PDI enters molecular diagnostics market

PARSIPPANY, N.J.—PDI Inc., a healthcare commercialization company, has 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. The 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.

The 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. PDI paid $8 million in upfront cash, and the terms of the deal include future commercial milestone-based payments and royalties.

The literature indicates that 20 percent to 30 percent of thyroid biopsy samples obtained through fine needle aspiration (FNA) are considered indeterminate following cytological analysis. 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 recommended by the American Thyroid Association to detect genetic alterations that are associated with thyroid cancer.

MiRInform Thyroid 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. MiRInform Thyroid is currently on the market and generated approximately $2 million of revenue over the past 12 months. More than 525,000 FNAs are performed annually in the United States for suspected thyroid cancer, one of the fastest-growing cancers in the U.S.

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.

“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 of PDI. “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.”

“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.”

MiRInform Pancreas is expected to aid physicians in differentiating between the benign condition of chronic pancreatitis and pancreatic cancer in solid masses by measuring expression levels of five microRNAs in pancreatic masses. More than 49,000 expected new pancreatic cancer diagnoses are expected in 2014 in the United States.

PDI is a leading healthcare commercialization company providing 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 is a provider of outsourced pharmaceutical, medical device and diagnostics sales teams, and its Group DCA division is, the company says, “a pioneer in insight-driven digital communication services and integrated multichannel message delivery.”