According to new data, Mirvie’s RNA platform can predict which unborn babies have severe growth restriction—a leading cause of stillbirth—far more accurately than current methods. Further, they found that severe growth restriction has a unique RNA signature independent of other factors that can impact fetal growth. Severe growth restriction.
The company’s findings were announced at the Society for Maternal-Fetal Medicine annual meeting today. The presenter was Kara Rood, a maternal-fetal medicine specialist and clinical associate professor of obstetrics and gynecology at The Ohio State University Wexner Medical Center and principal investigator of the study.
Mirvie has already used its RNA platform to predict preeclampsia risk, published in Nature and preterm birth risk prediction published in the American Journal of Obstetrics and Gynecology.
“There’s a large unmet need to better identify babies most at risk for stillbirth and other negative outcomes as indicated by poor growth because the majority are undiagnosed before birth,” said Rood. “Approximately 70% of babies with severe growth restriction— characterized as babies in the third percentile for growth and at highest risk for stillbirth— are missed by a standard ultrasound.”
Drawing upon what they describe as “the largest molecular study of pregnancy completed to date.” From this database, for this study they examined more than 5,000 geographically and demographically diverse pregnancies. Analyzing millions of maternal, fetal, and placental RNA messages using the Mirvie RNA platform. Key findings include:
- They predicted 60% of babies with severe fetal growth restriction months in advance of delivery, a significant improvement over the current standard of care.
- Current clinical risk factors used today, like advanced maternal age, maternal height, smoking status, and obesity are not predictive.
- The Mirvie RNA Platform found severe growth restriction has a unique RNA signature independent of preeclampsia, chronic hypertension, and gestational diabetes, all of which can impact fetal growth.
“Similar to the breakthroughs that propelled the molecular understanding of breast cancer in the 1990s, obstetrics can now move towards a new standard of care based on the molecular characteristics of each pregnancy,” said Maneesh Jain, CEO and co-founder of Mirvie. “With the Mirvie RNA Platform, we can move toward a proactive and personalized care approach in maternal health that focuses on preventing serious pregnancy complications.”
“At a molecular level, we now understand how biology impacts which pregnancies are at highest risk for poor outcomes,” said Thomas McElrath, MD, PhD, vice president of clinical development at Mirvie and a practicing maternal-fetal medicine physician at Brigham Women’s Hospital.
He added, “This breakthrough removes the bias and variability associated with clinical risk factors and assessments currently used to determine which babies may be at highest risk for fetal growth restriction. With a worsening maternal health crisis, we need innovative tools like Mirvie’s RNA platform to change the status quo and create better outcomes for mothers and babies.”
For its platform, Mirvie has examined the biology of nearly 11,000 diverse pregnancies across the United States, collecting more than 20,000 RNA transcripts per patient and translating into 200 million data points overall.
