FDA Approves New Blood Test For Heart Disease Risk

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The FDA has issued approval on a new blood test that can help predict heart disease risk. The new test, called PLAC Test for Lp-PLA2, has been approved for use in both men and women who have no previous history of heart disease.

The new test uses blood analysis to look for Lp-PLA2 (lipoprotein-associated phospholipase A2), an enzyme that is indicative of pulmonary inflammation. Patients with the enzyme at levels over 225 nanomoles per minute per milliliter (nmol/min/mL) in their blood are at a particularly high risk for heart disease and this new test can give a specific view of Lp-PLA2 levels.

Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, says, "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. We hope the clearance of this test will improve preventative care and reduce CHD-related mortality and morbidity in these patients."

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