Genetic Analysis Services

The genetic analysis services offered by DxS fall into three general categories:

Clinical Genotyping

Assays are available as part of pre-developed panels:

	Drug Metabolism genes 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.
	Drug specific target genes 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.
	Custom develop assays 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

Tumour Mutation Analysis

In the field of cancer, genetic mutations in the tumour can predict a response to oncology drugs. Tumour mutation analysis is technically challenging because of the heterogeneity of the sample. In practice this means that tumour mutation tests must be able to detect mutations even when the majority of the sample is not mutated.
DxS has an oncology test panel that uses ARMS technology, which allows for very sensitive tests that can detect mutations in background of normal cells. Mutations can be detected at a ratio of 1:100 mutant:normal DNA and this allows DxS to detect genetic variation that could not be seen using DNA sequencing methods. This is very valuable in an oncology clinical trial because it can improve the accuracy of detection and allow a better correlation between mutation, prognosis and drug response.

We have a panel of tests for detecting mutations in:

EGFR (including T790M)

K-RAS

B-RAF

DNA Extraction

DxS offer a quality assured DNA extraction service to customers wishing to outsource this timely process.

DxS DNA extraction service process:

1. Sample handling
   DxS extracts DNA from liquid blood, dried blood spots as well as several other sample types, including tissue and buccal swaps. Sample integrity and traceability are ensured using a fully secure Laboratory Information Management System (LIMS). All samples are identified and tracked using barcodes.
2. DNA Extraction
   DxS has extensive validation data to support its DNA extraction service and offers guaranteed yield and purity based on sample type.
3. Normalisation and Quantification
   DNA is supplied in tubes or deep-well plates. 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.
4. Quality Control
   A range of quality control tests can be tailored and performed to suit client specific requirements.
5. DNA Banking
   A secure storage facility is available at DxS if required. Samples can be stored at either -80°C or -20°C. Long term DNA archiving is often done using our SAFEspot cards.

Project Management

Quality System