Positive Clinical Validation Data for PreTRM® Test Presented at the Society for Maternal-Fetal Medicine’s 36th Annual Pregnancy Meeting
SALT LAKE CITY, February 4, 2016 – Sera Prognostics, Inc., a women’s healthcare company, today announced that results from the 5,501-patient Proteomic Assessment of Preterm Risk (PAPR) study validate the newly available PreTRM® test, which accurately and objectively predicts spontaneous preterm birth (sPTB), in pregnant women whose blood is drawn for analysis as early as 19 weeks of pregnancy. The data were presented at the Society for Maternal-Fetal Medicine’s 36th Annual Pregnancy Meeting in Atlanta, Georgia.
“The classifier performance of the proteins in the PAPR study was excellent,” said George R. Saade, M.D., Professor of Obstetrics and Gynecology at the University of Texas Medical Branch in Galveston and lead investigator. “The study found that this dual-protein biomarker test was highly predictive of preterm birth with statistically significant results early in pregnancy. These data demonstrate the powerful role proteomics can play in giving physicians a new tool to predict early an individual woman’s risk of spontaneous preterm birth.”
The 11-site PAPR study enrolled 5,501 pregnant women representative of the United States population. By taking a novel proteomic approach, this study validated a signature based on two proteins that are highly predictive of preterm birth risk: IBP4, insulin-like growth factor binding protein 4, and SHBG, sex-hormone binding globulin. The outstanding performance of the proprietary classifier using these proteins was independently validated.
“We express our thanks to the dedicated investigators and patients who participated in the PAPR study,” said Gregory C. Critchfield, M.D. M.S., Chairman and CEO of Sera Prognostics. “The PreTRM test assesses the risks of women earlier in pregnancy and helps physicians to make more proactive decisions in the care of mothers and babies. Sera’s work will serve as a foundation for future studies in developing better ways to improve maternal and fetal health.”
Other studies presented at the Society for Maternal-Fetal Medicine meeting included:
- “Verification of a proteomic serum-based classifier to predict spontaneous preterm birth in asymptomatic patients,” led by Kim Boggess, M.D., University of North Carolina, Department of Obstetrics and Gynecology, Professor, Division of Maternal Fetal Medicine. This study analyzed 148 sPTB candidate biomarkers in 312 subjects and verified IBP4 and SHBG as powerful classifiers predictive of sPTB.
- “Mechanistic insights from serum proteomic biomarkers predictive of spontaneous preterm birth,” led by Jeff Flick, Sr. Scientist, Sera Prognostics, Inc. This study analyzed blood samples from 312 women with gestational age ranging from 17-25 weeks. Researchers concluded that biomarker performance varies considerably across gestational age and may reflect impaired developmental transitions of the placenta and fetus during the second trimester.
The Society for Maternal-Fetal Medicine was established in 1977 to provide a forum for maternal-fetal medicine physicians and scientists to share knowledge, research methods and clinical best practices in order to improve the care of mothers and babies.
About Preterm Birth
According to the March of Dimes, globally preterm birth affects 15 million infants each year, with 1 million deaths occurring from prematurity. Of the 4 million babies born annually in the United States, more than one in nine is born prematurely. Preterm birth is defined as any birth before 37 weeks gestation, and is the leading cause of illness and death in newborns. Preterm birth is associated with a significantly increased risk of major long-term medical complications, including learning disabilities, cerebral palsy, chronic respiratory illness, intellectual disability, seizures, and vision and hearing loss. The complications from preterm birth can also extend beyond the first year of life, and can generate significant costs throughout the lives of affected children.
About the PreTRM® Test
The PreTRM test is a powerful blood test that provides an early and individual risk prediction for spontaneous preterm birth (sPTB) in asymptomatic, singleton pregnancies. The PreTRM test can help physicians identify early in the pregnancy (during weeks 19 and 20 of gestation) which women are at higher risk so that they can take action early with the goal of prolonging pregnancies and improving neonatal outcomes. Using proteomic technology, the PreTRM test measures and analyzes proteins in the blood that are predictive of preterm birth. Better understanding of the proteins expressed in pregnancy may lead to understanding the causes of preterm birth and making further advancements in prolonging gestational age and improving newborn outcomes.
For more information about the PreTRM® test, please visit www.PreTRM.com.
About Sera Prognostics, Inc.
Sera Prognostics is a private biotechnology company developing innovative diagnostic tests designed for the early prediction of preterm birth risk and other pregnancy complications. Sera’s tests are designed to help better inform the care of a mother and her unborn child during pregnancy, and potentially lead to improved health. The company has assembled a strong management team and Board of Directors with significant clinical development and women’s healthcare diagnostic experience. The Company is supported by a strong group of investors, including The Bill and Melinda Gates Foundation, Chione, Ltd, Domain Associates, InterWest Partners, Catalyst Health Ventures, UpStart Life Sciences Capital, and Osage University Partners. The Company is working with the Bill and Melinda Gates Foundation to translate its discoveries and develop technologies to benefit women and infants in underserved countries worldwide. Sera Prognostics is located in Salt Lake City, Utah. For more information, please visit the company’s website at www.seraprognostics.com.
Andrew Sauter, CFO
Sera Prognostics, Inc.
Media Contact for Sera Prognostics:
Continuum Health Communications