News | May 17, 2006
Cost Efficient Solution for Multicenter Cinical Trials
EPIDAUROS Biotechnologie AG offers novel cost efficient solution for high quality genetic testing in multicenter clinical trials
Bernried, Germany - May 17, 2006 - EPIDAUROS Biotechnologie AG, a leading provider of pharmacogenetic solutions located in Bernried near Munich, now offers a novel high quality routine process for genetic testing (genotyping) in multicenter clinical trials using buccal swabs.
Genotyping in multicenter clinical trials is gaining more and more importance since genetic variations in drug metabolism, drug disposition, and drug sensitivity may influence the risk for adverse drug reactions and poor responsiveness of patients. Also regulatory bodies like the U.S. Food and Drug Administration (FDA) are promoting the integration of pharmacogenetics in the drug development process. The careful handling of biological specimens used as a source for DNA extraction is a prerequisite for successful genotyping in such trials. Until now, blood and blood derived samples have often been the only option for applications where significant amounts of DNA are required. However, these samples need to be stored and shipped frozen with a significant impact on related shipment costs.
EPIDAUROS has evaluated alternative and more cost-effective solutions given the strong customer demand in particular related to multicenter clinical trials. These tests have identified the T-Swabs® from Isohelix Ltd. to be a proven valuable and reliable tool providing high DNA yields (of up to 4 µg) with a very low risk for DNA degradation by microbial contamination. DNA extracted from T-Swabs at EPIDAUROS yielded high quality genotyping results.
Michael Lutz, Chief Executive Officer of EPIDAUROS commented: “As EPIDAUROS´ mission is to provide pharmacogenetic solutions for helping to develop better medicines, we were urged by a strong market and customer need to provide more cost-effective alternatives to applications where a high DNA yield is required. With the T-Swabs® we are in a strong position to provide such solution with direct impact on sampling in multicenter clinical trials. While we discuss this new offering with several of our customers, one multicenter genotyping trial is already in preparation.“
Contact EPIDAUROS
Dr. Michael Lutz
Chief Executive Officer
Dr. Hans Peter Arnold
Senior Director
Business Development & Marketing
Phone: +49 (0)8158 9985 0
Fax: +49 (0)8158 9985 48
E-Mail: contact@epidauros.com
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