Research advances biological understanding of hypertensive disorders of pregnancy

Diagnostics company Mirvie has announced the results of a breakthrough study that reveals new advances in the biological understanding of hypertensive disorders of pregnancy (HDP), including preeclampsia – a leading cause of maternal morbidity and mortality as well as preterm birth.

Researchers used data from more than 9,000 pregnancies within the multi-centre Mirvie-sponsored Miracle of Life prospective study to discover and validate RNA signatures capable of distinguishing between severe and mild hypertensive disorders of pregnancy, including preeclampsia, months before symptoms occur.

The paper also validates the predictive performance of Mirvie’s simple blood test to predict risk of preeclampsia early, at 17.5 to 22 weeks gestational age, in pregnancies without any pre-existing high-risk conditions.

“By the time a patient is symptomatic, it’s a race against the clock to try to get the baby to term and not risk the mother’s health,” said Dr. Kara Rood, a maternal-foetal medicine physician, one of the principal investigators of the study, and Clinical associate professor of Obstetrics and Gynaecology at The Ohio State University Wexner Medical Center.

“Current guidelines are not helping us identify which patients are truly at high risk and we need better tools. Mirvie’s preeclampsia risk prediction test can now improve risk assessment, helping women and their care teams be informed and take actions with the potential to delay onset or prevent the disease.”

Despite current guidelines from US Preventive Services Taskforce and the American College of Obstetrics and Gynaecology that use general maternal characteristics to identify pregnant women at increased risk for preeclampsia, rates of the disease have nearly doubled in the last decade and now affect one in 12 pregnancies.

Mirvie’s blood test uses RNA signatures to resolve this ambiguity, helping pregnant women and their providers focus on the one in four pregnancies that are truly at high risk, ensuring optimal care for the right patients.

The results of this study demonstrate that relying on molecular signals from the underlying biology is far more effective in determining whether risk for preeclampsia is high or low.

Validation results show the simple blood test can identify 91 per cent of pregnancies that will develop preterm preeclampsia in women aged over 35 without pre-existing high-risk conditions, months ahead of symptoms. Those with a low-risk result have 99.7 per cent probability of not developing preterm preeclampsia. The clinically validated blood test will soon be broadly available under the brand name Encompass.

“Over the last 100 years, we have relied on a reactive care model in pregnancy. This study represents a profound opportunity to move toward a proactive care model,” said Dr. Thomas McElrath, vice president of clinical development at Mirvie and a maternal-foetal medicine physician at Brigham and Women’s Hospital in Boston.

“Importantly, these results demonstrate for the first time the unique molecular signatures that distinguish between severe and mild hypertensive disorders of pregnancy, giving us confidence in a much more precise and personalised approach for at-risk pregnancies.”

Today, the adherence to known valuable interventions for pregnancies at high risk of preeclampsia such as daily aspirin is less than 50 per cent, even among high-risk patients. With a blood test available early in the second trimester, pregnant patients and care teams can intervene months before symptoms and more confidently implement an evidence-based prevention care plan to improve the chance for a full-term pregnancy and healthy delivery.

“We are thrilled with the results from our investments in this critical research and collaboration with more than a dozen internationally renowned experts in maternal-foetal medicine,” said Maneesh Jain, co-founder and CEO of Mirvie.

“Much like the discovery of molecular subtypes of breast cancer led to improved outcomes, the discovery of molecular subtypes in HDP offers a bright future for personalising pregnancy care and addressing the rising rates of births with complications.”

The novel findings add to the growing body of research demonstrating the use of the Mirvie RNA platform to predict pregnancy complications months in advance, including studies on preeclampsia risk prediction and preterm birth risk prediction, and research presented in January at the Society for Maternal-Foetal Medicine conference on prediction of fetal growth restriction.