround times, helping physicians and patients to more quickly learn whether there is a diagnosis of cancer, and allowing treatment to be commenced earlier when necessary.

Interpace’s network integrated cytopathology service providers offer clients a sole source option for managing their thyroid biopsies. Accordingly, Interpace can now provide a broad array of services, including cytopathology, to physicians who most commonly treat patients with thyroid nodules, such as Endocrinologists, Ear, Nose and Throat specialists, Endocrine Surgeons, and Otolaryngologists.  Dianon is the first national provider of cytopathology services to join that network, and LabCorp remains the only national laboratory to offer the Interpace molecular tests, which are now part of the LabCorp test menu. A direct electronic interface between the two companies expedites and simplifies the test ordering process and allows for a test report that provides a comprehensive patient profile using information from both LabCorp and Interpace.

Jack E. Stover, President and CEO of Interpace Diagnostics stated, “We are pleased to incorporate LabCorp and Dianon into our Thyroid cytopathology network, and we believe that both their customers and physicians will find value in working with both organizations.” 

About Thyroid Nodules, ThyGenX and ThyraMIR testing

According to the American Thyroid Association (ATA), 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. Further, the ATA’s published guidelines support the use of molecular testing in those circumstances where traditional cytopathology is indeterminate and unable to differentiate between malignant and benign thyroid nodules.

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. 

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®, 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 also 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.

CONTACTS:
Interpace Diagnostics Group, Inc.
Investor Relations:
Paul Kuntz – Redchip
paul@redchip.com

Released March 20, 2018