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ROCHE DIAGNOSTICS INTRODUCES EASY-TO-USE QUALITY CONTROL STRIPS FOR THE ROCHE CARDIAC™ READER

Indianapolis, Indiana -- June 26, 2002 -- Today Roche Diagnostics announced the availability of CARDIAC Reader IQC for use with the Roche CARDIAC Reader. CARDIAC Reader IQC is a set of reusable control strips for fast, easy verification of Roche CARDIAC Reader system performance.

The Roche CARDIAC Reader makes it possible for emergency room and other patient care facilities to obtain quantitative troponin T results in just 12 minutes and myoglobin results in eight minutes. These results provide important information to help physicians identify myocardial damage, determine appropriate therapy, and assess prognosis, even in patients whose electrocardiogram (ECG) is normal.

The timely availability of troponin T results is particularly significant in light of guidelines issued by the American College of Cardiology (ACC)/American Heart Association (AHA) task force on the diagnosis and treatment of patients with known or suspected cardiovascular disease. According to ACC/AHA guidelines, biomarkers of cardiac injury, in particular cardio-specific troponin, should be measured in all patients who present with chest discomfort consistent with acute coronary syndrome (ACS). Furthermore, the guidelines recommend that results be made available within 30 minutes.

The Roche CARDIAC Reader is an easy-to-use, tabletop system that uses a small sample (150 mL) of whole blood to determine the presence of troponin T and myoglobin, both markers of cardiac damage. An audible alarm and red "positive" LED light provide early warning, even before the 12-minute read cycle is completed, when the troponin T reading climbs above 0.1 ng/mL.

One of the key features of the Roche CARDIAC Reader is that it is standardized to the Roche Elecsys® immunoassay system used in the central lab. This allows clinicians to effectively trend quantitative results at the bedside with central lab results after admission. The Roche CARDIAC Reader is the only system truly designed for bedside use that offers this important benefit. "With the Roche CARDIAC Reader, the doctor and patient both benefit from harmony between the bedside test and the central lab," noted Kent Lewandrowski, M.D., director of core labs at Massachusetts General Hospital in Boston.

"The Roche CARDIAC Reader is ideally suited for emergency rooms, where quick turnaround time puts crucial patient information in a doctor's hands quickly," commented Christopher de Filippi, M.D., associate professor of cardiology at the University of Maryland Medical Center in Baltimore. "Clinical studies have shown that positive cardiac troponin T results are an indicator of myocardial damage. The earlier you start therapy on these patients, the greater the benefit."

"Knowing there is damage is reason enough to start antiplatelet therapy," noted Michael Hudson, M.D., staff cardiologist and associate director of the Cardiac Intensive Care Unit at Henry Ford Hospital in Detroit, Michigan. "The Roche CARDIAC Reader combines two powerful and sensitive tests to help triage chest pain patients."

A clinical trial, c7E3 Fab Antiplatelet Therapy in Unstable Refractory Angina (CAPTURE), demonstrated that "the serum troponin T level … identifies a high-risk subgroup of patients with refractory unstable angina suitable for coronary angioplasty who will particularly benefit from antiplatelet treatment with abciximab" (N Engl J Med. 1999;340:1623-1629). In the Platelet Receptor Inhibition in Ischemic Syndrome Management (PRISM) trial, the investigators concluded that the cardiac troponin levels "reliably identified high-risk patients with acute coronary syndromes … who would benefit from tirofiban" (Lancet. 1999;354:1757-1762).

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics, and vitamins. Roche's products and services address prevention, diagnosis, and treatment of diseases, thus enhancing well-being and quality of life. Roche's Diagnostics Division, the world leader in in-vitro diagnostics with a uniquely broad product portfolio, supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals, and laboratories worldwide. Roche Diagnostics Corporation, based in Indianapolis, is the North American headquarters for the diagnostics business of the company. Roche Diagnostics' website is located at www.roche-diagnostics.com.

CARDIAC and ELECSYS are trademarks of a member of the Roche Group.

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