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Pharmacogenetics

Cytochrome P450 Assay Services

The Cytochrome P450 family of enzymes is responsible for the metabolism of many widely-prescribed and over the counter drugs.  LGC’s assay service provides routine genotyping for well-understood drug metabolising genes such as: CYP2D6, CYP2C9 and CYP2C19.

What we do

For subject selection in clinical trial populations or for determining metabolic activity in patients taking marketed drugs, LGC provides a five-day turnaround time from sample receipt to prediction of phenotype.

Clozapine response test

LGC offers a single test based on the findings of long term studies at the Institute of Psychiatry, Kings College London, which have shown that genetic variation is responsible for individual differences in response to Clozapine treatment.

This test is the first of its kind to be made available in psychiatry. The test reports the predictive likelihood of a patient with treatment resistant schizophrenia responding to Clozapine based on their individual DNA profile. This service is completely confidential and involves a simple mouth-swab from the patient. It provides faster, informed decisions, with the results available to the psychiatrist within five working days.

LGC’s Clozapine response test is currently being used by psychiatrists in UK Mental Health Trusts.

CYP2D6 licensing

In the FDA March 2005 Guidance for Industry Pharmacogenomic Data Submissions, CYP2D6 is particularly noted as an example of a known valid biomarker. This guidance indicates the desirability of the inclusion of test data for CYP2D6 for a variety of drug development submissions.

The most common polymorphisms found in the CYP2D6 gene are the subject of a patent portfolio in the name of Cancer Research UK and exclusively licensed to the University of Dundee. LGC has an exclusive agreement with the University of Dundee to commercialise this technology and any organisation interested in offering CYP2D6 products or services should enquire for options and terms to access these granted patents for key polymorphisms with the CYP2D6 gene.