FDA Clears Roche Diagnostics Tumor Marker for Pancreatic Cancer Management
New test aids physicians in the management and monitoring of patients

Today, Roche Diagnostics announced that it has received U.S. Food and Drug Administration (FDA) clearance for the Roche Elecsys® CA 19-9 test for the quantitative measurement of the tumor associated antigen for pancreatic cancer. This test will aid physicians in monitoring patients who are receiving treatment for cancers of the exocrine pancreas, which is found in the section of the pancreas that produces enzymes which help with digestion.1 The Roche Elecsys CA 19-9 test provides a broad measuring range, giving physicians confidence in patients’ results.

“The approval of CA 19-9 adds to an already extensive menu of tumor markers, providing Roche Diagnostics customers with a thorough menu of tumor markers for their laboratory,” said Andy Thomson, Senior Vice President, Centralized Diagnostics, Roche Diagnostics. “For the customer seeking an all-inclusive tumor marker test menu combined with broad measuring ranges and high precision, Roche Diagnostics provides a single laboratory solution.”

The measuring range of the Elecsys CA 19-9 test (0.600 - 1000 U/mL), combined with the high precision of the test can help provide more reliable information to physicians, and be used to monitor the patient’s therapeutic response.

This test broadens 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, CA-125 which monitors the treatment of ovarian cancer, and the Elecsys PreciControl Tumor Marker solution.

This assay can be used on the Roche Elecsys® 1010 and Elecsys® 2010 systems, and the MODULAR ANALYTICS E 170 module. All of which will be available in August.

In the United States, pancreatic cancer is the eleventh most common cancer and the fourth leading cause of cancer deaths in men and women on an annual basis. The American Cancer Society predicts that, in 2005, about 32,180 people in the U.S. will be found to have pancreatic cancer and about 31,800 will die of the disease.1

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 and MODULAR are trademarks of Roche.

1. American Cancer Society. Cancer Facts and Figures 2005 . Atlanta , Ga : American Cancer Society; 2005.