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Roche Diagnostics Launches CoaguChek XS Plus System to Provide New PT/INR Point-of-Care Solution for Non-Waived Anticoagulation Services
Date:10/29/2007

FDA-Cleared, Next Generation Coagulation Monitor Offers Both Built-in

Controls, and Optional External Liquid Quality Controls

INDIANAPOLIS, Oct. 29 /PRNewswire/ -- Roche Diagnostics' newly launched CoaguChek XS Plus System offers built-in controls and optional, external liquid controls to help non-waived clinics monitoring anticoagulation ensure accurate PT/INR (clotting time) test results for patients taking blood thinner medication.

The handheld, battery-powered CoaguChek XS Plus System has the ability to store up to 500 patient and or liquid quality control results that can be searched by patient, date and time. The meter also is designed for data management connectivity with patient ID, operator lockout and quality control lockouts.

The CoaguChek XS Plus System is pending CLIA waiver approval by the Food and Drug Administration.

"Coupled with a systematic anticoagulation management approach, the CoaguChek XS Plus System can help physicians and laboratorians provide their patients with the current best practices in warfarin management," said Randy Pritchard, Director of Strategic Marketing for Point of Care Diagnostics at Roche Diagnostics. "That can help them increase their patients' time in therapeutic range, minimize adverse events, and address the new coagulation monitoring requirements in the Joint Commission's 2008 Patient Safety Goals."

Similar to the CoaguChek XS System using the CoaguChek XS PT Test Strip, the CoaguChek XS Plus System performs two levels of onboard quality controls as part of every PT/INR test, all in a single test chamber, a feature designed to save time and provide enhanced confidence in the quality of results. The CoaguChek PT test strip also neutralizes therapeutic levels of heparin and low-molecular-weight heparin, enabling physicians to do point-of-care testing on a broad range of anticoagulated patients. The latest CoaguChek system, with the use of the CoaguChek PT test strip, continues to provide accurate, precise results in just one minute from a small 10 microliter drop of blood obtained from a fingerstick, increasing patient comfort.(1)

The optional external liquid quality controls available as the CoaguChek XS Plus PT Controls include a code chip and eight bottles of liquid quality controls (four level 1 bottles and four level 2 bottles) that allow laboratorians to independently test the CoaguChek XS Plus System.

Performing PT/INR testing at the point of care rather than at an outside lab allows healthcare professionals to make dosage adjustments and talk with patients immediately, to help protect the patients from potentially serious complications. Patient preferred fingerstick testing with a POC device offers several benefits over testing with a venous blood sample, a process that can take up to several hours or even a few days, potentially delaying therapeutic decisions.(1)

About Anticoagulation Monitoring

Patients with atrial fibrillation or a mechanical heart valve require protection against thrombosis, or blood clots. They are typically put on life- long oral anticoagulation therapy of Coumadin(R) (warfarin) to thin their blood. It is imperative to monitor the therapeutic effects of anticoagulant medications as each patient reacts differently to them, and to keep potential risks at the lowest possible level.

About CoaguChek products

Physicians have been using CoaguChek instruments for POC PT/INR testing since 1994. Today, in the U.S., more PT/INR tests at the point of care are done using the CoaguChek family of products than any other device on the market.(2) The CoaguChek XS Plus represents the fifth generation of point-of- care anticoagulation monitoring devices from Roche Diagnostics.

About Roche and the Roche Diagnostics Division

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of diseases, 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 drugs for cancer and transplantation and a market leader in virology. In 2006, sales by the Pharmaceuticals Division totaled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 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 offers a uniquely broad product portfolio and supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our U.S. Web site at http://www.roche-diagnostics.us.

All trademarks used or mentioned in this release are legally protected by law.

(1) Giles TD and Rofidal L. Results of the prothrombin office testing

benefit evaluation (PROBE), Cardiovascular Review and Reports. Vol

XXIII, No. 1, January 2002.

(2) Second Quarter 2007 total market share of projected distributor unit

sales of the Point of Care Testing Coagulation Reagents and Kits

product class by HPIS Market Intelligence, a division of GHX Global

Healthcare Exchange. Total Market includes all market sectors as

defined by HPIS. Physician, Long Term Care, Treatment Centers,

Clinical Laboratory, Hospital, Home Healthcare and Other/Unspecified.

Data on file at Roche Diagnostics.

For further information please contact:

Lori McLaughlin

Corporate Communications

Roche Diagnostics Corporation

Indianapolis, Ind.

Phone: 317-521-3112

lori.mclaughlin@roche.com


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SOURCE Roche Diagnostics
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