University of Pittsburgh Medical Center

Two companies have agreed to team up to select, validate, and usher novel biomarkers from preclinical trials to the commercialization stage, while offering pharmaceutical companies full testing services from early-stage trials through drug launches.

DakoCytomation (Copenhagen, Denmark) and Pathogenesys (Irvine, CA, USA) announced the agreement at the meeting of the American Association for Cancer Research in Orlando (FL, USA) in March 2004.

DakoCytomation pioneered the concept of pharmacodiagnostics when the company developed the Hercep Test, the first clinical test to assess patients for a specific targeted therapy. Recently, the company received regulatory approval from Switzerland and the U.S. Food and Drug Administration (FDA) for the use of its epidermal growth factor receptor (EGFR) pharmDx kit as an aid in identifying colorectal cancer patients eligible for treatment with cetuximab (Erbitux).

"As a diagnostic company with two pharmDx kits already in routine clinical use, we have proven expertise with regulatory issues, manufacturing, and commercialization,” said Dennis Chenoweth, corporate vice president of diagnostics for DakoCytomation.

Under the agreement, Pathogenesys will provide preclinical support through phase III to pharmaceutical partners leveraging off DakoCytomation's products and services. DakoCytomation will focus its global resources on developing, manufacturing, obtaining regulatory approvals, and commercializing companion diagnostic tests.

"We are excited to partner with a company that will help us achieve the goal of improving the lives of cancer patients,” said James Thompson, M.D., CEO and medical director of Pathogenesys.




Related Links:
DakoCytomation
Pathogenesys