Interpace Diagnostics Announces New Data Supporting Use of BarreGen™, a Molecular Test for Predicting Risk of Progression from Barrett's Esophagus to Esophageal Cancer

PARSIPPANY, N.J., May 18, 2015 /PRNewswire/ -- PDI, Inc. (NASDAQ: PDII) subsidiary, Interpace Diagnostics, announced today new data demonstrating the clinical value of BarreGen™, a molecular diagnostic test for predicting risk of progression from Barrett's esophagus to esophageal cancer approximately three to four years before the cancer develops.

Barrett's esophagus is a condition that occurs when tissue lining the esophagus is replaced by tissue similar to the intestinal lining. It is associated with an increased risk of developing esophageal cancer. The results demonstrate that BarreGen helps differentiate patients at high risk of progression from those at low risk of progression to cancer and well before observable changes in the cells. The data are from a case-control longitudinal study in 69 patients with Barrett's esophagus that show the BarreGen test had an overall accuracy of 95% in identifying patients who progressed to cancer from those who did not progress to cancer. These data were presented at Digestive Disease Week (DDW) in Washington D.C., May 16 – May 19, 2015. DDW is the world's largest, annual meeting of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

"As a patient who suffered from heartburn for many years, I was shocked when I had a sudden onset of more aggressive symptoms that eventually led to a diagnosis of esophageal cancer. An earlier diagnosis could dramatically impact Barrett's and esophageal cancer patients by potentially leading to improved outcomes," said Bart Frazzitta, President of the Esophageal Cancer Education Foundation (ECEF). "The mission of the Esophageal Cancer Education Foundation is to bring about awareness and educate the public about this disease. Making this test available will hopefully mean that fewer patients are ultimately diagnosed with esophageal cancer."

In addition, two other posters will provide data describing the use of PancraGen™ and Interpace Diagnostics' developmental biliary cancer test. The PancraGen poster features the clinical utility of PancraGen based on data from the National Pancreatic Cyst Registry. The biliary cancer test poster describes the added clinical value of using mutational DNA profiling to assess the risk of malignancy in biliary strictures.

"We are excited about the BarreGen data and its potential, as it advances the physician's ability to identify patients at high risk for developing esophageal cancer years before it occurs. This can allow for more personalized patient management strategies and earlier intervention aimed at reducing progression to cancer. Additionally, the analysis of the National Pancreatic Cyst Registry provides insights into the clinical utility of our PancraGen test that is currently available to physicians. Our goal is to continue to develop and bring to market advanced molecular diagnostic tests to help improve patient care and reduce healthcare costs," said Nancy Lurker, CEO of PDI, Inc.

Interpace Diagnostics DDW Poster Details and Links

EMBARGOED UNTIL MAY 16, 2015, 9:30 AM ET

BarreGen: Poster #Sa1923, May 16, 2015 9:30 am – 4:00 pm ET, MyDDW 2015 | Genetic mutations at key loci predict progression to high-grade dysplasia or esophageal adenocarcinoma in Barrett's esophagus 

EMBARGOED UNTIL MAY 18, 2015, 9:30 AM ET

Developmental Biliary Cancer Test: Poster #Mo1373, May 18, 2015 9:30 am – 4:00 pm ET, MyDDW 2015 | Molecular analysis increases the diagnostic yield and sensitivity for malignancy in biliary strictures 

EMBARGOED UNTIL MAY 19, 2015, 9:30 AM ET

PancraGen: Poster #Tu1680, May 19, 2015 9:30 am – 4:00 pm ET, MyDDW 2015 | Management of patients with pancreatic cysts using Integrated Molecular Pathology 

Additional Information About Barrett's Esophagus

Barrett's esophagus is most often diagnosed in people who have long-term gastroesophageal reflux disease (GERD) — a chronic regurgitation of acid from the stomach into the lower esophagus. Barrett's esophagus incidence ranges from 8-20% in these patients and is rising. The condition is diagnosed by the gastroenterologist based on both the appearance of the esophageal lining and the results of tissue biopsies. While only about 0.5% of Barrett's esophagus patients will develop esophageal cancer, once diagnosed with cancer the prognosis can be poor — the 5-year survival rate of esophageal cancer ranges from 4-40% depending on the stage of the cancer at the time of detection. Identification of high-risk patients who can then receive appropriate early intervention is key to improving patient outcomes.

About BarreGen

Interpace Diagnostics' BarreGen test utilizes the PathFinderTG^® platform, a proven assay used in PancraGen, to help assess cancer risk in pancreatic cysts. The PathFinderTG platform assesses loss of heterozygosity and genetic mutations of multiple tumor suppressor genes. BarreGen describes this genomic instability information as the Mutational Load, enabling physicians to more accurately stratify patients with Barrett's esophagus for risk of progression to esophageal cancer. This allows for more personalized management of the disease, including early intervention to decrease the likelihood of progression to cancer. Patients with Barrett's esophagus who benefit most from testing with BarreGen are those requiring clarity with respect to their individual risk for progression to cancer.

About PDI, Inc.

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 November 5, 2014. 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.

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SOURCE PDI, Inc.