Congestive Heart Failure

FDA Advisory Panel Votes Triage BNP Test Not Approvable

Published in Medical Letter on the CDC and FDA, April 11th, 2000

Biosite Diagnostics, Inc. (BSTE), San Diego, California, announced that the U.S. Food and Drug Administration's (FDA) Clinical Chemistry and Clinical Toxicology Device Panel has voted not to approve the company's pre-marketing approval submission for its Triage BNP Test.

The Triage BNP Test is designed to provide physicians with rapid, quantifiable measurements of B-type natriuretic protein (BNP), a protein marker for congestive heart failure (CHF). In voting, the Advisory Panel indicated that it did not accept the company's application of clinical trial data supporting the proposed product claim that the Triage BNP Test could be an aid for the diagnosis of CHF at the...

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Source: Medical Letter on the CDC and FDA (2000-04-11)

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