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New Blood Test for Management of Osteoporosis Cleared By the FDA; Roche Diagnostics’ Test Aids Physicians and Patients in Monitoring Disease

November 30, 2005

INDIANAPOLIS, Nov. 30 /PRNewswire/ — A new blood test helps physicians manage their patients’ postmenopausal osteoporosis. The Roche Diagnostics’ Elecsys N-MID Osteocalcin test has now received clearance from the U.S. Food and Drug Administration (FDA) and determines the amount of osteocalcin, a protein found in the bone and in blood serum, which is an indicator of bone formation.

For women with Osteoporosis like Cherrie Burch, a 49-year old woman diagnosed six years ago with low bone mass and taking a weekly biphosphonate, a blood test that can help her and her physician manage her osteoporosis more closely is key.

“Right now, I can only get a bone scan once every two years because of the insurance reimbursement and because it takes that long for the scan to see changes in bone formation through that type of test. I’m diligent about taking my biphosphonate, but it would be nice to see results more frequently,” she said. “Osteoporosis is very prevalent in my family, and I want to do what I can now in order to avoid fracturing a bone in the future.”

“Osteoporosis is a serious, widespread and growing public health threat. The National Osteoporosis Foundation welcomes any new FDA cleared diagnostic options that will help patients address this all too prevalent disease,” said Judith Cranford, Executive Director of the National Osteoporosis Foundation.

Regular monitoring has shown that it can improve a patient’s compliance with their therapy. A recent study on the impact of monitoring on adherence and persistence with treatment for postmenopausal osteoporosis, showed that the group that was tested at 3-month intervals increased their adherence to therapy by 57 percent and stayed on their therapy for 25 percent longer compared to the group with no monitoring.(1)

According to the National Osteoporosis Foundation, osteoporosis and low bone mass currently affects approximately 44 million women and men in the United States, which is 55 percent of all people aged 50 and over. By 2010, the number could increase by another 7 million people.(2)

The U.S. Department of Health and Human Services estimates that 1.5 million people suffer from an osteoporotic-related fracture each year and that one out of every two women over 50 will have an osteoporosis-related fracture in their lifetime.

To test patients with the Roche Diagnostics Elecsys N-MID Osteocalcin test they need to have their blood drawn in the physician’s office or on-site at a laboratory, and it typically takes one to two days for the results.

Roche Diagnostics and Osteoporosis

As part of its market leading bone marker portfolio, Roche Diagnostics also offers the Elecsys Beta-CrossLaps test, a bone resorption marker, which monitors the efficacy of medications that slow or stop the natural process that dissolves bone tissue given to postmenopausal osteoporatic women. Using

the Elecsys Beta-CrossLaps test, physicians can check the efficacy of treatment as early as three months after its introduction. Roche Diagnostics also has the Elecsys PTH test, which determines intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia.

The Elecsys Osteocalcin N-MID test will be available for laboratories in November and should be available for testing of postmenopausal women with osteoporosis by the end of 2005.

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

   ELECSYS is a trademark of Roche.    For more information contact:   Lori LeRoy   Roche Diagnostics   317-521-7159   lori.leroy@roche.com   

1. Clowes et al, Journal of Clinical Endocrinology & Metabolism 89 (3): 1117-1123, 2004.

2. America’s Bone Health: The State of Osteoporosis and Low Bone Mass in Our Nation: The National Osteoporosis Foundation; February 2002.

Roche Diagnostics

CONTACT: Lori LeRoy of Roche Diagnostics, +1-317-521-7159,lori.leroy@roche.com

Web site: http://www.roche-diagnostics.us/http://www.roche.us/http://www.roche-diagnostics.com/




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