The GeneChip System 3000Dx (GCS 3000Dx) is has been approved in the European Union for in vitro diagnostic use, enabling clinical laboratories in the EU to analyse microarray diagnostics, such as the Roche AmpliChip CYP450 Test.
Roche Diagnostics developed this test, which looks for genetic variations that can affect drug efficacy and cause adverse drug reactions to help guide treatment selection, in partnership with Affymetrix. It has just been launched onto the market.
The availability of a dedicated instrument system is expected to accelerate the adoption of microarray-based clinical diagnostics, as well as the development of new genotyping and gene expression array-based assays that will help improve patient care and treatment by improving the accuracy of diagnostics and helping to match patients to the most appropriate treatment.
Stephen Fodor, Affymetrix' chief executive, said. "With the availability of microarray-based diagnostics, the healthcare community will now have access to a scalable and affordable technology to analyse the genetics of human disease."
The GCS 3000Dx instrumentation system comprises a scanner, a fluid-handling station and software. It is a variant of a platform that has been used in over 1,000 clinical research publications, but is now configured for diagnostic use in the EU.
The Roche AmpliChip CYP450 Test will allow diagnostic laboratories to identify certain naturally occurring variations in the drug metabolism genes, CYP2D6 and CYP2C19. These variations affect the rate at which an individual metabolises many common drugs used to treat diseases including depression, schizophrenia, bipolar disorder, cardiovascular disease treated with beta-blockers and others.
Knowledge of these variations, when considered with other contributing factors, can help a physician select the best drug and set the right dose for a patient sooner, as well as avoid drugs that may cause the patient to suffer adverse reactions.