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FDA OKs Heart Failure Blood Test
Updated 6:49 PM ET November 21, 2000
Current quotes (delayed 20 mins.) BSTE 26.00 -1.75 (-6.31%)
By LAURAN NEERGAARD, AP Medical Writer
WASHINGTON (AP) - The government has approved a blood test to help doctors decide whether a patient who is short of breath is suffering from congestive heart failure.
Almost 5 million Americans have congestive heart failure. It's not a heart attack; instead, people's hearts gradually get flabby and lose the ability to pump blood because of age, damage from previous heart disease or some other disorder.
Particularly in early disease when symptoms are subtle, it can be hard to diagnose. Shortness of breath often is a first symptom, but that can signal numerous lung diseases as well as heart disease.
The new test, Biosite Diagnostics' Triage BNP, detects levels of a hormone called BNP, or B-type natriuretic peptide, that rises in the blood during heart failure, FDA medical officer Dr. Marva Moxey-Mims said Tuesday.
BNP is a hormone that helps guard the heart against excess salt and water retention, which occurs as the heart starts to fail. When the heart senses blood vessels constricting and salt and water levels rising, it releases BNP in an effort to protect itself, she explained.
The FDA based its approval on Biosite-funded studies of over 1,000 people in which the test helped doctors correctly diagnose between 76 percent and 98 percent of patients with congestive heart failure symptoms.
The test by itself can't diagnose heart failure - it's not perfect, the FDA cautioned. Women especially may get false readings. But a test that doesn't detect elevated BNP might signal doctors to check for lung disease instead of heart failure, while an elevated BNP might encourage an echocardiogram, Moxey-Mims said.
BNP testing is still evolving to see how useful it will be, cautioned American Heart Association spokeswoman Dr. Ann Bolger of the University of California, San Francisco.
But, "if it turns out to be as reliable as initially investigators feel, it will be helpful," she said. "It's a very targeted clue of how the body's responding" to heart failure.
San Diego-based Biosite said the test's first use probably will be in emergency rooms, where millions of people show up short of breath each year. The 15-minute test will cost about $30, the company said. |
