PARSIPPANY, N.J., March 28, 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 entered into a Laboratory Services Agreement with Acupath Laboratories, Inc. based in Plainview, New York (Long Island) whereby Acupath’s Commercial team will be selling ThyGenX® and ThyraMIR® as part of its menu for Endocrinologists, Endocrine Surgeons, and other physicians focused on the diagnosis and treatment of Thyroid cancer.
Founded in 1998, Acupath is a nationwide provider of in-network, sub-specialized anatomic pathology services focused on the following specialties; Endocrinology, Urology, Gastroenterology, Hematology / Oncology, Dermatology, Breast, Gynecology, Otolaryngology, and Podiatry. Acupath offers an extensive test menu across all service levels (global, TC only, client bill), has over 500 active clients, processes over 150,000 specimens annually, and is one of the leading providers of cutting edge FISH testing, which can assist in the detection and management of bladder cancer, prostate cancer (PTEN ERG), esophageal cancer, breast cancer (HER2), and cervical cancer (TERC). Terms of the Agreement were not disclosed.
Jack E. Stover, President and CEO of Interpace Diagnostics stated, “We are pleased to have another partnership to expand the existing commercialization effort for ThyGenX and ThyraMIR. This new agreement provides Acupath’s clients access to our molecular tests for Thyroid cancer and broadens the network we have created nationwide for our products.”
John Cucci, Chief Sales Officer of Acupath Laboratories concurred, adding, “Acupath is excited about enhancing our strategic partnership with Interpace, enabling physicians across the country to leverage our innovative test menu, personalized customer service, industry best turn-around time, and extensive in-network managed care contracts.”
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 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 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 history of losses, 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 SEC filings, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2017, filed on March 23, 2018, 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.
Paul Kuntz – Redchip