Your Outsourcing and Clinical Research Partner   > French regulatory requirments       Genomic Variation Enabling Personalized Medicine           The Human Genome Project has provided researchers with a single consensus sequence, which in turn offers the foundation for examination of variations that are medically significant. In addition to mutations, SNPs, haplotypes and gene expression patterns, genomic variations that hold clues to health and disease now include alternative splicing, methylation and gene copy number. These variations are being exploited for diagnostic and therapeutic purposes. Syncitium International is fully committed to employing these variations for the challenge of personalized medicine. We believe these strategies will play key roles in the future of molecular medicine.             Currently available Methods     Implementation                 §        Gene expression analysis §        Mutation analysis §        Methylation Assays §        Genotyping/Haplotyping §        Genome comparison §        BiomarkersTarget Characterization §        Allelic variation §        Alternative splicing §        Disease gene identification §     Impact of multiple gene copies       §        Patient population selection criteria §        Treatment choice guidance §        Prognostic assessment §        Companion diagnostics   For currently available essays please Click Here

Example from our Case Study Library                 ANN: irinotecan         Trade Name: Campto®, Camptosar®, Camptothecan-11®, CPT-11®           Side Effects: Causes severe diarrhea and neutropenia in 20-35% of patients with fatal outcome in ~5%                             Pharmacogenetics: Irinotecan is converted to SN-34, a toxic metabolite inactivated by UGT glucuronidation.   UGT1A1*28 is a variant allele with reduced gene expression and glucuronidation homozygous UGT1A1*28 (7/7 genotype) has 2-4 fold lower glucuronidation than wild-type (6/6 genotype) increased exposure to SN-38                     Safety Pharmacogenomics: Prevalence of grade 4 neutropenia in 59 patients was 9.5%   §          7/7 genotype (6) à 50% §          6/7 genotype (24) à 12.5% §          6/6 genotype (29) à 0%             Conclusion: Should UGT genotyping be used to identify cancer patients predisposed to severe toxicity with irinotecan?                 References:   Rougier et al., Lancet 352:1407-1412, 1998 Saltz et al., NEJM 343:905-914, 2000 Ando et al., Cancer Res 60:6921-6926, 2000 Iyer et al., Pharmacogenomics J 2:43-47, 2002 Innocenti et al., J Clin Oncology 22:1-7, 2004

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