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Indianapolis, Ind., December 11, 2003
Roche Diagnostics Gains FDA Clearance on NT-proBNP for Prognosis
of Congestive Heart Failure and Acute Coronary Syndrome
Clearance Makes Roche Diagnostics the First Company to Provide
Aid in the Diagnosis and Risk Stratification for Congestive Heart
Failure and Acute Coronary Syndrome
In November of 2002, Roche Diagnostics gained Federal Food and Drug
Administration (FDA) clearance on its Elecsys® proBNP immunoassay,
the first fully automated test used for detecting the level of the
NT-proBNP peptide as an aid in the diagnosis of congestive heart
failure (CHF) in patients. Last week, NT-proBNP was cleared by the
FDA for additional claims -- risk stratification in CHF and in acute
coronary syndrome.
This clearance makes Roche the first company with a test that can
aid in the diagnosis of CHF and provide prognosis for CHF and acute
coronary syndrome (ACS). These validated uses for risk stratification
in CHF and ACS patients, will provide physicians additional tools
to combat the ongoing cardiac disease epidemic.
"This clearance marks some tremendous strides in the detection
of heart disease and with more than 500,000 new cases of congestive
heart failure annually, it is critical that the medical community
has access to these types of tests," said Martin Madaus, President
and CEO, Roche Diagnostics. "The prognoses for CHF and ACS
are further evidence of Roche Diagnostics' commitment to improved
cardiac care for patients and financial containment for the healthcare
system."
"NT-proBNP is a superb biomarker, adding critical information
regarding both diagnosis and prognosis, across a wide range of cardiovascular
syndromes. NT-proBNP is not just a diagnostic marker for congestive
heart failure (though it is outstanding for this use)--it also adds
unique prognostic information for patients with ischemic heart disease
as well. The FDA clearance for risk stratification use in acute
ischemic syndromes only confirms the value of this marker. I believe
that every patient with suspected CHF or suspected acute coronary
ischemia should have a NT-proBNP measured," said James L. Januzzi,
Jr, MD, FACC, Cardiology Division, Massachusetts General Hospital.
"In my view, the addition of NT-proBNP to the armamentarium
of the physician represents one of the biggest steps forward in
cardiac biomarker testing since the advent of the troponins, but
I believe that NT-proBNP promises to have an even more widely-reaching
impact than the troponins, given the wide range of clinical syndromes
that NT-proBNP use appears to have."
The Elecsys® proBNP immunoassay is approved for use on the
Roche Elecsys® 1010, Elecsys® 2010 and MODULAR ANALYTICS
E170 immunoassay analyzers.
Various studies in the United States and Europe have provided the
information and validation for these classifications.
About Roche and the Roche Diagnostics Division
Headquartered in Basel, Switzerland, Roche is one of the world's
leading innovation-driven healthcare groups. Its core businesses
are pharmaceuticals and diagnostics. Roche is number one in the
global diagnostics market, the leading supplier of pharmaceuticals
for cancer and a leader in virology and transplantation. As a supplier
of products and services for the 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 employs roughly
65,000 people in 150 countries. The Group has alliances and research
and development agreements with numerous partners, including majority
ownership interests in Genentech and Chugai. 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 world-wide. Roche Diagnostics' North American headquarters
is located in Indianapolis, Ind. (www.roche-diagnostics.us).
For further information, please visit our websites www.roche.com
and www.roche-diagnostics.com.
For additional information contact:
Lori LeRoy
Roche Diagnostics
Tel.: +1-317-521-7159
e-mail: lori.leroy@roche.com
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