Sera Prognostics, Inc., The Pregnancy Company™ focused on improving maternal and neonatal health through innovative precision biomarker approaches, today announced the publication of positive data in a large, independent, contemporary prospective U.S. clinical cohort study, TREETOP (NCT02787213), in the American Journal of Obstetrics & Gynecology Maternal Fetal Medicine.
The results of the study, which were selected for a podium presentation at the 40th Annual Pregnancy Meeting of the Society for Maternal-Fetal Medicine in February 2020, demonstrate that the company’s PreTRM® biomarker test can be used to predict very preterm birth, (infants born before 32 weeks of gestation) as well as increased length of neonatal hospital stay and severe adverse neonatal outcomes.
Preterm birth is the second leading cause of infant mortality – a national healthcare crisis affecting more than 1 out of 10 pregnancies annually, a number currently on the rise, and the leading cause of infant mortality and morbidity. Previously, healthcare professionals were not equipped to proactively identify the great majority of women who go on to deliver a baby prematurely. The study authors conclude that the PreTRM® test may serve as an important new tool for healthcare professionals and payers to identify at-risk women early in their pregnancies, enabling doctors to implement preterm birth preventive strategies and direct them to appropriate levels of care.
PreTRM is a serum-based proteomic test that uses the ratio of insulin-like growth factor-binding protein 4 (IBP4) to sex hormone-binding globulin (SHBG) to predict the risk of preterm birth. It is the only such clinically validated, commercially available blood test. The PreTRM® test provides an early and individual risk prediction for preterm birth in asymptomatic, singleton pregnancies.
“The number one complication of pregnancy is preterm birth,” says Dr. Glenn Markenson, director of maternal and fetal medicine at Boston Medical Center and an author on the publication. “Despite a keen awareness of the negative consequences of preterm birth, the inability to adequately predict the majority of women are, in fact, at greatest risk for preterm birth has been a significant barrier to broadly implementing preventive interventions. The TREETOP results support the potential of using the IBP4 to SHBG ratio to predict the risk of preterm birth and subsequent adverse neonatal outcomes. The ability to predict this risk is critical for enabling precision care management.”
TREETOP (The Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor) is the first study powered to investigate the performance of PreTRM® in predicting preterm births occurring before the 32nd week of gestation (<320/7) and investigating negative outcomes associated with these births, such as length of neonatal hospital stay and neonatal morbidity and mortality. The multi-center study enrolled 5,011 women across 18 sites nationally, with a preplanned analysis performed on a randomly selected subgroup of 847 women. Key findings from the sub-study include:
- Of infants born to these 847 women, 21 had evidence of severe neonatal condition, up to and including death
- The IBP4/SHBG ratio was significantly higher in both very preterm births <320/7 weeks and more severe neonatal outcomes
- The IBP4/SHBG ratio was significantly predictive of birth <320/7 weeks among all 847 women and when analyzed using a previously defined body mass index stratification (22 < BMI ≤37 kg/m2)
- The IBP4/SHBG ratio predicted neonatal outcomes for composite morbidity/mortality scores of ≥3 or 4
- The IBP4/SHBG ratio significantly identified women destined to deliver neonates with increased length of hospital stay
“Effective interventions that can delay or prevent preterm birth in a small fraction of patients carrying a single baby are well known within the maternal-fetal medicine community, but determining which additional women may benefit from these interventions requires validated prognostic tools,” said Gregory C. Critchfield, MD, MS, chairman and CEO of Sera Prognostics. “The TREETOP study results add to the growing body of data showing the clinical and scientific validity of Sera’s PreTRM® biomarker test as a comprehensive objective method for understanding each woman’s individual risk of preterm birth. Knowledge of a woman’s individual risk can make a difference because it empowers physicians and every expectant mother to work more closely together to address a woman’s risk for early delivery.”