Interpace Diagnostics Presents New Clinical Utility Data at Digestive Disease Week
SAN DIEGO, May 23, 2016 /PRNewswire/ -- Interpace Diagnostics Corp. (NASDAQ: IDXG), 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, announced today at the Annual Digestive Disease Week (DDW) conference the presentation of the results from an analysis of data contained in the National Pancreatic Cyst Registry. DDW is the largest annual gathering of physicians specializing in the treatment of diseases of the digestive tract. The analysis presented supports the significant role the Company's PancraGEN™ test plays in stratifying patients based on their risk of progression to developing pancreatic cancer.
Dr. James Farrell, Director of Yale Center for Pancreatic Disease, led the analysis and is the author of the presentation conducted at the DDW conference. PancraGEN provides assessments for long-term risk of malignancy in pancreatic cystic lesions by examining the cyst's potential for uncontrolled cell growth. Cyst fluid is evaluated for oncogene and tumor suppressor gene mutations and abnormally high levels of DNA in the context of each cysts clinical manifestation.
In the data presented, investigators examined Interpace Diagnostic's large clinical database (>13,000 cases) to assess clinical circumstances in which PancraGEN testing could be of most benefit with management strategies for either surgery or surveillance of patients.
The study concludes that PancraGEN testing can have the highest impact on informing management decisions in cysts with one or two worrisome features observed by first-line testing (i.e. imaging, cytology, or fluid chemistry analysis). Although the clinical manifestations of such cysts were potentially worrisome, PancraGEN results indicated that many (36-83%) were likely at very low risk of malignancy over the next 2-8 years.
The study also shows that PancraGEN can have a high impact on informing management decisions for cysts considered at elevated risk for developing malignancy (i.e. mucinous cystic neoplasms). Mucinous cysts lacking concomitant worrisome imaging features and those with one worrisome imaging feature presented the clinical scenario in which PancraGEN testing could represent the most benefit. Although the clinical manifestation of such cysts was potentially worrisome, PancraGEN results indicated that many (50-73%) were likely at very low risk of malignancy over the next 2-8 years.
"Having this data presented at a prestigious meeting by a luminary in his field is a further demonstration of the value PancraGEN provides physicians in ensuring they make the most informed decision possible when deciding on the best course of action with their patients," commented Jack Stover, Interim Chief Executive Officer of Interpace Diagnostics.
About Digestive Disease Week®
Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW take place May 21-24, 2016, at the San Diego Convention Center, San Diego, CA. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.
PancraGEN™ is a pancreatic cyst molecular test that, by using a small sample of pancreatic cyst fluid, can aid in pancreatic cyst diagnosis and pancreatic cancer risk assessment. PancraGEN is 90% accurate, according to clinical studies, enabling effective risk stratification of patients.
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 three 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 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, 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.. 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, Inc.