Interpace Diagnostics Announces New Analyses Showing Positive Impact of PancraGEN™ in the Clinical Management of Pancreatic Cysts
PARSIPPANY, N.J., Oct. 19, 2015 /PRNewswire/ -- PDI, Inc. (NASDAQ: PDII) subsidiary, Interpace Diagnostics, announced data that were presented in two posters during the American College of Gastroenterology (ACG) Annual Scientific Meeting and Postgraduate Course, October 16-21, 2015, Honolulu, Hawaii. The data presented demonstrated that PancraGEN™ can improve the detection of malignant or highly aggressive pancreatic cysts over current guideline criteria in patient management.
Many pancreatic cyst surgeries are unnecessarily performed in patients with benign disease. Recently released 2015 American Gastroenterological Association (AGA) guideline criteria for managing cystic lesions have proposed to alleviate this problem by suggesting patients meet highly specific clinical criteria for malignancy before surgery is performed. The first poster demonstrates that PancraGEN, a DNA-based molecular diagnostic test for pancreatic cyst risk stratification, provides a more optimal positive and negative predictive value (NPV) for detecting false negatives malignancy than first-line test criteria in the new AGA guidelines. The AGA criteria alone could have <50% sensitivity for malignancy while PancraGEN had a sensitivity of 87%. PancraGEN was better at detecting malignant cysts in those designated as benign by the AGA criteria, thereby decreasing the number of "false negative cases." In this new analysis with PancraGEN there was an increase in sensitivity and NPV without jeopardizing the more optimal PPV for malignancy. This work received one of the prestigious ACG Presidential Poster Awards.
Results of the second analysis show that the use of PancraGEN improved patient outcomes in real-life management decisions. PancraGEN testing benefited patients more than solely relying on International Consensus Guideline (ICG/Sendai) recommended use of imaging, cytology and fluid chemistry results. When the ICG (Sendai) guidelines recommended surveillance but PancraGEN testing indicated these patients were at high risk for pancreatic cancer, 88% of these patients went to surgery within a year and 57% of these patients had malignant outcomes. When the guidelines recommended surgery but PancraGEN indicated low risk for pancreatic cancer, 55% underwent surveillance and 99% had benign outcomes at a median of three years follow up.
"PancraGEN identified nearly 80% of cases of pancreatic malignancy missed by the consensus guideline criteria without drastically over-diagnosing malignancy in patients with benign lesions," said Dr. David Loren, Department of Medicine, Jefferson Digestive Disease Institute, Thomas Jefferson University, Philadelphia, PA. "These analyses show that PancraGEN testing can provide a more optimal approach for detecting the malignant potential of pancreatic cystic lesions and thereby benefit patients and improve outcomes."
According to Nancy Lurker, CEO of PDI, Inc. "We are pleased to see the additional supporting evidence on the value of PancraGEN to patients and physicians, enabling better-informed medical decisions. Pancreatic cancer is a complex disease, and unnecessary pancreatic surgery can lead to serious life-long health complications and even death. These results add to the growing body of evidence demonstrating the value of PancraGEN in helping to balance the need for surgery with risk of malignancy."
Interpace Diagnostics ACG Poster Details and Links
Session Date/Time:
Sunday, October 18, 2015
[2:30 - 4:30 p.m. HST (8:30 - 10:30 p.m. EST)]
Session Date/Time:
Sunday, October 18, 2015
[2:30 - 4:30 p.m. HST (8:30 - 10:30 p.m. EST)]
About Pancreatic Cysts
More than 120,000 pancreatic cysts are detected annually in the U.S. Most of them are identified incidentally by imaging studies targeted at identifying other conditions. Given the high mortality rate associated with pancreatic cancer, it is critical that these cysts are quickly identified as either having low or high potential for malignancy.
About PancraGEN™
PancraGEN™ has 90% i accuracy in stratifying patients for risk of pancreatic cancer with better accuracy than standard guideline-recommended tests alone. PancraGEN utilizes the PathFinderTG® platform to assess multiple tumor suppressor and oncogene DNA abnormalities. The test then integrates this DNA analysis with clinical features of pancreatic cysts. All patients with pancreatic cysts, except those with clear cytological malignancy, are ideal candidates for testing with PancraGEN. PancraGEN provides information that enables physicians to make more informed management decisions for patients with pancreatic cysts, including whether surgery or surveillance is the most appropriate approach. Due to the limitations of standard first-line tests, up to 80% of surgeries on pancreatic cyst patients are potentially unnecessary. Such overtreatment can cause lifelong consequences to patients, including diabetes.
About PDI, Inc. and Interpace Diagnostics
PDI is a leading healthcare commercialization company providing go-to-market strategy and execution to established and emerging pharmaceutical, biotechnology, diagnostics and healthcare companies in the United States through its Commercial Services business, and developing and commercializing molecular diagnostic tests through its Interpace Diagnostics business. PDI's Commercial Services is focused on providing outsourced pharmaceutical, biotechnology, medical device and diagnostic sales teams to its corporate customers. PDI's Interpace Diagnostics is focused on developing and commercializing molecular diagnostic tests, leveraging the latest technology and personalized medicine for better patient diagnosis and management. For more information about us, please visit www.pdi-inc.com.
Forward-Looking Statements
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i Al-Haddad MA, Kowalski T, Siddiqui A, et al.; Integrated molecular pathology accurately determines the malignant potential of pancreatic cysts. DOI: http://dx.doi.org/10.1055/s-0034-1390742; Published online: 14.10.2014; Endoscopy 2015; 47: 136–142; © Georg Thieme Verlag KG; Stuttgart · New York; ISSN 0013-726X
SOURCE PDI, Inc.
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