• Posted May 15, 2024

New Blood Test Could Help Spot Preeclampsia in First Trimester

Preeclampsia can be a life-threatening complication of pregnancy, but a new blood test can help predict a woman's risk for the condition while she is in her first trimester, the test's maker said Wednesday.

It's the first test in the United States that can be used between 11 and 14 weeks gestation to determine the risk of preeclampsia before 34 weeks of pregnancy, Labcorp said in a news release announcing the launch of the test.

"By giving healthcare providers another tool to assess preeclampsia risk in their pregnant patients with objective biomarkers, we're helping to advance prenatal care and improve outcomes for mothers and their babies,"Labcorp's Chief Medical and Scientific Officer Dr. Brian Caveney said in the news release.

Roughly one in 25 U.S. pregnancies is affected by preeclampsia, which poses an even greater risk for Black women, who experience the condition at a 60% higher rate than white women do, the company noted.

Still, some doctors wonder how much it will help.

"It is currently unclear how useful the Labcorp test will be in accurately predicting risk for developing preeclampsia and whether it is appropriate for all pregnant patients,"Dr. Christopher Zahn, interim CEO at the American College of Obstetricians and Gynecologists (ACOG), told CNN.

"Before a screening test can be successfully employed, there needs to be an evidence-based intervention to either prevent or reduce the impact of the disease. We currently have no data on how to reduce the risk for a pregnant patient predicted to have preeclampsia from a blood test early in pregnancy as opposed to clinical factors,"Zahn added.

Another doctor echoed those concerns.

"The utility of the test in managing patients has yet to be proven and it is not clear that it helps more than it could possibly hurt. It is not clear that the use of this test is any better than the current standards for prenatal care,"Dr. Christian Pettker, chief of obstetrics at Yale-New Haven Hospital, told CNN.

"It is not clear to me that this is appropriate for all patients who are pregnant in the first trimester. Perhaps the most applicable group could be for patients who had preeclampsia in a prior pregnancy, though these patients already have a high risk and are often followed differently in their pregnancy,"Pettker added.

Preeclampsia is marked by elevated blood pressure, high levels of protein in the urine or other signs of organ damage. Typically, the condition surfaces after 20 weeks of pregnancy, according to the Cleveland Clinic.

There is no cure for preeclampsia, apart from delivering the baby, although severe cases can be managed with medications that include blood pressure drugs.

The new test measures the risk of preeclampsia with up to 90% sensitivity and 90% specificity, according to Labcorp. Sensitivity is the ability to identify pregnancies at high risk, while specificity refers to the opposite.

Labcorp is in talks with health insurers to see if the test could be covered, Caveney said, adding that it carries a list price of about $240. The test works by measuring four biomarkers associated with preeclampsia risk.

Eleni Tsigas, chief executive officer of the Preeclampsia Foundation, told CNN that such a test could have "significantly"changed her first pregnancy experience if it had existed in 1998.

Tsigas was diagnosed with preeclampsia just 11 weeks before her due date, and her daughter was stillborn following complications of the condition.

"My daughter died, and it was all due to a last-minute emergency,"she said.

But the new first-trimester screening test, "if it's done right, it has the potential to eliminate those surprise cases"of preeclampsia, Tsigas added.

"This has issues with payer coverage and education and making sure that all women, no matter their socioeconomic status, are aware that this kind of information should be available to everybody," she said. "If it is, it has the potential to reduce the [racial] disparities we're seeing in maternal health outcomes and neonatal health outcomes. Tests like this absolutely move the bar."

More information

The Preeclampsia Foundation has more on preeclampsia.

SOURCE: Labcorp, news release, May 15, 2024; CNN