PARSIPPANY, N.J., Nov. 16, 2015 /PRNewswire/ -- PDI, Inc. (NASDAQ: PDII) subsidiary, Interpace Diagnostics, announced today that Novitas Solutions, Inc., the Medicare Administrative Contractor (MAC) for Interpace Diagnostics, has updated its Local Coverage Determination (LCD) for PancraGEN™. The PancraGEN test utilizes the PathFinderTG® platform. The original coverage issued on November 5th, 2010 provided "Coverage with Appropriateness Development," which required the Company to routinely present updated data to further validate the test's effectiveness. The new policy no longer includes this condition for coverage and is effective December 31st, 2015 and ensures continued coverage of PancraGEN for Medicare eligible patients.
This updated coverage was achieved due to the increasing body of evidence including the publication of the results of the pivotal PancraGEN 492 patient multicenter National Pancreatic Cyst registry clinical validation study in the February 2015 issue of Endoscopy.i The study concluded that PancraGEN is 90% accurate at predicting benign and malignant disease in patients with pancreatic cysts, providing important insights into patients' likelihood of developing pancreatic cancer.
Medicare is a major coverage provider for the pancreatic disease market as the incidence of pancreatic cysts is prominent in the over-65 year old population. The Medicare reimbursement rate is expected to remain at its current level of $3,100.
According to Nancy Lurker, CEO of PDI, Inc., "This coverage policy issued by Novitas is another demonstration of the increasing acceptance of the clinical utility of PancraGEN in identifying those patients with pancreatic cysts who truly need surgical intervention. Reducing the number of patients who unnecessarily undergo a highly invasive surgical procedure is consistent with our Company's mission to improve patient outcomes."
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 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 and 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 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 closing of the sale of our CSO business, our ability to adequately finance the business, 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 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
SOURCE PDI, Inc.