The Food and Drug Administration (FDA) has recently approved a blood test that can detect pregnant women who are at high risk of developing pre-eclampsia, a severe form of high blood pressure that poses a significant threat to both the mother and the baby. Pre-eclampsia is a leading cause of disability and death among pregnant women, and it disproportionately affects Black women in the United States.
The new test, developed by Thermo Fisher Scientific, has been available in Europe for several years and has now received approval in the US. It is intended for pregnant women who are hospitalized for a blood pressure disorder between the 23rd and 35th weeks of gestation. The test can accurately determine, with up to 96 percent accuracy, which women will not develop pre-eclampsia within the next two weeks and can be safely discharged from the hospital. On the other hand, two-thirds of women who test positive will progress to severe pre-eclampsia within that time frame, and their babies may need to be delivered prematurely.
Pre-eclampsia affects approximately one in 25 pregnancies and has been on the rise in recent years in the US. It usually starts around the halfway mark of pregnancy but can also occur after childbirth. Pre-eclampsia can lead to eclampsia, a condition characterized by seizures and potentially fatal outcomes. Black women in the US have significantly higher rates of pre-eclampsia compared to white women and are three times more likely to suffer kidney damage or death from the condition. They also face a higher risk of losing their babies.
The blood test measures the ratio of two proteins produced by the placenta. A study published in NEJM Evidence found that women with severe pre-eclampsia had significantly imbalanced ratios of these proteins. Those with the widest ratios had a 65 percent chance of progressing to severe pre-eclampsia and delivering their baby within two weeks.
While this new blood test is a significant advancement in the diagnosis of pre-eclampsia, it is important to note that there is currently no effective treatment for the condition other than delivering the baby. The test provides an early warning system, enabling healthcare providers to closely monitor and manage high-risk pregnancies. However, further research is needed to determine how this test will impact outcomes and save lives.
Overall, the approval of this blood test marks a significant step forward in pre-eclampsia diagnostics, as it is the first major advancement in over a century. By identifying pregnant women at high risk of developing the condition, healthcare professionals can take necessary precautions and provide appropriate care, potentially improving outcomes for both mothers and babies.