PARSIPPANY, N.J., Oct. 6, 2016 /PRNewswire/ -- Interpace Diagnostics Group (NASDAQ: IDXG), a provider of molecular diagnostic tests and pathology services, has completed its initial launch of PanDNA®, a new product that stratifies patients' risk of developing pancreatic cancer based on three specific molecular criteria. PanDNA was developed using the Company's proprietary database of results for over 15,000 patients with pancreatic cysts.
Annually, over 170,000 patients in the US are identified with pancreatic cysts via imaging studies and referred by Radiologists to a Gastroenterologist for further risk assessment. PanDNA is designed to aid in this assessment.
PanDNA was developed for those physicians and institutions that can perform and assess various components of the traditional PancraGen™ product themselves, e.g. cytology or Endoscopic Ultrasound (EUS) analysis. For this specific group of Gastroenterologists, many of whom are affiliated with larger academic centers, their primary interest is in obtaining a more thorough understanding of the molecular features associated with their patients' cysts. Interpace's PanDNA assigns risk for a cyst based on an accumulation of three molecular criteria: DNA quantity; an Oncogene Panel; and a Tumor Suppressor Gene Panel. A higher number of findings is an indication of a potentially higher risk prognosis.
The launch of PanDNA is being done in two separate phases. The initial phase, which is already underway, involves members of the Company's Scientific Advisory Board and others who have expressed an interest in using an approach like PanDNA in their own practices. As part of this phase, the Company is requesting physicians to provide feedback on the ordering process, reports, and other aspects of the test. At the same time, the Company is working with The Centers for Medicare & Medicaid Services (CMS) and others to develop policies and practices regarding billing and pricing. With this input incorporated, the final version of the product is anticipated to be launched on or about October 15, which is the start of the Fall American College of Gastroenterology (ACG) conference being held in Las Vegas. In addition, data used to support the development of the PanDNA product will be presented during the ACG meeting.
The core or standard PancraGen™ product, also known as "Integrated Molecular Pathology" (IMP), integrates multiple factors to determine the appropriate status of a given cyst including imaging, cytology, fluid chemistry, and several molecular markers. The combined assessment of these features conducted by the Company's expert molecular pathologists results in a stratification of risk that ranges from benign to aggressive. PancraGen has been offered by the Company since 2008 and has been run on over 27,000 samples. With the addition of PanDNA we anticipate increasing the universe of likely users of our pancreatic testing and services by up to 50% including expanded use of our current PancraGen assay based on initial interest and feedback from our target audience.
"This is an important milestone for Interpace," said Jack Stover, President and CEO of Interpace. "PanDNA represents a key innovation that we believe will be responsive to the market's needs and expand our growing G.I. business."
PancraGEN® is a pancreatic cyst molecular test that, by using a small sample of pancreatic cyst fluid, 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 that complete surgical removal of the pancreas is not possible, pancreatic cancer is considered a leading cause of cancer deaths.
About Interpace Diagnostics Group, Inc.
Interpace Diagnostics 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 three commercialized molecular tests: PancraGen® for the evaluation of pancreatic cysts and assessment of risk of concomitant or subsequent cancer; 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 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 our 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 company's control. These statements also involve known and unknown risks, uncertainties and other factors that may cause 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, our ability to adequately finance the business, our ability to restructure our debt and other obligations, the market's acceptance of our molecular diagnostic tests, our ability to secure additional business and generate higher profit margins through sales of our molecular diagnostic tests, in-licensing or other means, projections of future revenues, growth, gross profit and anticipated internal rate of return on investments. Additionally, all forward-looking statements are subject to the risk factors detailed from time to time in the company's periodic filings with the Securities and Exchange Commission (SEC), including without limitation, the Annual Report on Form 10-K filed with the SEC on March 30, 2016, as amended on April 29, 2016 and June 14, 2016. 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.
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SOURCE Interpace Diagnostics Group