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.

The panel voted 6-3 against recommending approval of the test for the intended indication for diagnosis of CHF, as an aid in the diagnosis and management of CHF, and as a point-of-care test to aid in the diagnosis and management of CHF in a laboratory or emergency room setting.

Panel members felt that data presented by the company pointed to efficacy in not-at-risk populations only.

"We don't know if this has any utility for mild CHF," noted panel member Philip Comp, MD/PhD, University of Oklahoma Health Sciences Center, said in expressing the sentiment of the panel. "We are stripped down to a test that measures the level of a peptide in the blood."

"The problem here is that safety and effectiveness has not been proven," panel member James Everett, MD/PhD, Madison Hospital, Madison, Florida, agreed. "There is safety and effectiveness in the best case only in young people."

Biosite claimed that comparisons of 585 "normal" and hypertensive patients against 408 CHF patients showed the test to have a mean 92.8% sensitivity and a mean specificity of 89.3%.

However, FDA's analysis pointed to age disparities in the two cohorts, with "healthy" patients having a mean age of 36 and CHF patients a mean age of 67. Panel members were worried that sensitivity and specificity estimates were overstated and that high detection of BNP levels were more a result of normal increase of the peptide with age than presence of CHF.

While Biosite argued that the test currently is a standard-of-care in Europe and that a wealth of literature supports these claims, panel Chairman Martin Kroll, MD, VA Medical Center, Dallas, countered that "there have been no studies shown to link this current method to the other methods that are out there, especially those that are quoted in the literature."

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

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