Response Genetics Opens European Laboratory for Genetic Analysis of Tumor Specimens
News Jul 04, 2007
Response Genetics, Inc. has announced the opening of an additional laboratory in Edinburgh, Scotland. This is the first in a series of strategically placed global laboratories that the Company plans to open to support the pharmaceutical industry's need for genetic analysis of their global clinical trial specimens.
The Edinburgh laboratory is now open, fully equipped and able to analyze clinical trial specimens for the development of diagnostics and clinical trial sample analysis and conforms to current quality assurance guidelines. With this laboratory and existing U.S. facility in Los Angeles, CA, the capacity within the Company for this analysis has now doubled.
"We are excited to expand our laboratory presence into Europe with the opening of our Edinburgh facility," said Kathleen Danenberg, President and CEO of Response Genetics. "The opening of this new facility is the first step towards implementing the corporate strategy to standardize genetic testing globally. We expect to continue this expansion with the opening of new laboratories in Asia."
Pharmaceutical companies are beginning to develop drugs that will be prescribed to patients whose tumors express specific genetic markers for some specified outcome such as response. The rationale for a movement towards personalized medicine is that the drugs will be more effective in populations of patients whose tumors are genetically susceptible to the particular agent and that the approval process for these drugs will be faster.
Enrollment of patients in a biomarker driven clinical trial sometimes depends on analyzing the tumor specimens for the presence of a particular genetic marker within a few days, which does not provide sufficient time for shipping specimens to the United States. Also, some countries, such as China, have severe limitations on exportation of human specimens. Therefore, it is necessary to have "on site" rapid analysis of clinical trial specimens locally, to effectively compete for patients to complete clinical trials globally.
The goal of global clinical trials is to generate simultaneous approval of drugs around the world; therefore, it is important that the analysis of clinical trial specimens be comparable between these geographically separated sites.
The Company provides an added value to the pharmaceutical industry by offering genetic analysis of clinical trial specimens using the same platform and quality assurance. The Company's use of global laboratories seeks to ensure that the test performs identically around the world and conforms to regulatory agency standards at each site. Therefore, data from various sites can be easily compared internally at the pharmaceutical company and efficiently submitted to the regulatory agencies.
The Company has taken the first step towards fulfilling this need and intends to open other strategically placed laboratories throughout Asia.