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.
