FDA Approves First Blood Test to Predict Preeclampsia in Pregnant Women

Pregnancy is a miraculous journey, but it can be fraught with uncertainties and complications, one of which is preeclampsia. Preeclampsia is a potentially life-threatening condition characterized by the sudden onset of high blood pressure in previously normotensive pregnant individuals. Recent developments in medical technology have led to the FDA’s approval of a groundbreaking blood test designed to predict preeclampsia. This diagnostic breakthrough promises not only to enhance maternal care but also to address healthcare disparities faced by women of color during pregnancy.

Understanding Preeclampsia: A Hidden Threat

Preeclampsia is a menacing disorder that can emerge unexpectedly during pregnancy, putting both the mother and baby at risk. According to the Centers for Disease Control and Prevention (CDC), preeclampsia affects approximately 1 in every 25 pregnancies in the United States annually. This condition, characterized by elevated blood pressure, typically presents after the 20th week of gestation but can also occur postpartum.

The severity of preeclampsia varies along a spectrum, with potential complications including seizures (eclampsia), pre-term birth, and adverse outcomes for both mother and child. Timely diagnosis and intervention are crucial for mitigating the risks associated with severe forms of preeclampsia.

A Diagnostic Revolution: The Preeclampsia Predictive Blood Test

A remarkable breakthrough in maternal care comes in the form of a blood test, developed by Thermo Fisher Scientific, which has recently received FDA approval. This innovative biomarker test boasts an impressive accuracy rate of 94%, predicting the development of severe preeclampsia within the next two weeks. Notably, the test has been in use in Europe for nearly a decade and has now been introduced to healthcare facilities in the United States.

The significance of this test lies in its ability to identify individuals who are at the highest risk of developing severe preeclampsia, facilitating early intervention and personalized care. Dr. Anum Minhas, an assistant professor of medicine specializing in cardio-obstetrics and cardiovascular disease in women at Johns Hopkins Medicine, explains that the test is intended for individuals who have already been diagnosed with preeclampsia or are exhibiting symptoms of the condition.

“The purpose is to predict who will have severe preeclampsia,” Dr. Minhas emphasizes. For these individuals, early hospitalization and monitoring may be necessary to safeguard both maternal and fetal well-being.

Unveiling the Power of Early Detection

The predictive blood test combines two biomarkers, placental growth factor (PlGF) and sFlt-1, to assess placental health. These biomarkers provide valuable insights within just 30 minutes of processing in a hospital’s diagnostics laboratory. This early detection can play a pivotal role in preventing the progression of preeclampsia to its severe forms.

High-risk individuals, typically advised to take low-dose aspirin daily during pregnancy, can now benefit from the additional information provided by the predictive test. The American College of Obstetricians and Gynecology (ACOG) recommends that high-risk mothers begin aspirin therapy before 16 weeks of gestation and continue until delivery. However, it’s important to note that the predictive test is currently approved for use in pregnant individuals between 23 and 34 weeks of gestation, potentially leaving out certain cases.

Tina Liedtky, president of clinical diagnostics at Thermo Fisher Scientific, highlights that the biomarker test has been employed as early as the first trimester in Europe. Efforts are underway to expand its use throughout pregnancy for U.S. patients. While the predictive blood test represents a significant advancement in obstetrics medicine, healthcare providers should continue to consider other relevant factors when assessing maternal health.

A Holistic Approach to Maternal Care

Doctors and healthcare providers emphasize that the predictive blood test should not be viewed in isolation but as part of a comprehensive approach to maternal care. Factors such as blood pressure levels and comorbidities must also be taken into account to make informed decisions about patient management.

Dr. Curtis Cook, medical director of maternal fetal medicine at Dignity Health Medical Group in Chandler, Arizona, underscores the importance of efficiency in healthcare delivery. He notes that the test can enhance the precision of determining which patients require additional testing or continuous hospitalization, optimizing resource allocation.

However, as Dr. Cook emphasizes, “It doesn’t replace a thorough examination and laboratory and ultrasound evaluations for patients with preeclampsia.” The test complements the existing diagnostic arsenal, contributing to more informed decision-making in maternal care.

Addressing Maternal Mortality and Healthcare Disparities

Preeclampsia is a condition that can affect anyone, but certain risk factors can elevate the likelihood of its occurrence. Women who have previously experienced preeclampsia in one pregnancy face a sevenfold increased risk of developing the condition in subsequent pregnancies. Other risk factors include obesity, advanced maternal age, and the expectation of multiple births (e.g., twins or triplets). Additionally, pre-existing medical conditions, such as migraines, diabetes, and autoimmune disorders, can further elevate the risk.

It’s crucial to recognize that preeclampsia can strike without warning, and its consequences can be devastating. A tragic example is the recent death of Olympic runner Tori Bowie, who was eight months pregnant when she and her unborn child tragically passed away due to complications related to preeclampsia.

Racial disparities in maternal care add another layer of complexity to the fight against preeclampsia. The FDA approval process for Thermo Fisher’s biomarker test included a diverse cohort of over 1,000 pregnant individuals, with 31% of participants being Black women. This is significant because Black women are 60% more likely to develop preeclampsia compared to individuals of other racial backgrounds.

Alarmingly, maternal mortality rates in the United States reveal stark racial disparities, with Black mothers being 2.6 times more likely to die in pregnancy than their White counterparts, as indicated by CDC data from 2021. The utilization of novel diagnostic tools, however, must be accompanied by efforts to address systemic issues within the healthcare system that contribute to healthcare inequities.

Towards Equitable Maternal Care

To ensure equitable access to new diagnostic tools, systemic barriers that hinder access to prenatal care, particularly during the first trimester, must be dismantled. Initiatives aimed at reducing healthcare disparities and improving the quality of care for individuals of color are imperative.

“This disease doesn’t discriminate based on race, but our health system sometimes does,” stresses Tina Liedtky. Objective measures provided by tests like the predictive blood test can be instrumental in saving lives and addressing healthcare disparities. However, they must be part of a broader commitment to equitable maternal care.

In conclusion, the FDA’s approval of the blood test for predicting preeclampsia marks a significant advancement in maternal care. This test, when used in conjunction with other diagnostic methods and a holistic approach to maternal health, has the potential to enhance outcomes for pregnant individuals while also contributing to the dismantling of healthcare disparities that disproportionately affect women of color during pregnancy.