(PDII) Positive Impact of PancraGEN™ in Pancreatic Cysts

PARSIPPANY, N.J., Oct. 19, 2015  — 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

POSTER P202: Validation of the AGA 2015 Guideline Criteria for Managing Patients With Pancreatic Cystic Lesions Lacking Frankly Malignant Cytology Results

Session Date/Time:
Sunday, October 18, 2015
[2:30 – 4:30 p.m. HST (8:30 – 10:30 p.m. EST)]

POSTER P203: Integrated Molecular Pathology Impacts Real-Life Management Decisions for Patients With Pancreatic Cystic Lesions

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
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. PDI 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 PDI’s control. These statements also involve known and unknown risks, uncertainties and other factors that may cause PDI’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 market’s acceptance of our molecular diagnostic tests; projections of future revenues, growth, gross profit and anticipated internal rate of return on investments; the loss, early termination or significant reduction of any of our existing service contracts; the failure to meet performance goals in PDI’s incentive-based arrangements with customers; the inability to secure additional business; or our inability to develop more predictable, higher margin business through sales of our molecular diagnostic tests, in-licensing or other means. Additionally, all forward-looking statements are subject to the risk factors detailed from time to time in PDI’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 5, 2015 and in PDI’s Form 10-Q filed with the SEC on May 12, 2015. 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, PDI undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

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