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Biosite Should Enroll Elderly With Concomitant Illness In CHF Studies - Panel

This article was originally published in The Gray Sheet

Executive Summary

Biosite Diagnostics should enroll elderly people who may have various types of coronary disease or renal insufficiency in order to validate claims that the Triage B-Type Natriuretic Peptide (BNP) point-of-care test effectively diagnoses congestive heart failure (CHF) in at-risk populations, FDA's Clinical Chemistry and Clinical Toxicology Devices Panel recommended March 24 in Rockville, Maryland.

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Biosite Triage BNP Heart Failure Blood Test Has 84.4% Sensitivity

Biosite Diagnostics' Triage B-Type Natriuretic Peptide (BNP) point-of-care test shows a sensitivity of 84.4% and a specificity of 95.6%, according to data supporting the firm's premarket approval application.

Biosite Triage BNP Heart Failure Blood Test Has 84.4% Sensitivity

Biosite Diagnostics' Triage B-Type Natriuretic Peptide (BNP) point-of-care test shows a sensitivity of 84.4% and a specificity of 95.6%, according to data supporting the firm's premarket approval application.

Biosite Diagnostics

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)

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