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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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