FDA: New Test Estimates Risk of Cardiovascular Disease

Share this content:
FDA: New Test Estimates Risk of Cardiovascular Disease
FDA: New Test Estimates Risk of Cardiovascular Disease

(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.

More Information

Share this content:

is free, fast, and customized just for you!




Already a member?

Sign In Now »

Trending Activities

All Professions

Drug Lookup

Browse drugs by: BrandGenericDisease

More in Home

FDA Permits Marketing of Brain Stimulation Device for OCD

FDA Permits Marketing of Brain Stimulation Device for ...

FDA previously approved transcranial magnetic stimulation for major depression, certain migraines

Comments Open on End of NIH Review for Gene Therapy Studies

Comments Open on End of NIH Review for ...

NIH oversight panel no longer plans to review all applications for gene therapy experiments

U.S. Measles Outbreak Hits 107 Cases in 21 States, D.C.

U.S. Measles Outbreak Hits 107 Cases in 21 ...

Outbreak on track to exceed last year's; most of the people who got measles weren't vaccinated

is free, fast, and customized just for you!




Already a member?

Sign In Now »