PDI, Inc. Subsidiary Interpace Diagnostics Enters Molecular Diagnostics Market with Thyroid and Pancreatic Cancer Test Portfolio Acquisition

PARSIPPANY, N.J., Aug. 13, 2014 /PRNewswire/ -- PDI, Inc. (Nasdaq: PDII), a leading healthcare commercialization company, today announced that its Interpace Diagnostics subsidiary has entered the expanding cancer molecular diagnostics market with the acquisition of the miRInform^® Thyroid and Pancreas cancer test assets from privately held Asuragen, Inc. This acquisition marks the execution of PDI's strategy to create a commercially driven molecular diagnostics business and a commitment to developing new solutions for the thyroid and pancreatic cancer testing markets.

MiRInform Thyroid is a diagnostic assay comprised of 17 markers recommended by the American Thyroid Association to detect genetic alterations that are associated with thyroid cancer. MiRInform Thyroid is a clinically useful prognosticator of thyroid cancer, which has demonstrated that the presence of these oncogenic mutations is highly correlated with malignancy with a post-test probability of thyroid cancer of 86 percent.^[i] MiRInform Thyroid is currently on the market and had approximately $2 million of revenue over the past 12 months.

MiRInform Pancreas is a market-ready microRNA test expected to launch in the first half of 2015. This product has demonstrated significant clinical utility in detecting cancer in solid pancreatic tumors in a prospective clinical study.

This transaction includes the miRInform Thyroid and Pancreas tests, intellectual property related to these and other tests in development for thyroid cancer, and an extensive 5,000 plus tissue sample biobank to support life cycle management efforts. Terms of the transaction include $8 million in upfront cash, future commercial milestone-based payments and royalties.

"Today's portfolio acquisition is a pivotal step in PDI's strategy to leverage our extensive healthcare go-to-market experience and infrastructure in the higher margin, high-growth market of molecular diagnostics," said Nancy Lurker, CEO, PDI, Inc. "It also complements our ongoing efforts in thyroid cancer, where a prospective clinical validation study is underway on a previously disclosed test that PDI has rights to in-license. Combined with the acquisition of a much needed, innovative diagnostic in pancreatic cancer – a devastating disease with limited molecular testing options – these tests set Interpace Diagnostics on a path toward establishing a commercial presence in cancer diagnostics."

Twenty to thirty percent of thyroid biopsy samples obtained through fine needle aspiration (FNA) are considered indeterminate following cytological analysis.^[ii] MiRInform Thyroid is used by pathologists and endocrinologists to improve preoperative diagnostic accuracy and aid in the characterization of malignancy for malignant and indeterminate biopsied samples through the analysis of 17 validated genetic alterations.

MiRInform Pancreas is expected to aid physicians in differentiating between the benign condition of chronic pancreatitis and pancreatic cancer in solid masses. Pancreatic cancer determination is often difficult with a significant number of indeterminate diagnoses and up to a 30 percent false negative rate for FNA biopsies. 

About miRInform Thyroid

• More than 525,000 FNAs are performed annually in the U.S. for suspected thyroid cancer^[iii], one of the fastest-growing cancers in the U.S.
• The markers included in the miRInform Thyroid assay are in the American Thyroid Association guidelines with a 'C' recommendation, meaning that it is based on expert opinion.
• MiRInform Thyroid's high positive predictive value for diagnosing cancer is clinically meaningful; as the presence of any oncogenic mutation in patient samples was strongly associated with malignancy and the post-test probability of thyroid cancer was 86 percent.

About miRInform Pancreas

• More than 49,000 expected new pancreatic cancer diagnoses are expected in 2014 in the U.S.^[iv]
• MiRInform Pancreas is expected to aid in the preoperative diagnosis of pancreatic ductal adenocarcinoma by measuring expression levels of five micro-RNAs in pancreatic masses.
• The results of a prospective clinical validation study for this product have been submitted for publication in a peer-reviewed journal and will be available in 2H 2014.

"To better focus on our rapidly growing molecular diagnostic products and translational diagnostic services businesses, Asuragen decided to divest the miRInform assets," said Matt McManus, President and CEO of Asuragen. "PDI will provide commercial leverage for capturing the value of our miRNA technology as it applies to thyroid and pancreatic cancer. We look forward to working with them through this transition as they seek to meet the important diagnostic needs in these disease areas."

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 three core business units. PDI's Interpace Diagnostics subsidiary is working to develop and commercialize molecular diagnostic tests leveraging the latest technology and personalized medicine for better patient diagnosis and management. The company's Contract Sales business unit (CSO) is a leading provider of outsourced pharmaceutical, medical device and diagnostics sales teams. Its Group DCA division is a pioneer in insight-driven digital communication services and integrated multichannel message delivery.

For more information about PDI, Inc. or Interpace Diagnostics, please visit http://www.pdi-inc.com and www.interpacediagnostics.com.

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 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 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 8-K. 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]  Beaudenon-Huibregtse S, et al. Thyroid. [published online ahead of print June 19, 2014]
^[ii] Cooper, D. et al, Thyroid, Volume 16, Number 2, 2006: 109-141
^[iii] Sosa JA, Hanna J, Lanman RB, Robinson KA, Ladenson PW. Increases in thyroid nodule fine needle aspirations, surgeries and diagnoses of thyroid cancer in the United States. American Association of Endocrine Surgeons 34th Annual Meeting, Apr 14-16, 2013. Chicago, Ill. (oral abstract)
^[iv] http://seer.cancer.gov/statfacts/html/pancreas.html

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SOURCE PDI, Inc.