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FDA: New Test Estimates Risk of Cardiovascular Disease

Last Updated: December 15, 2014.

A new screening test designed to estimate a person's risk of developing coronary heart disease has been approved by the U.S. Food and Drug Administration.

MONDAY, Dec. 15, 2014 (HealthDay News) -- A new screening test designed to estimate a person's risk of developing coronary heart disease (CHD) has been approved by the U.S. Food and Drug Administration.

Results of a manufacturer study reviewed by the FDA indicate the test is better at discerning this risk in women, notably black women, the agency said in a news release.

The PLAC Test for Lp-PLA2 Activity, intended for people without a prior history of cardiovascular disease, measures the activity of lipoprotein-associated phospholipase A2, a blood biomarker for vascular inflammation. Patients with test results that show Lp-PLA2 activity ≥225 nmol/min/mL are at increased risk for a CHD event, while those with test results below this level are at decreased risk.

"A cardiac test that helps better predict future CHD risk in women, and especially black women, may help health care professionals identify these patients before they experience a serious CHD 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 the news release. "We hope the clearance of this test will improve preventative care and reduce CHD-related mortality and morbidity in these patients."

The new test is produced by diaDexus Inc., based in San Francisco.

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