Roche Diagnostics AmpliChip™ CYP450 Test Is Now Available for U.S. Laboratories
First microarray-based diagnostic test for detection of genetic variations that can influence drug metabolism

Roche Diagnostics Corporation announced today that its first microarray-based test, the AmpliChip CYP450 Test, is now available for laboratories in the United States . This test, which is powered by Affymetrix microarray technology, determines a patient's Cytochrome P450 2D6 and 2C19 genotypes from genomic DNA extracted from a whole blood sample. Information about CYP2D6 and CYP2C19 genotype may be used as an aid to clinicians in determining therapeutic strategy and treatment dose for therapeutics that are metabolized by the CYP2D6 or CYP2C19 gene product.

Some clinically relevant drugs categories that are known substrates of CYP2D6 and CYP2C19 enzymes include: antidepressants, beta blockers, anti-psychotics, and some chemotherapy drugs.

“Millions of Americans are currently on medications within these categories and with 25 to 60 percent of them not responding properly to the drugs they were prescribed, it is important that patients know how the drugs are metabolized in their system. Knowing a patient's CYP450 genotype can assist physicians to find the right drug and the right dose for a patient ,” said Tiffany Olson, President and CEO, Roche Diagnostics Corporation. “Information provided by this microarray test may help physicians in impacting the effectiveness of treatment for patients.”

The AmpliChip CYP450 Test was launched in Europe in the fall of 2004 and was cleared for in vitro diagnostics use by the U.S. Food and Drug Administration (FDA) in January. The test combines the strengths of two industry technologies, Roche's patented polymerase chain reaction (PCR) amplification technology, which replicates even minute amounts of genetic material to detectable levels, and Affymetrix high-density microarray technology on glass chips no bigger than a thumbnail arrayed with tens of thousands of precisely arranged DNA fragments. Affymetrix, Inc. announced on December 23rd, 2004 that its GeneChip System 3000Dx instrumentation, on which the AmpliChip CYP450 Test is run, has also received FDA clearance for diagnostic use in the United States .

About Roche and the Roche Diagnostics Division
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-intensive healthcare groups. Its core businesses are pharmaceuticals and diagnostics. As a supplier of innovative products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in Diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004, the Pharmaceuticals Division generated 21.7 billion Swiss francs in prescription drug sales, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Roche’s Diagnostics Division, with a uniquely broad product portfolio, supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide.

Roche Point of Care Diagnostics, a business area of Roche Diagnostics, supplies products and systems for near patient diagnostic testing in hospitals and outpatient settings.

Roche Diagnostics’ North American headquarters is located in Indianapolis, Ind. (www.roche-diagnostics.us) For further information, please visit our websites www.roche.us and www.roche-diagnostics.com

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