News | October 24, 2013

PDI, Transgenomic Partner to Commercialize Personalized Medicine Molecular Diagnostic Test

Companies enter long-term collaboration advancing test designed for at-risk cardiac patients

October 24, 2013 – PDI, Inc. and Transgenomic, Inc. announced the signing of a U.S. collaboration agreement to commercialize CardioPredict, a molecular diagnostic test developed by Transgenomic. CardioPredict is a broad-based genetic assay which identifies specific genes in patients that influence the effectiveness and safety of many commonly used cardiovascular drugs.

The collaboration was formed to leverage the fast-growing pharmacogenetic testing segment that has exhibited significant expansion over the last several years, particularly in the cardiovascular therapeutic area. Pharmacogenetic tests identify genetic variations that affect drug effectiveness and, as such, assist physicians with drug selection and dosing decisions. The CardioPredict personalized medicine test is well-positioned as the most comprehensive assay that captures a specific set of genes known to influence each individual patient's ability to metabolize commonly used cardiovascular drugs.

Under the terms of the strategic collaboration agreement, PDI will be responsible for all U.S.-based marketing and promotion of CardioPredict, while Transgenomic will be responsible for processing CardioPredict in its state-of-the-art CLIA lab and all customer support. Both parties will bear the cost of their respective expenses and will split profit on a formula basis. In addition, PDI will provide Transgenomic with funding support, principally to mitigate working capital requirements. Other financial terms of the collaboration were not disclosed.

"This collaboration with Transgenomic is another step in our pursuit of commercialization opportunities for clinically valuable products aimed at adding more predictable, higher growth, higher margin businesses that can leverage the substantial full commercialization capabilities of PDI," said Nancy Lurker, chief executive officer of PDI, Inc. "Transgenomic has strong scientific capabilities, an established, efficient and effective CLIA lab and superior patient/physician support infrastructure."

“When launched later this month, we believe that CardioPredict will be the most comprehensive cardiology panel on the market,” said Paul Kinnon, president and chief executive officer of Transgenomic, Inc. “With an experienced sales team and a demonstrated record of success in sales and marketing in the life sciences, PDI is the right partner for the launch and long-term growth of CardioPredict.”

"CardioPredict provides an advanced personalized cardiovascular solution to patients who are taking one or more commonly prescribed cardiovascular drugs in helping them and their physicians better assess how they individually metabolize and respond to these drugs," Lurker continued. "Relative to higher-risk cardiovascular patients being treated within Antiarrythmic, Anticoagulant, Anti-thrombotic, Statin and Beta-blocker drug classes, it is generally acknowledged that there are important genetic variants that significantly influence drug absorption, activation or metabolism/elimination and should be considered when determining drug selection, dosing and monitoring. CardioPredict represents a new personalized tool, with proprietary, patent pending features, to help assure that high-risk cardiovascular patients get the appropriate drug regimen and doses for their unique personal genetic profile. We believe the clinical value to patients is significant. There is a large market, a well-defined patient population and a clearly identified physician base treating these patients that should allow for a very efficient use of PDI's broad base of commercialization capabilities."

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