Genetic Analysis & DNA extraction
DxS provides genetic analysis services to support Clinical development and enable the delivery of pharmacodiagnostics to support future therapies.
- Our clinical genotyping service is used during drug development to refine and analyse clinical trials.
Our nucleic acid testing services include:
- Pharmacogenetic testing
- Tumour mutation analysis
- DNA Extraction
- Whole Genome Amplification
- DNA Sequencing
- Sample Banking
- Haplotype Tests
- Pharmacodiagnostics
The Value of Genetic Analysis 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 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
The clinical genotyping service provided by DxS is carried out under strict quality guidelines to generate data suitable for inclusion in regulatory submissions. Both the FDA and EMEA are encouraging companies to assess the possible link between genetic variation and the safety and efficacy of new drugs. Data generated by DxS in support of clinical trials meets the requirements for genomic data submission as described in the Guidance to Industry on Pharmacogenomics from the FDA.
DNA Extraction
DNA extraction has typically been a process that the healthcare industry has found to be a burden on resources. The opportunity to outsource this time consuming process to a quality controlled laboratory environment, offers our clients a cost effective solution.
- Sample handling
DxS can extract DNA from liquid blood, dried blood spots as well as several other sample types, including, tissue and buccal swabs. Sample integrity and traceability is ensured using a fully secure Laboratory Information Management System (LIMS). All samples are identified and tracked using barcodes.
- DNA Extraction procedure
The extraction method is tailored to suit our client's needs, dependent on the sample volume, sample content and batch sizes. DxS will undertake the client's own preferred process or we will recommend an appropriate technology.
- Normalisation & Quantification
DNA can be output into tubes or deep-well plates, or daughter dilution plates can be made for direct use by the client.
All samples can be normalised (set to a defined volume or concentration) and quantified, using our in-house validated protocols
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