First Microarray System for Clinical Diagnostics

The system has received the CE Mark for in vitro use.

Called the GeneChip system 3000Dx (GCS 3000Dx), the instrument enables clinical laboratories to analyze microarray diagnostics such as the AmpliChip CYP450 test of Roche Diagnostics (Basel, Switzerland). This test looks for genetic variations that can affect drug efficacy and cause adverse drug reactions. The system comprises a scanner, a fluidics station, and software. It is an extension of the same platform that has been used in more than 1,000 clinical research publications but is now configured for diagnostic use in the European Union.

The product was launched through a partnership between Roche Diagnostics and Affymetrix, Inc. (Santa Clara, CA, USA) via the latter's "Powered by Afffymetrix” program. Under this program, Affymetrix manufactures the microarray and the instruments, while the diagnostic partner develops and commercializes the test. Affymetrix states that this is the first diagnostic microarray system. The company recently received ISO certification.

The AmpliChip CYP450 allows 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 metabolizes many common drugs used to treat diseases, including depression, schizophrenia, bipolar disorder, cardiovascular disease, and others. Knowledge of these variations can help doctors 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.

"Affymetrix is committed to developing tools that will improve the quality of life,” said Stephan P.A. Fodor, Ph.D., chairman and CEO of Affymetrix. "With the availability of microarray-based diagnostics, the healthcare community will now have access to a scalable and affordable technology to analyze the genetics of human disease.”





Related Links:
Affymetrix
Roche Diagnostics