Roche has launched the AmpliChip CYP450 microarray in the U.S., the company's first microarray for clinical applications. The product enables clinical diagnostic laboratories to identify certain naturally occurring variations (called polymorphisms) in two genes, the CYP2D6 and CYP2C19, which play a major role in drug metabolism. These variations affect the rate at which an individual metabolizes many drugs used to treat cardiovascular disease, high blood pressure, depression, ADHD, and more. 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 serious adverse reactions. Roche expects the AmpliChip CYP450 microarray-based assay to generate annual revenues of above 100 million US-Dollars by 2008.

"The launch of the AmpliChip CYP450 microarray represents an important milestone in Roche's development of the individualized medicine market," said Heino von Prondzynski, member of the Roche Executive Committee and head of Roche Diagnostics. "Microarray technology, a logical enhancement to our patented PCR technology, is enabling Roche to develop novel diagnostic products that will help physician's move beyond a 'one size fits all' approach to medicine. We remain committed to being the first company to fully develop and commercialize this exciting technology for clinical applications."

"The launch of this product heralds the emergence of pharmacogenetics as a medical and commercial reality," said Stephen P.A. Fodor, Founder, Chairman, and CEO of Affymetrix. "This product, the first of many to come from the Roche and Affymetrix partnership, is a testament to the power of our manufacturing technology to enable new solutions for improved diagnosis and patient care."

Several factors underscore the need to move beyond a one-size-fits all approach to the prescription of drugs. These include the significant percentage of people who fail to benefit from many drugs currently on the market, a significant rate of adverse events, including both serious and unpleasant side effects that can reduce a patient's compliance with the chosen treatment program. The AmpliChip CYP450 microarray represents the first diagnostic-quality tool that offers potential to address these problems, thereby contributing to an improvement in the success of the treatment and patient's quality of life, as well as to a reduction in overall healthcare costs.

Roche developed the AmpliChip CYP450 microarray on the Affymetrix microarray platform, the industry standard for research-use microarrays. In January 2003, the Roche and Affymetrix signed an agreement that gave Roche non-exclusive rights to develop human diagnostic products using core Affymetrix technologies. As part of the agreement, Affymetrix will manufacture Roche's AmpliChip microarrays.

Roche will sell the AmpliChip CYP450 microarray initially as an Analyte Specific Reagent in the United States, for use by CLIA-certified high-complexity laboratories performing CYP2D6 and CYP2C19 genotyping tests. (CLIA, or Clinical Laboratory Improvements Amendments, is a U.S. government agency program to ensure quality laboratory testing.) Roche expects the test to be available as an in vitro diagnostic in the United States and Europe later in 2004.

Roche plans to develop additional microarray-based diagnostic tools in the areas of HIV-1 resistance genotyping, p53 cancer resequencing, colorectal cancer risk prediction, cystic fibrosis, and human papilloma virus genotyping (HPV is the leading cause of cervical cancer). These microarrays will provide information about relevant aspects of an individual's genetic make-up or reveal distinguishing characteristics of the disease or infectious agent itself that can influence choice and duration of therapy. Roche expects these new AmpliChip products to be available by the end of 2004.