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Assays are available as part of pre-developed panels:
An extensive range of pre-developed validated tests are available to help companies better understand the metabolism, efficacy and safety of new medicines. These tests include cytochrome P450 genes, UGT and others.
Assays to detect a known gene variant that will predict a patient’s response to a specific drug. For example assays for ApoE and MCIR.
We can provide custom developed tests for your drug or genetic variant of interest. We offer a design, validate and test service, in which any genetic assay will be developed for a customer, validated in line with regulatory guidelines on known samples and applied to the samples from the clinical trial. Expert advice is available if you are unsure which SNPs are of significant importance for your drug.
The Value of Genotyping in Clinical Development
Measuring the genetic variation within a clinical trial population can improve the design and increase the value of the trial by:
- Pre-selecting patients most likely to benefit from the proposed therapy
- Reducing the size of the clinical trial by using a defined population with an improved chance of a good response
- Understanding the results of the trial in terms of the individual differences of the trial population
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DxS is ISO9001:2000 certified for the provision of genetic analysis services to the healthcare industry, the services operate according to the principles of Good Laboratory Practice (GLP).
In March 2005 the FDA published a Pharmacogenomics Data Submissions Guidance to Industry, it showed that the FDA has enthusiasm for pharmacogenetic analysis and it specified the regulatory standards that apply.
DxS ensures that the pharmacogenetic data produced for client studies will meet the regulatory requirements for genomic data submission.
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