FDA approves bioMrieux heart failure diagnostic test

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The FDA has granted 510(k) clearance to bioMérieux, an in vitro diagnostics company, to market Vidas NT-proBNP, a test to diagnose heart failure.

Vidas NT-proBNP (N-terminal pro-B-type natriuretic peptide) is a quantitative marker of heart stress with the potential to detect all stages of heart failure, even the early stages, which can be difficult to detect, the l'Etoile, France-based company said.

The test provides diagnostic information that helps clinicians distinguish heart failure from other disease states with similar clinical symptoms, for instance lung diseases or pulmonary embolism, bioMérieux said.

NT-proBNP can also be used to assess the prognosis of patients with established heart failure or acute coronary syndrome, and its measurement is cost-effective and leads to important healthcare cost-savings as shown by analysis from a study at Brigham and Women's Hospital in Boston and a pivotal randomized multi-center study in Canada, the company reported.