Clinical Genotyping

Clinical trials often include the analysis of a small number (1-30) of SNPs relevant to drug metabolism. These data are used either prospectively — using genotype data to exclude/include patients in a clinical trial or to understand the metabolic potential of clinical trial patients — or retrospectively, by elucidating the pharmacokinetic, pharmacodynamic, safety, tolerability, and efficacy outcomes through genotype/phenotype correlation analysis.

By working closely with our pharmaceutical partners, we have built an excellent reputation for developing complete solutions for all drug safety and efficacy-related clinical genotyping requirements. Beckman Coulter Genomics ensures appropriate study design by providing expert guidance on gene and SNP selection, and by delivering efficient solutions with respect to sample collection, analysis and banking based on a wide range of technology platforms. With over 1,500 in-house developed and validated pharmacogenetic assays and the experience and flexibility to rapidly develop additional assays, we are able to detect most pharmacogenetically relevant polymorphisms.

Beckman Coulter Genomics has performed in excess of 1,500 clinical genotyping studies for our pharmaceutical and biotechnology customers, and analyzed over 150,000 samples. The results of these studies have been successfully reported and used in IND and NDA submissions. Drawing on this expertise, we provide every customer with a detailed report based on our innovative bioinformatics solutions, which can be readily applied for both internal decisions and regulatory purposes.

Global Capability

Beckman Coulter Genomics employs its clinical genotyping platforms and expertise based in Morrisville, North Carolina, and Bernried, Germany, together with its partnership with SinoGenoMax, in Beijing, China, to support clinical studies worldwide.

Experience

Having conducted more than 1,500 genotyping studies to support clinical drug development, we are well positioned to provide value-added genotyping solutions on a global basis in a consistent, high-quality manner.

Quality System

Beckman Coulter Genomics can provide pharmacogenetic data for client studies that will meet the regulatory requirements for genomic data submission.