The Food and Drug Administration (FDA) gave its blessing to two new screening tests: one can predict a heart attack, especially in women, and one can spot a potentially fatal newborn disease.
The FDA has just approved a new test that predicts a person’s risk of coronary heart disease (CHD) events, such as a heart attack or stroke.
The test was approved for use in all adults with no history of heart disease, but data suggest the test is particularly good at predicting the risk of CHD events in women, especially black women.
Dr. Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA, said in a statement, “A cardiac test that helps better predict future CHD risk in women, and especially black women, may help healthcare professionals identify these patients before they experience a serious CHD event, like a heart attack.” He also said the agency hopes the test will improve preventive care and reduce heart disease-related illnesses and deaths.
According to the Centers for Disease Control and Prevention (CDC), heart disease is the most common cause of death in the United States among people of most racial and ethnic groups. About 385,000 people die each year from CHD, the most common kind of heart disease.
The new test is called the PLAC Test for Lp-PLA2 Activity. It measures the amount of an enzyme called lipoprotein-associated phospholipase A2 (Lp-PLA2) in a patient’s blood. Higher levels of this enzyme are associated with inflammation. This inflammation can lead to the buildup of plaque that can clog arteries and cause CHD. People with Lp-PLA2 levels higher than 225 nanomoles per minute per milliliter (nmol/min/mL) are at higher risk for CHD events.
To see if the PLAC Test could accurately predict CHD risk, researchers used it to test the blood of nearly 4,600 people who had never had CHD. They followed these people for an average of five years and recorded any CHD-related events.
The researchers found that people with Lp-PLA2 levels above 225 nmol/min/mL had a 7 percent chance of a CHD event, and those with an Lp-PLA2 level below 225 nmol/min/mL had about a 3 percent chance.
The FDA asked the researchers to analyze data from particular subgroups of people. They found that compared to other demographic groups, black women had more CHD events when their Lp-PLA2 levels were higher than 225 nmol/min/mL. The labeling information on the test contains separate data for white men, white women, black men, and black women.
Commenting on the FDA’s approval of the PLAC test, Dr. Robert Rosenson, a cardiologist at The Mount Sinai Hospital in New York City, told Healthline, “Lp-PLA2 activity has been shown to be a consistent marker of CHD risk in patients with stable CHD and within the general population.”
However, Rosenson also said it’s unclear how the results of this test would change what doctors already do for patients with CHD or who are at risk for CHD.
The FDA also approved the EnLite Neonatal TREC kit, the first test for Severe Combined Immunodeficiency (SCID) in newborns.
According to the CDC, 40 to100 new cases of SCID are identified in newborns in the United States each year. SCID is a group of disorders caused by defects in genes involved in the development of T cells and other infection-fighting immune cells.
Babies with SCID appear normal at birth, but typically develop life-threatening infections within a few months. Without early intervention, death can occur within the baby’s first year. Early detection and treatment can markedly improve survival.
The EnLite Kit uses a few drops of blood from a baby’s heel to test for a type of DNA called T-receptor excision circles (TREC). Babies with SCID usually have low levels of TREC or no TREC in their blood, compared to healthy babies.
The FDA reviewed data from about 6,400 babies before giving its approval. Seventeen babies had a confirmed diagnosis of SCID. The EnLite Kit correctly identified all of them.
Commenting on the FDA’s approval of the EnLite kit, Gutierrez said in a press statement that for the first time, states can include an FDA-reviewed test for SCID in their routine testing of newborns.
The Secretary of the U.S. Department of Health and Human Services, as well as the Advisory Committee on Heritable Disorders in Newborns and Children, recommend that every state screen newborn babies for SCID. Currently, 25 states, the District of Columbia, and the Navajo Nation have SCID screening programs in place.