Biosite files amended PMA (pre-market approval) for CHF (congestive heart failure) test:
This article was originally published in Clinica
Biosite Diagnostics has submitted to the US FDA an amendment to its PMA application for its Triage BNP test for congestive heart failure (CHF). The amendment contains data that was requested by an FDA advisory panel, which earlier this year turned down the company's original PMA. "We have submitted data using a control group whose ages closely match those of the population of CHF patients," said the San Diego, California, company. "We have provided more data relevant to female CHF patients and to patients in certain ethnic groups," it added. The test measures B-type natriuretic peptide in whole blood and plasma.