Biosite plans further data as FDA panel rejects heart test
This article was originally published in Clinica
Executive Summary
Rapid test manufacturer Biosite Diagnostics has said it could file an amended PMA for US approval of its Triage BNP diagnostic for heart failure as early as late summer. The company's original application was rejected by an FDA advisory panel on March 24 by six votes to three after "major concerns" with the clinical data from US trials. The agency normally follows its panel's advice.