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Burgess Hill, 25th September 2006

   

New coagulation monitoring system for healthcare professionals


CoaguChek XS Plus system: Results within 1 minute, increased safety and data management features

Roche Diagnostics today announced the launch of its new professional coagulation monitoring system, the CoaguChek XS Plus, for Prothrombin Time/International Normalised Ratio (PT/INR) [1] monitoring in the UK. Specifically designed for healthcare professionals, near-patient coagulation monitoring is made easy and safe in their daily practice, thanks to the instrument’s data management capabilities, its user-friendly design, and in-built safety features.

The CoaguChek XS Plus system is the professional counterpart to the patient meter, the CoaguChek XS system, completing the coagulation monitoring offering from Roche Diagnostics.

Benefits of the CoaguChek XS Plus for healthcare professionals include memory capacity for 500 patients’ results, comprehensive data management, and the possibility of IT connectivity.

The CoaguChek XS Plus system provides fast results, comparable not only to traditional laboratory results, but also to the ones provided by the patient meter, the CoaguChek XS [2]. Where appropriate, this allows for an easier transition, from physicians testing INR in their practice to patients testing themselves, or even patients managing their own treatment.

The new system gives healthcare professionals high quality information about their patients’ PT/INR results on the spot and is virtually pain-free for the patient, as it does not require any venous blood to be drawn. In case of deviations from the patient’s individual INR therapeutic range, this allows for immediate adjustment of the dose of medication to a level which protects them from potentially life endangering complications, such as thrombosis (excessive clotting) which can potentially result in a stroke, or a hemorrhage (excessive bleeding). Thereby frequent INR monitoring helps to save lives [3].

Each inserted test strip is continuously checked within the measuring channel by the instrument to ensure the correct results are displayed. This new On-board Single-channel System Control (OS2C) feature and other instrument internal quality checks have rendered manual liquid control testing obsolete. Nevertheless, if regulatory requirements do call for it, a liquid control is available to document the quality of results anytime, anywhere.

About CoaguChek products
Since 1994, more than 1.5 million patients around the globe on oral anticoagulant therapy have benefited from INR monitoring with instruments from the CoaguChek family. The CoaguChek XS Plus system represents the third generation of coagulation monitoring devices from Roche Diagnostics for use at the Point of Care, but is the first system specifically developed to meet healthcare professionals’ needs.

About oral anticoagulation therapy
People suffering from a disease such as atrial fibrillation or with a mechanical heart valve, need protection against thrombosis. They are therefore put on life-long anticoagulation therapy (coumarin derivatives = Vitamin K antagonists) in order to thin their blood.
It is important to monitor the therapeutic effects of anticoagulant drugs as each patient reacts differently to them, and to keep potential risks at the lowest possible level. Scheduling the dose of anticoagulants in an optimal way can reduce the incidence of bleeding complications without increasing that of thromboembolic events [3].
Patients conventionally have to go to a laboratory or to their physician’s office, get a venous sample drawn and measured later on. This can take up to several hours or even a few days, potentially delaying the therapeutic decision (adjusting their dosage). The CoaguChek XS Plus system gives healthcare professionals information about their patients’ level of anticoagulation directly on the spot and allows them to adjust - if necessary - the doses of medication to a level which protects the patient from major complications such as thrombosis (excessive clotting) or hemorrhage (excessive bleeding). Studies show that staying within this INR therapeutic range significantly reduces the risk of major complications [3].

About Roche and Roche Diagnostics
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 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 sales by the Pharmaceuticals Division totaled 21.7 billion Swiss francs, 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 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 websites www.roche.com, www.roche-diagnostics.com, www.roche.co.uk, www.roche-diagnostics.co.uk and www.coaguchek.co.uk.

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[1] The "prothrombin time" (PT) measures the coagulability of the blood. It is also measured in a different more standardized unit called "INR"
[2] W. Plesch et al.: Study LB 157-2005; Evaluation of the CoaguChek XS Plus System - Equivalency to the CoaguChek XS System; (http://www.coaguchek.com/com/?target=/com/professionals/news; released on: April 1, 2006)
[3] e.g.: B. Menéndez-Jándula et al.: Comparing Self-Management of Oral Anticoagulant Therapy with Clinic Management; Annals of Internal Medicine. 2005; 142:1-10; Trial EC/00/111/1439 HSCSP., ACOA study
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