Interpace Diagnostics Announces Agreement with ARUP Laboratories
New Agreement Provides Access to Interpace’s Molecular Products
PARSIPPANY, N.J., Dec. 18, 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, today announced that the Company has entered into a Laboratory Services Agreement with ARUP Laboratories, Inc. (ARUP), of Salt Lake City, Utah, whereby ARUP is utilizing Interpace Diagnostics as a laboratory services provider for its menu of molecular testing services. ARUP is a national reference laboratory with one of the broadest test menus in the industry. Terms of the Agreement were not disclosed.
ARUP offers comprehensive diagnostic laboratory testing to a wide array of customers including hospitals, hospital groups, commercial laboratories, GPO’s, and large clinics among others.
Jack E. Stover, President and CEO of Interpace Diagnostics stated, “We are pleased that an organization with a reputation as strong as ARUP’s is making our molecular tests available to their customers. This new contract represents an opportunity to further expand our reach to providers nationwide.”
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.
PancraGEN® is a molecular test for pancreatic cysts that stratifies cysts based on numerous factors including cytology, amylase, CEA, imaging, and molecular including loss of heterozygosity,(LOH), tumor suppressor genes, and DNA quantity and quality. Using a small sample of pancreatic cyst fluid, PancraGen can aid in pancreatic cancer risk assessment. PancraGEN® is 90% accurate according to clinical studies, enabling effective risk stratification of patients. Pancreatic cancer is often difficult to diagnose in early stages and typically spreads rapidly with signs and symptoms appearing when the cancer is significantly advanced. Because of this, and the fact that complete surgical removal of the pancreas is not possible, pancreatic cancer is considered a leading cause of cancer deaths. Pancreatic cancer generally affects older patients. PancraGen is covered by Medicare.
RespriDx differentiates local recurrence of cancer versus new primary cancer formation. It compares the mutational fingerprint of two or more sites of cancer to determine whether the neoplastic deposits are representative of a recurrence of cancer or a new primary (independent) cancer. RespriDx helps define the primary site of formation in relationship to multiple sites of metastatic spread and helps differentiate multi-centric carcinoma from intra-organ spread of one cancer. The test is based on an analysis of loss of heterozygosity using a panel of microsatellite markers in proximity to 16 tumor suppressor genes. Various peer reviewed publications support the use of mutational profiling for this purpose including “Comparative Mutational Profiling in the Assessment of Lung Lesions: Should it be the Standard of Care?” (Annals of Thoracic Surgery, 2010). RespriDx is covered by numerous payers.
Interpace Diagnostics' BarreGen test utilizes the PathFinderTG® platform, which assesses loss of heterozygosity and microsatellite instability mutations of multiple tumor suppressor genes. BarreGen summarizes this genomic instability information as the Mutational Load, enabling physicians to more accurately stratify patients with Barrett's esophagus for risk of progression to dysplasia and cancer. This can allow for more personalized management of the disease, including early intervention to decrease likelihood of the progression to cancer. All patients with Barrett's esophagus are ideal candidates for testing with BarreGen.
About Interpace Diagnostics Group, Inc.
Interpace Diagnostics 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 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; 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 which differentiates local recurrence of lung cancer verses new primary cancer formation. 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 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.
Released December 18, 2017