Diagnostics

U.S. FDA OKs two additional claims for congestive heart failure test

Published in Medical Letter on the CDC and FDA, January 9th, 2005

Dade Behring Holdings, Inc., (DADE) announced that its NT-proBNP (N-terminal pro brain natriuretic peptide) test has received FDA (U.S. Food and Drug Administration) clearance for two additional claims - assessment of heart failure severity in patients diagnosed with congestive heart failure, and risk stratification of patients with acute coronary syndrome and heart failure.

Earlier, clearance was received for the use of NT-proBNP in the diagnosis of individuals suspected of having congestive heart failure. The fully automated test is available for use on the Dimension instruments with Heterogeneous Immunoassay Module.

"The availability of the...

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Source: Medical Letter on the CDC and FDA (2005-01-09)

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