Immunoassay Testing System provides cardiac diagnostics.

Press Release Summary:



Suited for point-of-care testing environments, Roche Cardiac 200 lateral flow immunoassay testing system provides quantitative cardiac marker test results on whole blood samples with turnaround time of 10-19 min, to help meet best practice guidelines for emergency department settings. Featuring touchscreen and modular configurations, system processes up to 36 tests/hr and offers full cardiac marker menu that includes NT-proBNP, Troponin I (TnI), CKMB, and Myoglobin.



Original Press Release:



Roche Cardiac 200 Offers Rapid Cardiac Diagnostics for the Point of Care



Device provides fast test results for ER clinicians with lab-like accuracy and reliability

INDIANAPOLIS, July 22 /-- Roche Diagnostics announced today the introduction of the Roche Cardiac 200, a comprehensive testing solution for rapid cardiac diagnostic needs in point-of-care testing environments.

The latest addition to an expanding portfolio of Roche Diagnostics cardiac solutions, the Roche Cardiac 200 is a lateral flow immunoassay testing system designed to provide quantitative cardiac marker test results on whole blood samples with a turnaround time of only 10 to 19 minutes, to help meet best practice guidelines for emergency department settings.

Patients who present to the emergency department (ED) with symptoms of a cardiovascular event are typically tested for a series of "cardiac markers," or chemicals that the body releases as an indication of recent heart damage or potential cardiovascular problems. Often the ED physicians treating these patients cannot afford to wait for traditional testing methods, which can take longer than 60 minutes.

The Roche Cardiac 200 can process up to 36 tests per hour and offers a full cardiac marker menu that includes NT-proBNP, Troponin I (TnI), CKMB and Myoglobin. The instrument uses a unique internal corrected fluorescence measurement technology to deliver accuracy and reliability that are consistent with the performance expectations of laboratory systems as defined by the National Academy of Clinical Biochemistry (NACB).(1) Studies have shown that Roche Cardiac 200 diagnostic results for NT-proBNP and Troponin I are essentially equivalent to core lab results. (2, 3, 4)

The Roche Cardiac 200 offers an easy-to-read touch screen and flexible modular configurations to enable labs to address specific workflow needs. It also uses a proprietary internal standard that eliminates the need for routine recalibration.

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 2008, sales by the Pharmaceuticals Division totalled 36.0 billion Swiss francs, and the Diagnostics Division posted sales of 9.7 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interest in Chugai, and invested nearly 9 billion Swiss francs in R&D in 2008. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at www.roche-diagnostics.us.

All trademarks used or mentioned in this release are protected by law. RAMP is a trademark of Response Biomedical Corporation.

(1) Christenson R. The National Academy of Clinical Biochemistry. Laboratory Medicine Practice Guidelines: Biomarkers of acute coronary syndrome and heart failure. 2007.

(2) Lee-Lewandrowski E, Januzzi J, Greene S, Tannous B, Wu A, Smith A, Wong A, Murkami MA, Kaczmarek J, Apple F, Miller W, Hartman K, Jaffe A. Multi-Center Validation of the Response Biomedical Corporation RAMP NT-proBNP Assay with Comparison to the Roche Diagnostics Gmbh Elecsys proBNP Assay 2007; 386:20-24. The Roche Cardiac 200 was formerly known as the RAMP system from Response Biomedical Corporation.

(3) Offner M, Winckel E, Jung A, Lamy T, Arthur G, Zucker M. Clinical Comparison for Exclusion of Acute Heart Failure Using the RAMP and Dade Dimension RxL NT-proBNP Assays. Annual Meeting and Clinical Lab Expo, 2007. The Roche Cardiac 200 was formerly known as the RAMP system from Response Biomedical Corporation.

(4) Wu AHB, Smith A, Christenson RH, Murakami MM, Apple FS. Evaluation of a Point-of-Care Assay for Cardiac Markers for Patients Suspected of Acute Myocardial Infarction. Clin Chim Acta 2004;346:211-219 [b].

CONTACT: Doyia Turner, Corporate Communications of Roche Diagnostics Corporation, +1-317-521-7252, +1-317-694-0335 (cell), doyia.turner@roche.com

Web Site: http://www.roche.com/

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