The NT-proBNP test from Roche Diagnostics was recently cleared by the Federal Food and Drug Administration (FDA) for risk stratification in congestive heart failure (CHF) and acute coronary syndrome (ACS). According to Martin Madaus, president and CEO of Roche Diagnostics, this clearance makes Roche the first company with a test that can aid in the diagnosis of CHF and provide prognosis for CHF and ACS. These validated uses for risk stratification in CHF and ACS patients will provide physicians additional tools to combat the ongoing cardiac disease epidemic. Roche’s Elecsys® proBNP immunoassay for detecting the level of the NT-proBNP peptide as an aid in the diagnosis of CHF received FDA clearance in November 2002.

“This clearance marks 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,” says Madaus.

“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; 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 NT-proBNP measured,” says James L. Januzzi, Jr, MD, FACC, Cardiology Division, Massachusetts General Hospital.