PDI, Inc. Subsidiary Interpace Diagnostics Announces PancraGen™ Benefits Reinforced in Pivotal Study Published in Endoscopy

PARSIPPANY, N.J., Feb. 4, 2015 /PRNewswire/ -- PDI, Inc. (NASDAQ: PDII) subsidiary, Interpace Diagnostics, announced today the publication of results of the pivotal PancraGen™ multicenter clinical validation study in the February 2015 issue of Endoscopy.ⁱ The study concluded that PancraGen (formerly PathFinderTG^®-Pancreas) is 90% accurate at predicting benign and malignant disease in patients with pancreatic cysts, providing important insights into patients' likelihood of pancreatic cancer. These results provide support for using PancraGen to provide more informed management decisions for patients with pancreatic cysts, including whether surgery or surveillance is the most appropriate approach.

This outcome was based on data from the National Pancreatic Cyst Registry, a 492-patient multicenter registry study that followed patients who had PancraGen testing as part of their care when cytological analysis of cyst fluid was inconclusive. Some patients were followed for as long as eight years. The results demonstrate that PancraGen is the most accurate, clinically validated test available for determining risk of malignancy in pancreatic cysts. The manuscript can be accessed at https://www.thieme-connect.de/products/ejournals/html/10.1055/s-0034-1390742.

"The results from this study indicate that PancraGen testing can help healthcare providers make the most appropriate management recommendations for their patients," said Mohammad Al-Haddad, MD, MSc, FASGE, FACG, Director of Endoscopy at Cleveland Clinic Abu Dhabi.

According to Nancy Lurker, CEO of PDI, Inc., "We are pleased a prestigious peer-reviewed publication has reinforced the prior clinical evidence that PancraGen is a highly accurate pancreatic cyst test. PancraGen can help physicians manage their patients with improved technology, leading to better patient treatment decisions and potentially avoiding highly invasive, risky and costly surgery."

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. 

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. The results of the Endoscopy study show that use of PancraGen can help physicians more effectively determine which cysts have low versus high risk of malignancy, providing significant improvements in patient risk stratification compared to approaches recommended by current patient management guidelines.

The Company also announced the rebranding of PathFinderTG-Pancreas as PancraGen and a significant expansion of the national field Sales organization, including new Medical Sales Liaisons (MSLs) with a high degree of clinical expertise and Managed Care Directors who will work with payers to ensure continued coverage of PancraGen. 

PancraGen is currently covered by Medicare and several commercial payers. In addition, the Company has implemented a new Compassionate Assistance Program (CAP) that provides eligible patients with financial assistance to ensure broad access to PancraGen. 

About PDI, Inc.

PDI is a leading healthcare commercialization company providing superior go-to-market strategy and execution to established and emerging healthcare companies through its two core business units. The Company's Commercial Services business unit is a leading provider of outsourced pharmaceutical, medical device and diagnostics sales teams. PDI's Interpace Diagnostics business unit is focused on improving patient care through personalized medicine and molecular diagnostic tests supported by rigorous science. For more information about PDI, Inc. or Interpace Diagnostics, please visit www.pdi-inc.com and www.interpacediagnostics.com.

About PancraGen

Interpace Diagnostics' PancraGen test utilizes the PathFinderTG platform, which assesses multiple tumor suppressor and oncogene DNA abnormalities. PancraGen integrates this DNA analysis with clinical features of pancreatic cysts to accurately stratify patients for risk of pancreatic adenocarcinoma with better accuracy than standard guideline-recommended tests alone. All patients with pancreatic cysts, except those with clear cytological malignancy, are ideal candidates for testing with PancraGen.

Forward-Looking Statements

This press release contains forward-looking statements regarding future events and financial performance. These statements are based on current expectations and assumptions 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, and its subsidiaries', 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. For example, with respect to statements regarding the market's acceptance of Interpace Diagnostics' products, projections of future revenues, growth and profitability, estimated gross profit and anticipated internal rate of return on investments actual results may differ materially from those set forth in this release based on 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 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, including without limitation, PDI's previously filed Annual Report on Form 10-K for the year ended December 31, 2013 and current reports on Forms 10-Q and Forms 8K. 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.

Footnote:

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

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SOURCE PDI, Inc.

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