FDA Clears Roche Diagnostics’ Elecsys® PreciControl Tumor Marker
Laboratory control solution can be used for six tumor marker tests

Today, Roche Diagnostics announced that it has received clearance from the U.S. Food & Drug Administration (FDA) for its Elecsys PreciControl Tumor Marker control solution. The tumor marker provides laboratory professionals with the same control for six different tumor marker tests.

The Elecsys PreciControl Tumor Marker control adds to Roche Diagnostics' growing tumor marker portfolio that includes prostate specific antigen, free prostate specific antigen, Alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), CA-15-3 which monitors treatment of breast cancer and recurrences, and CA-125 which monitors the treatment of ovarian cancer.

Because one control can be used with all of the tests, laboratory professionals could see an increase in efficiency and productivity -- there is no need to switch controls in order to run different tests.

Roche Diagnostics has filed a submission with the FDA for its Elecsys CA 19-9 assay, and that submission is pending. Roche has other tumor markers currently in development for the U.S. market.

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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ELECSYS is a trademark of Roche.