FDA grants CLIA-waived status to CoaguChek XS Plus system for PT/INR testing at the point of care

Exemption of the system from virtually all CLIA rules gives more labs access to connectivity and data management capabilities for monitoring patients on warfarin therapy

News provided by

Roche Diagnostics

Oct 01, 2012, 11:00 ET

INDIANAPOLIS, Oct. 1, 2012 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted CLIA-waived status to the CoaguChek® XS Plus system, a point-of-care anticoagulation monitor that offers connectivity and data management tools to help healthcare professionals manage PT/INR (blood clotting time) testing. The waiver means that the monitoring technology may now be used in a broader range of clinical settings, such as labs that do not meet the requirements to perform moderate- or high-complexity testing as defined by the Clinical Laboratory Improvement Amendments (CLIA) of 1988.

"The waived status of CoaguChek XS Plus system allows healthcare professionals in CLIA-waived environments access to new tools and connectivity options to help them manage patients on warfarin therapy," said Rod Cotton, senior vice president, professional diagnostics, physician office laboratory, and medical and scientific affairs, at Roche Diagnostics Corporation. "The technology has several features that help ensure fast, accurate results, and the connectivity capabilities help healthcare providers with regulatory compliance, making it easier for them to manage their anticoagulation practices."

The CoaguChek XS Plus system offers the ability to connect and transfer data to IT solutions, including TELCOR QML, RALS-Plus with expanded device configuration capabilities or through the POCT1A standard data transfer protocol. Implementing connectivity with the CoaguChek XS Plus enables data transfer and reporting capabilities to help hospital staff streamline the regulatory compliance process, capture reimbursable costs and improve their organizational efficiency.

The system 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 CLIA-waived tests
CLIA extended federal regulation of laboratory testing to all types of testing sites and based regulation on the complexity of tests, not the type of lab where the testing occurs. The statute established three categories of tests: waived tests, moderate-complexity tests and high-complexity tests. Waived tests -- simple tests with small chance of error or risk -- are exempt from virtually all CLIA rules, so long as testing is performed in strict compliance with the manufacturers' instructions. Moderate- and high-complexity testing, on the other hand, is subject to regulations setting minimum qualifications for all persons performing or supervising these tests, along with corresponding responsibilities for each position in the lab and other requirements. For more information, see www.cms.hhs.gov/CLIA.

About the CoaguChek family of products
Clinicians have been using CoaguChek systems for PT/INR (Prothrombin Time/International Normalized Ratio) testing since 1994. The CoaguChek XS Plus system, which provides results in about a minute and has a 97-percent correlation to lab analyzer results (Dade Sysmex 560), represents the fifth generation of point-of-care anticoagulation monitoring devices from Roche Diagnostics. Today in the U.S., more CoaguChek test strips are sold for point-of-care anticoagulation testing than all other brands combined.

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com or www.roche-diagnostics.us.

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