The FDA approved a new indication for Roche Diagnostics' Elecsys proBNP test for the quantification of NT-proBNP (B-type natriuretic peptide) in serum plasma, allowing its use to assess the risk for cardiac events in patients with stable coronary artery disease. The test is available for use on the company's Elecsys systems and Modular Analytics E170 immunoassay analyzers.
The assay is the first natriuretic peptide test to be approved for this indication. Previously, the assay was approved as an aid in the diagnosis of congestive heart failure (CHF) and as a marker of risk for patients with acute coronary syndrome and CHF.
The fully automated assay provides rapid results (in as little as 18 minutes) using serum or plasma samples and is compatible with routine laboratory testing. The test helps to identify patients requiring further cardiac assessment, leading to more cost-effective use of echocardiography.