Biosite Diagnostics
This article was originally published in The Gray Sheet
Executive Summary
San Diego-based firm files an amendment to its pre-market approval application for the Triage B-Type Natriuretic Peptide (BNP) congestive heart failure point-of-care test. FDA's Clinical Chemistry and Clinical Toxicology Devices Panel requested that the firm submit additional data pointing to the test's efficacy in at-risk populations. In March, the panel voted 6-3 against recommending approval of the test (1"The Gray Sheet" March 27, 2000, p. 7)