FDA APPROVES BLOOD TEST THAT GAUGES HEART ATTACK RISK

By admin
January 13, 2015

(HealthDay News) – December 15, 2014, the Food and Drug Administration approved a new blood test that can help determine a person’s future odds for heart attack and other heart problems. According to the FDA the test is designed for people with no history of heart disease, and it appears to be especially useful for women.

“A cardiac test that helps better predict future coronary heart disease risk may help healthcare professionals identify these patients before they experience a serious event, like a heart attack,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.

The test, manufactured by San Francisco-based diaDexus, Inc., 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. As plaque accumulates, arteries narrow and the chances of a serious cardiovascular event increase.

The FDA’s approval of the new blood test comes from data compiled in a study funded by the 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.

The test seemed especially sensitive for African American 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.

The Centers for Disease Control and Prevention reports 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.

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