Monitor provides point-of-care anticoagulation testing.

Press Release Summary:



Intended for physician's office use and for self-testing by patients on warfarin therapy, CoaguChek® XS System performs onboard quality control in reagent chamber and neutralizes therapeutic levels of heparin and LMW heparin. It provides results in 1 min from 10 µl drop of blood obtained from fingerstick. Performing PT/INR testing at point of care rather than outside lab allows healthcare professionals to make dosage adjustments.



Original Press Release:



New CoaguChek XS System Offers Healthcare Providers Greater Flexibility and Control for Anticoagulation Monitoring at the Point of Care



Next-Generation System FDA-Cleared for Physician's Office Use and Patient Self-Testing

INDIANAPOLIS, Feb. 5 /- Roche Diagnostics announced today that it is introducing the latest advancement in point-of-care (POC) anticoagulation monitoring, the CoaguChek(R) XS System, for physician's office use and self-testing by patients on warfarin therapy.

The exclusive smart technology of the CoaguChek XS System offers new flexibility and control benefits that healthcare professionals can use to manage in-office prothrombin time (PT/INR) testing more effectively. The CoaguChek XS System is the only anticoagulation monitoring system to perform onboard quality control in the reagent chamber, a feature designed to save time and provide enhanced confidence in the quality of results.(1) The system also neutralizes therapeutic levels of heparin and LMW heparin, enabling physicians to do POC testing on a broad range of anticoagulated patients.(1) The latest CoaguChek system also continues to provide accurate, precise results in just one minute from a small 10 uL drop of blood obtained from a fingerstick.(1)

"As a leader in the anticoagulation monitoring industry, Roche Diagnostics continues to deliver innovative products focused on patient safety," said Randy Pritchard, director of Product Marketing and Business Development, Near Patient Testing at Roche Diagnostics Corporation. "With the added features of the CoaguChek XS System, healthcare professionals may bring the many benefits of point-of-care anticoagulation testing to a wider range of patients."

Performing PT/INR (clotting time) 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 them from potentially serious complications. This offers several benefits over laboratory testing with a venous blood sample, a process that can take up to several hours or even a few days, potentially delaying therapeutic decisions.

About CoaguChek products
Physicians have been using CoaguChek instruments for POC PT/INR testing since 1994. Today, in the U.S., four out of five PT/INR tests at the point of care are done using the CoaguChek family of products(2). The CoaguChek XS system represents the third 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 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. Roche employs roughly 70,000 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 worldwide. For further information, please visit our websites www.roche-diagnostics.us and www.roche.com.

(1) CoaguChek XS system package insert. Indianapolis, IN. Roche Diagnostics Corporation, 2007.

(2) Third quarter 2006 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.

CONTACT: Doyia Turner of Roche Diagnostics Corp., +1-317-521-7252, or cell, +1-317-694-0335, or Doyia.turner@roche.com

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

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