Interpace Diagnostics Presents New Data on PancraGEN® at DDW
Further Supporting PancraGEN Provides Unique Insights to Physicians
CHICAGO, May 10, 2017 /PRNewswire/ -- Interpace Diagnostics Group, Inc. (NASDAQ: IDXG) (the "Company" or "Interpace Diagnostics"), a fully integrated commercial company that provides clinically useful molecular diagnostic tests and pathology services for improved patient diagnosis and management, announced today the data presented in six posters at this week's Digestive Disease Week (DDW) meeting held May 6th-9th at the McCormick Center in Chicago, Illinois.
The results presented in three of the posters support the clinical utility of PancraGEN® in assessing long-term risk of malignancy in pancreatic cystic lesions and stress the importance of using DNA analysis to better understand risk of cancer in cysts with worrisome imaging or fluid chemistry features that are not definitive for cancer. Together, the results are supported by data from nearly 1000 patients who underwent PancraGEN testing, including 370 patients who had multiple PancraGEN tests over a 4- year period. These results are consistent with the growing body of evidence that suggests PancraGEN provides insights to physicians regarding their patients' risk of cancer that they are unable to glean from traditional parameters.
The results presented in the additional three posters support the clinical utility of PancraGEN as an ancillary test for solid lesions of the pancreas and bile duct using the company's unique method for testing free-DNA obtained from bile duct brushings and fine needle aspirates. Together, the results were supported by data from nearly 350 patients. Notably, a prospective study of 100 patients reported that ancillary PancraGEN testing enhanced detection of cancer by 30% over the use of only traditional cytology testing alone. Furthermore, a study of 232 patients who had PancraGEN testing as part of their standard of care concluded that the use of PancraGEN as an ancillary test to cytology improves diagnostic accuracy for cancer and importantly, impacts physician decision making. Given low risk PancraGEN results, physicians were more likely to recommend active surveillance with higher confidence and had higher consensus for such recommendations.
The results presented were generated by a collaborative group of renowned centers, including:: Washington University, St. Louis, Missouri; University of Colorado, Aurora, Colorado; Arizona Center for Digestive Health, Phoenix, AZ; St Joseph Hospital Medical Center, Phoenix, AZ ; Creighton University School of Medicine; Emory University School of Medicine, Atlanta, GA; Columbia University Medical Center, New York, NY; Yale University, New Haven, CT; University of Southern California, Los Angeles, CA.
The posters presented include:
- "DNA Analysis of Pancreatic Cystic Fluid has Incremental Predictive Value in Assessing Future Risk of Malignant Outcomes"
- "Carcinoembryonic Antigen (CEA) Level in Cyst Fluid of Pancreatic Cyst has Poor Test Reliability and Should not be Used in Categorizing Incidental Pancreatic Cystic Lesions"
- "Being More Confidently Conservative: Mutational Profiling of Non-diagnostic Cytology Samples in Patients with Solid Pancreato-biliary Lesion (SPL) Impacts Clinical Decision Making"
- "PCR Based Mutation Profiling of Free DNA Enhances Cytology and FISH Based Detection of Malignancy in Patients with Biliary Structures Undergoing ERCP: A Prospective Study"
- "Prospective Molecular Mutational Analysis of Stent Supernatant in the Characterization of Benign and Malignant Biliary Strictures, an Interim Analysis"
- "High variability in serial pancreatic cyst fluid characteristics suggests that longer intervals of surveillance may be warranted"
According to Dr. Syd Finkelstein, Chief Medical & Scientific Officer of Interpace, "the results from our ongoing research in collaboration with numerous highly regarded institutions clearly supports the clinical utility of PancraGEN and demonstrates that PancraGEN can have a positive impact on physician decision making providing them a high degree of confidence in their treatment approach."
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 took place May 6-9, 2017, at McCormick Place, Chicago, IL. 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 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 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's mission is to provide personalized medicine through molecular diagnostics and innovation to advance patient care based on rigorous science. For more information, please visit Interpace Diagnostics' 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. 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 filings with the SEC, including without limitation, the Annual Report on Form 10-K relating to our year ended December 31, 2016 filed with the SEC on March 31, 2017. 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
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SOURCE Interpace Diagnostics Group, Inc.
Released May 10, 2017