FDA Approves New Blood Test That Predicts Risk of Heart Attack and Disease, Especially for Black Women
On Monday, the U.S. Food and Drug Administration approved a new blood test that makes it easier for doctors to detect if someone is at risk for a heart attack and heart disease.
The screening test, which is manufactured by diaDexus, Inc. in San Francisco, is designed for people with no history of heart disease, and it appears to be especially effective for black women, the agency said in a press release. It works by measuring the inflammation caused by the buildup of plaque in the arteries, which can be used to gauge a patient's risks of having a heart attack or stroke.
"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 via the release.
The test tracks the activity of a specific biological signal of vascular inflammation, called lipoprotein-associated phospholipase or Lp-PLA, in a patient's blood.
According to the FDA, vascular inflammation is linked to the buildup of artery-clogging plaques in blood vessels. If the plaque continues to accumulate, it can create a narrowing of the arteries and greatly increase the chances of a serious cardiovascular event as a result.
"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 also found that the test seemed particularly effective for African-American women because they experienced a "higher jump" in the rate of heart attack and heart disease when their blood levels of Lp-PLA2 surpasseda 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.
American Heart Association expert Dr. Jennifer Mieres of the North Shore-LIJ Health System said that the new test will be "much more readily available and reimbursable by insurers."
"When you put it in context with the fact that black women are at the highest risk of coronary disease ... this makes it really easier to target women at higher risk," she told NBC News.
The U.S. Centers for Disease Control and Prevention said that heart disease is the leading cause of death for Americans, while coronary heart disease is the most common form of the illness and kills more than 385,000 people a year.
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