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OMAHA, Neb.—Of the vast array of cardiovascular drugs available, what factors influence the choice of the right drug or the right dosage? Two companies are betting on the effectiveness of CardioPredict, a molecular diagnostic (MDx) test, to find out and thereby facilitate personalized medicine for cardio patients.
Developed by Transgenomic Inc., CardioPredict is a broad-based genetic assay that identifies a patient’s specific genes that influence the effectiveness and safety of many commonly used cardiovascular drugs, predicting how individual patients may respond to cardiovascular drugs such as anticoagulants (blood thinners), statins (cholesterol-lowering drugs), antiarrhythmics and beta- blockers. The test screens for 40 genetic variants in 10 genes and is said to be the only test that can do that. Transgenomic signed a U.S. collaboration agreement with Parsippany, N.J.-based PDI Inc., a healthcare commercialization company that provides multichannel message delivery, to commercialize the test.
The collaboration agreement calls for PDI to be responsible for all U.S.-based marketing and promotion of CardioPredict, and for Transgenomic to be responsible for processing the test in its state-of-the- art CLIA lab and to provide all customer support. Both parties will bear the cost of their expenses and split the profits, but PDI will provide Transgenomic with funding support to mitigate working capital requirements.
Transgenomic, a global biotechnology company advancing personalized medicine in cardiology, oncology and inherited diseases, develops “highly innovative tests using DNA, RNA and proteins to measure genetic variations to suggest diagnosis and treatment of diseases,” according to Nancy Lurker, CEO of PDI. “The company also has an effective and efficient CLIA lab.”
Lurker says Transgenomic fits with PDI’s strategy of looking for science-based companies “that don’t have the resources to commercialize their tests and that require messaging to patients and physicians in an impactful, innovative manner.” She adds that such companies add “more predictable, higher growth areas to PDI, and good reimbursement is predicted,” and she expects reimbursement of $1,000 to $1,100 per test, assuring high revenue.
“Transgenomic’s highest priority over the near term is to maximize the commercial potential of our strong molecular diagnostics portfolio and the adoption of strategic partnerships to expand the company’s commercial reach,” says Paul Kinnon, president and CEO of Transgenomic. “The new commercialization agreement with PDI highlights our corporate strategy, which aims to optimize, through channel partnerships, the commercial potential of these strong assets while focusing our internal resources on our areas of strength.”
Kinnon, who assumed his position Sept. 30, emphasizes that CardioPredict represents his company’s commitment to “developing molecular diagnostics that support the advancement of personalized medicine.” He adds, “this type of test panel has become a preferred tool for cardiologists to personalize therapy selection for their patients with heart disease. We believe this will be the most comprehensive cardiology panel on the market. 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. Strategic partnerships such as this one will allow Transgenomic to globally commercialize our novel assays and clinical tests to address the expanding genetics market.”
“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,” Lurker explains. “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. 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.”
This is PDI’s second collaboration in the MDx space this year, according to Lurker, who said the company is pursuing additional opportunities in that area. Transgenomic recently announced a collaboration with PerkinElmer, which fits in with the company’s objectives of “placing significant emphasis and support on new commercialization agreements, developing clinical tests and building our strategy around companion diagnostics using our proprietary high-sensitivity technology while maximizing our own commercialization efforts in the area of rare genetic disorders,” Kinnon concludes.