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Biosite finally wins approval for heart failure test

This article was originally published in Clinica

Executive Summary

Biosite Diagnostics has at last been granted approval by the FDA to market its Triage BNP Test in the US as an aid in the diagnosis of congestive heart failure (CHF) in patients aged 55 and over. The San Diego, California company's original PMA application for the test was rejected by an FDA advisory panel last March and an amended application was submitted barely two months ago (see Clinica No 929, p 21).

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