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FDA Approves Blood Test That Gauges Heart Attack Risk
The screen is meant for people without history of heart disease, agency saysMonday, December 15, 2014
MONDAY, Dec. 15, 2014 (HealthDay News) -- The U.S. Food and Drug Administration on Monday approved a new blood test that can help determine a person's future odds for heart attack and other heart troubles.
The test is designed for people with no history of heart disease, and it appears to be especially useful for women, and black women in particular, the agency said.
"A cardiac test that helps better predict future coronary heart disease risk in women, and especially black women, may help health care professionals identify these patients before they experience a serious [heart disease] event, like a heart attack," Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said in an agency news release.
The test tracks the activity of a specific biological signal of vascular inflammation, called Lp-PLA2. Vascular inflammation is strongly associated with the buildup of artery-clogging plaques in blood vessels, the FDA explained. As plaque accumulates, arteries narrow and the chances of a serious cardiovascular event increase.
"Patients with test results that show Lp-PLA2 activity greater than the level of 225 nanomoles per minute per milliliter are at increased risk for a [heart disease] event," the FDA said.
The FDA said its approval of the new blood test comes from data compiled in a study funded by the U.S. National Institutes of Health. Almost 4,600 people aged 45 to 92 with no prior history of heart disease took part in the study, and were followed for an average of just over five years.
In subgroup analyses, the test seemed especially sensitive for black women, because they experienced a "higher jump" in the rate of heart attack and other heart disease events when their blood levels of Lp-PLA2 exceeded a certain level.
"As a result, the test's labeling contains separate performance data for black women, black men, white women and white men," the FDA said.
The test is manufactured by San Francisco-based diaDexus, Inc.
According to the U.S. Centers for Disease Control and Prevention, heart disease remains the leading killer of Americans, and coronary heart disease is the most common form of the illness, killing over 385,000 people each year. "Almost two-thirds of women and half of men who die suddenly of coronary heart disease have no previous symptoms," the FDA noted.
SOURCE: Dec. 15, 2014, new release, U.S. Food and Drug Administration
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