Sera Prognostics Completes Enrollment of Large Proteomic Assessment of Preterm Risk Clinical Study
Sera Prognostics Completes Enrollment of Large Proteomic Assessment of Preterm Risk Clinical Study Aug 2013
5,500-Patient Multicenter Study Population is Broadly Representative of Pregnant Women Across the U.S.
SALT LAKE CITY, Aug. 21, 2013 (GLOBE NEWSWIRE) -- Sera Prognostics, Inc., a women's healthcare company, today announced that it has completed enrollment of 5,500 women into its landmark Proteomic Assessment of Preterm Risk (PAPR) clinical study. The study has been conducted at eleven clinical centers across the U.S. and is designed to validate the performance of Sera's PreTRM™ test for the assessment of risk for preterm birth in women with singleton pregnancies.
"PAPR is the largest and broadest singleton proteomic study for the prediction of preterm birth performed to date in the U.S.," stated Durlin E. Hickok, M.D., M.P.H., Chief Medical Officer of Sera Prognostics. "This well-designed study of 5,500 patients will allow Sera to conduct rigorous validation of its preterm birth predictor. We appreciate the many talented investigators and their patients who participated in this important study and look forward to completing the analysis of the PAPR data."
Earlier data from patients who participated in the National Institutes of Health Preterm Prediction Study demonstrated the potential to predict preterm birth based on measurements of multiple proteins and protein fragments at 24 and 28 weeks of gestation. Sera's PAPR study builds upon this concept by nearly doubling the size of enrollment and working with a contemporary patient cohort that reflects the diversity of the current U.S. population. In addition, the PAPR study is also collecting samples earlier in pregnancy. Sera is using its advanced proteomic technologies to validate proprietary biomarker signatures that can reliably predict the risk that a woman could deliver preterm.
Sera's PAPR study closely adheres to the guidelines articulated in the Institute of Medicine's 2012 authoritative report, "Evolution of Translational Omics: Lessons Learned and the Path Forward". This report gives guidance on scientifically sound approaches that should be followed in performing clinical research to ensure reliable discovery and validation of proteomic algorithms for predicting clinical outcomes.
"We look forward to completing the final analysis of the PAPR study and validating the performance of our PreTRM™ predictor," said Gregory C. Critchfield, M.D., Chairman and Chief Executive Officer of Sera Prognostics. "This large study provides a strong foundation for Sera's development of a test that could help address the enormous economic and health consequences of preterm birth, with the ultimate goal of benefiting mothers and newborns worldwide."
Sera's preterm birth test will use a routine blood sample obtained during the second trimester of pregnancy to provide an early individualized assessment of a woman's risk of preterm birth. Upon launch, commercial testing will be performed at Sera's state-of-the-art CLIA laboratory with results returned to referring physicians. Physicians may then use this information to help guide clinical decisions with respect to personalized interventions intended to improve care and potentially reduce the costs of prolonged stays in neonatal intensive care units.
About the Study
The PAPR Study includes participating sites in Massachusetts, Delaware, North Carolina, South Carolina, Ohio, Tennessee, Utah, Texas, Arizona, California, and Oregon. Blood samples were prospectively collected from pregnant women between 17 and 28 weeks of gestation. All specimens are well-characterized based on delivery outcomes and both maternal and neonatal health. Sera's test is expected to measure concentrations of multiple protein biomarkers across several functional pathways that are relevant to preterm birth.
About Preterm Birth
Of the 4 million babies born annually in the U.S., approximately one in eight, or 12 percent, is born preterm. Preterm birth is the leading cause of illness and death in newborns and 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. A study published in 2006 by the Institute of Medicine and the March of Dimes reported that total costs incurred in the U.S. for treating complications of preterm birth exceed $26 billion each year. The complications from preterm birth also extend beyond the first year of life, and generate significant costs throughout the lives of affected children.
About Sera Prognostics, Inc.
Sera Prognostics is a private biotechnology company developing innovative diagnostic tests designed for the early prediction of preterm birth 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. In November 2011, the company completed a Series A financing round of $19.3 million to develop its preterm birth predictor. The company has assembled a strong management team and Board of Directors with significant clinical development and women's healthcare diagnostic experience. Sera 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