Sera Prognostics Announces Clinical Study Data Selected for Presentation at the Society for Maternal-Fetal Medicine’s 36th Annual Pregnancy Meeting
SALT LAKE CITY, January 7, 2016 — Sera Prognostics, Inc., a women’s healthcare company, today announced that findings from the 5,501 patient Proteomic Assessment of Preterm Risk (PAPR) study will be reported in an oral presentation during the Society for Maternal-Fetal Medicine’s (SMFM) 36th Annual Pregnancy Meeting™ in Atlanta, February 1-6, 2016.
The abstract data will be presented Thursday, February 4th at 3:15 PM Eastern Standard Time by George R. Saade, MD, Professor of Obstetrics and Gynecology at the University of Texas Medical Branch in Galveston. The presentation, Clinical Validation of a two- protein test for spontaneous preterm birth (sPTB) prediction in a large multicenter prospective study of asymptomatic women, will focus on the results of a rigorous blinded evaluation of Sera’s PreTRM® test. The PreTRM test is a novel proteomic biomarker blood test designed to provide an early, objective, and individualized assessment of a woman’s risk of preterm birth.
“We are very pleased and honored to have Dr. Saade present these data as a podium presentation at this most prestigious meeting in maternal-fetal medicine,” said Gregory C. Critchfield, MD, MS, Chairman and CEO of Sera Prognostics. “This study encompassed four years of research using proteomic technology to analyze hundreds of candidate proteins to identify the relationship of two key biomarkers that are highly predictive of spontaneous preterm birth. This is a milestone enabling the achievement of Sera’s goal to address the enormous societal and economic consequences of preterm birth. The value of predicting which women are at risk early in the pregnancy will help physicians be more proactive in managing patients, with the goal of prolonging pregnancies and improving neonatal outcomes. Important future research will be made possible by this work.”
Data on the proteomic biomarkers discovered, verified and validated as preterm predictors will be presented as well in other SMFM posters:
Poster Abstract # 193 Verification of a proteomic serum-based classifier to predict spontaneous preterm birth in asymptomatic patients
First Author: Kim Boggess, MD
Poster Session I: February 4th 10:30 AM -12:30 PM ET
Abstract # 253 Mechanistic insights from serum proteomic biomarkers predictive of spontaneous preterm birth
First Author: Jeff Flick, PhD
Poster Session I: February 4th 10:30 AM – 12:30 PM ET
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 U.S., 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. Sera has conducted the Proteomic Assessment of Preterm Risk (PAPR) study, one of the world’s largest and broadest clinical trials to validate the performance of the Company’s PreTRM test. PAPR enrolled 5,501 patients from 11 centers across the United States, representing the diversity of the intended use population for asymptomatic singleton pregnancies. The PreTRM test is available to healthcare providers and their patients throughout the U.S. 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