FDA Approves New Blood Test to Predict Heart Disease Risk

US Food and Drug Administration (FDA) has approved a new blood test that can determine risk of coronary heart disease (CHD).

According to UPI, the new test identifies the biomarker Lp-PLA2 which indicates inflammation of arteries due to clogging by plaques. A count greater than 225 nanomoles is associated with a 7 % risk of CHD. Anything below the cut off indicates reduced risk. The test is better suited for women, African-American women in particular.

"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," said Alberto Gutierrez from the FDA's Center for Devices and Radiological Health, in a news release.

Before FDA could recommend the blood test it was put through a trial involving 4,598 people aged between 45 and 92 years and with no history of CHD. During the trial, the study subjects were followed for 5.3 years.

"The FDA requested data analyses of additional subgroups, including black women, which showed that black women experienced a higher jump in the rate of CHD events compared to other participants when Lp-PLA2levels were higher than 225 nmol/min/mL," FDA said in the release.

Heart disease is the leading cause of sudden death in US claiming 385,000 every year. Nearly two-thirds are women while the rest are men. Currently risk of CHD is predicted through bad cholesterol levels in the blood, an indicator not reliable.