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New Handheld Base Unit for CoaguChek XS Plus System Enables Connectivity to RALS-Plus Data Management Solution for PT/INR Testing at the Point of Care
Date:11/11/2008

Centralized control of anticoagulation meters and data can help healthcare providers decrease costs and improve care for patients on warfarin therapy

INDIANAPOLIS, Nov. 11 /PRNewswire/ -- The U.S. Food and Drug Administration has granted approval for the new Handheld Base Unit for the CoaguChek(R) XS Plus System, which provides connectivity between the anticoagulation meter and the RALS(R)-Plus data management system and enables hospital networks to easily capture, access and manage essential patient, operator and quality data for point-of-care PT/INR (clotting time) testing.

The connectivity capability with RALS-Plus allows for network-wide data management and bi-directional data transfer with anticoagulation meters, which can help point of care (POC) coordinators and others ensure the accuracy of patient records and improve the safety of patients on blood-thinning medications, such as Coumadin(R) (warfarin). The reporting and device management capabilities of RALS-Plus can also help hospital staff streamline the regulatory compliance process, capture reimbursable costs, and improve their organizational efficiency.

When the CoaguChek XS Plus System is docked in the optional Handheld Base Unit, it seamlessly transfers data to the RALS-Plus system through the hospital's information network. The bi-directional data transfer capability allows POC coordinators or other staff to configure individual meter settings from a central location. It also gives them convenient control and management of quality and safety features like operator lockout (to help ensure compliance with certification requirements) and quality control lockouts.

"With the growing influence of Pay for Performance and other quality-based initiatives in healthcare, hospitals are looking for data management solutions to help them reduce costs and improve patient care," said Brian Gunderson, Director of Product Portfolio Management at Medical Automation Systems, which developed the RALS system. "RALS-Plus is designed to do both."

The most significant benefits of connectivity with RALS-Plus relate to enhanced patient safety and quality control, according to Robert Hach, Point of Care Coordinator at Cleveland's MetroHealth System, which has been using RALS-Plus to manage its POC blood glucose testing program for five years and served as a test site for the CoaguChek XS Plus connectivity module. "During the beta test, the connectivity to RALS-Plus allowed us to control the PT/INR meters remotely, so we could manage operator certification and protocol compliance from one location," he says. "That took away any worries about an unauthorized person using the meter, and helped ensure the safety of our patients."

RALS-Plus helps hospitals address quality initiatives by giving them centralized control of point-of-care testing devices, including Roche's ACCU- CHEK(R) Inform system for blood glucose, according to Keith Snyder, Director of IT Marketing at Roche. "Now facilities that use the CoaguChek XS Plus System can extend the benefits of centralized data management to point-of-care testing in their warfarin clinics as well," he said.

The CoaguChek XS Plus System can store up to 500 patient and/or liquid quality control results that can be searched by patient ID, date, and time. It uses two-level, built-in quality controls to help ensure the accuracy of PT/INR test results, but also offers optional liquid quality controls for facilities with policies requiring the use of external quality control measures.

About Anticoagulation Monitoring

Patients with atrial fibrillation, a mechanical heart valve and other conditions often require protection against thrombosis, or blood clots. They are typically put on lifelong oral anticoagulation therapy with Coumadin (warfarin) to thin their blood. Each patient reacts differently to anticoagulant medication, so it is imperative to monitor the therapeutic effects to keep potential risks at the lowest possible level.

About the CoaguChek family of products

Physicians have been using CoaguChek instruments for POC PT/INR (Prothrombin Time/International Normalized Ratio) testing since 1994. Today, in the U.S., more PT/INR tests at the point of care are done using a CoaguChek system than with all other devices combined.(1) The CoaguChek XS Plus System represents the fifth generation of point-of-care anticoagulation monitoring devices from Roche Diagnostics.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of 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 the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders, and diseases of the central nervous system. In 2007, sales by the Pharmaceuticals Division totaled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested more than 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 79,000 people. Additional information is available on the Internet at http://www.roche.com.

About MAS and RALS-Plus

Medical Automation Systems is recognized as the leader in information management for point-of-care testing. For years, the name RALS has been synonymous with point-of-care information management and widely recognized as the leading connectivity system available on the market. Today, more than 1,300 hospitals throughout the country manage their programs with RALS.

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

CoaguChek is a trademark of Roche. RALS is a trademark of Medical Automation Systems. Coumadin is a trademark of Bristol-Myers Squibb Pharma Company.

(1) 4th 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 the GHX Global Healthcare Exchange.

For further information please contact:

Wendy Baker-Stein

Corporate Communications

Roche Diagnostics Corporation

Indianapolis, Ind.

Phone: 317-521-2745

wendy.baker-stein@roche.com


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SOURCE Roche Diagnostics
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