The November publication of a study* in Circulation, the journal of the American Heart Association, has patients excited about a new test developed by Alere, Inc. that uses a unique placental protein to determine if a woman has, or will develop, preterm preeclampsia. The test, which measures the maternal blood level of Placenta Growth Factor, or PlGF, is currently available for clinical use in Europe, Australia, China, and India. Although Alere is in communication with the United States Food and Drug Administration (FDA), the necessary clinical trials have not yet been completed for its introduction in the United States.
Why the test was developed and reported results:
"The test is designed to differentiate women with preeclampsia from those with high blood pressure alone," said Lucy Chappell, Ph.D., clinical senior lecturer in Obstetrics at King's College in London. "Current tests for the condition only detect that it's happening, rather than predicting it, and by that time the disease has progressed and has likely already caused organ damage. The test identifies women at high risk for developing preeclampsia, so doctors can better monitor and treat the blood pressure. It also prevents unnecessary hospitalizations of those who are not likely to develop preeclampsia."
Included in the study were 625 patients from various centers in the United Kingdom, who developed signs or symptoms of preeclampsia between 20 and 41 weeks' pregnancy. The published study focused on those 278 women who presented prior to 35 weeks gestation (average gestational age was 31 weeks), when the consequences of an incorrect diagnosis are most grave. Among the women with low levels of PlGF (* The study was funded by Tommy's Charity in London, England, and Alere, Inc. Tommy's Charity funds research on pregnancy complications, and provides information to expecting parents with the objective of improving maternal and fetal health. Alere is a multinational corporation of several leading diagnostic and health management companies with expertise in more than 100 disease categories offering products and services ranging from lab-based diagnostics to in-home monitoring solutions.
According to company material, the “Alere Triage® PlGF is an aid in the diagnosis of preterm pre-eclampsia and prognosis of preterm delivery in women presenting with suspected pre-eclampsia before 35 weeks.” Alere asserts that when PlGF is incorporated into the diagnostic work-up alongside current methods, the Alere Triage® PLGF test can help improve accuracy of diagnosis, reduce the need for additional testing, and ensure the right women are referred to tertiary care for delivery.”
Studies are needed to learn how the test alters healthcare practices, outcomes, and expenditures. For example, it is unknown whether introduction of the PLGF test will change the frequency and extent of prenatal evaluation, change the timing of delivery, or reduce adverse outcomes and medical costs.
“In the absence of compelling scientific evidence, a test such as this would not change how vigilantly we monitor and manage women with hypertension or other medical conditions or history that places their pregnancy in a higher risk category,” said Dr. Doug Woelkers, a preeclampsia researcher and Associate Clinical Professor in the Division of Perinatal Medicine at University of California, San Diego, who sees high-risk women at several hospitals and clinics in the area. “Because preeclampsia onset can occur very suddenly and rapidly progress, we are always re-evaluating our patients. This is not to say, however, that PlGF level might not one day play a role in our maternal-fetal management and delivery-timing decisions. We’re seeing lots of research on ‘the preeclampsia front’ that can eventually lead to beneficial discoveries. PlGF has been and is the focus of several studies. Controlled clinical trials will reveal more. In the meantime, it is my hope that my colleagues be alert for all the clinical signs and symptoms and educate all of their patients about these. All parties — healthcare providers, patients and their support people — need to be vigilant and realize that preeclampsia can ‘hit’ any pregnant woman and progress within hours.”
* The study was funded by Tommy’s Charity in London, England, and Alere, Inc. Tommy’s Charity funds research on pregnancy complications, and provides information to expecting parents with the objective of improving maternal and fetal health. Alere is a multinational corporation of several leading diagnostic and health management companies with expertise in more than 100 disease categories offering products and services ranging from lab-based diagnostics to in-home monitoring solutions.