New blood test to predict preeclampsia receives FDA approval

Preeclampsia, or the rapid onset of high blood pressure in pregnancy, is one of the leading causes of maternal mortality—and it’s all too common. Occurring in about 1 in 25 pregnancies in the US, according to Centers for Disease Control and Prevention (CDC), the condition can often arise without symptoms, making it difficult to predict or detect—until it happens. But the Food and Drug Administration (FDA) recently approved a blood test that may serve as an early warning for preeclampsia, signaling that women who test positive may go on to develop the condition within two weeks.

The test from Thermo Fisher Scientific is designed to detect a specific imbalance of two placental proteins that can be used to predict whether a pregnant person might be at risk of developing a severe form of the condition. The test has been available in Europe for several years, The New York Times reports. 

“Doctors can use this in conjunction with other clinically available tests to stratify their patients to determine whether they’re at high risk for severe preeclampsia and complications, or at low risk, to be managed appropriately,” said Sarosh Rana, MD, MPH, chief of maternal-fetal medicine at the University of Chicago Medicine, and a key author of the study submitted to the FDA for approval, in a statement.

Preeclampsia can occur after week 20 in pregnancy and can set in even up to 6 weeks postpartum, and can be serious or life-threatening for both a mother and the developing baby, overburdening maternal organs and impacting blood flow to the placenta. Authorities suspect that the condition may have led to the recent death of Olympian Tori Bowie, who was 8 months pregnant. The condition disproportionately affects Black women, likely due to racism and systemic inequities that increase the risk of illness.

Annually, preeclampsia is responsible for over 70,000 maternal deaths and 500,000 fetal deaths worldwide, states the FDA. Until now, there’s been a dearth of clinical tools available to test for this condition since it was first identified in 1900. 

Symptoms of preeclampsia can be mistaken for common pregnancy symptoms

Hallmark symptoms, when they do appear, include persistent headaches, swelling, high blood pressure, changes in vision and signs of liver and kidney damage, such as protein in the urine, nausea or vomiting, and increased liver enzymes. Some, like headaches, swelling and nausea, are common in pregnancy. But developing preeclampsia in pregnancy can lead to long-term conditions later in life.

“Women who have preeclampsia are at higher risk for short-term and long-term hypertensive disorders and cardiovascular disease for the remainder of their lives.”

Sarosh Rana, MD, MPH

At 28 weeks, Jodi Klaristenfeld’s “seemingly ‘perfect pregnancy’” took a major turn. “I gained twenty pounds in five days, my urine turned orange, I started seeing spots, and my vision blurred,” she tells Motherly. “I later learned that I had a life-threatening condition called HELLP syndrome—a rare form of preeclampsia that eventually led to the preterm birth of my daughter.”

Klaristenfeld was induced hours after arriving at the hospital, and during delivery, her blood pressure rose to 190/150. Doctors gave her a platelet transfusion. “Had it not been for my mother’s encouragement to seek medical help, I’m not sure where I would be today. Fortunately, my daughter Jenna was born and, four years later, she is a happy and thriving little girl.”

Now an advocate for NICU parents and the founder of FLRRiSH, Klaristenfled is dedicated to spreading awareness about preeclampsia and preterm birth to help educate and empower families.

Identifying the need for increased monitoring

Outside of using medications to lower blood pressure, the only current treatment for preeclampsia is delivery. But the new test can help identify who may need increased care or monitoring or an induction to deliver early. If untreated, preeclampsia can progress to eclampsia, which can result in seizures and is a medical emergency.

Of those who get a negative test result, the blood test is 96% accurate that a patient will not develop preeclampsia in the next two weeks. Of those who get a positive test result, around 66% of those patients are expected to develop severe preeclampsia within two weeks and may need increased monitoring and possibly an early delivery. 

Experts and advocates have celebrated the test’s approval. “Patients and providers will benefit from having better tests to predict progression to preeclampsia with severe features, especially for those patients at risk of severe, early-onset disease or for whom there is some diagnostic uncertainty,” said Eleni Tsigas, CEO at the Preeclampsia Foundation, in a statement. “Our organization celebrates this result after many years of advocacy with leaders in research and regulatory bodies, such as the FDA, to accelerate the development and adoption of better clinical tools.” 

For decades, preeclampsia hasn’t been well understood, but now, researchers are making progress. Scientists at University of Virginia recently identified a specific “lipid signature” in women who develop preeclampsia that may also be used as a biomarker tool to spot the condition before it becomes severe. Researchers at Comanche Biopharma, led by Chief Medical Officer Allison August, MD, who worked on the Phase 3 clinical trial for Moderna’s mRNA Covid vaccine, are also working to develop a novel siRNA therapy for the treatment of preeclampsia.