SALT LAKE CITY, Utah, Feb. 28, 2013 (GLOBE NEWSWIRE) -- Sera Prognostics, Inc., a women's health company, today announced that its Proteomic Assessment of Preterm Risk (PAPR) clinical study has now exceeded enrollment of 4,000 subjects, making it the largest broad prospective cohort trial focused on proteomic preterm birth prediction. The Company initiated the PAPR study in 2011 to establish a large proprietary biobank to support the development and clinical validation of its maternal-fetal medicine diagnostic testing programs.
Sera's PAPR Study is a validation study that builds upon the original NICHD Maternal-Fetal Medicine Units Network Preterm Prediction Study, which reported the initial discovery of a novel, high performing preterm birth predictor in the May 2011 issue of American Journal of Obstetrics & Gynecology. With enrollment of the PAPR study exceeding 4,000, the combined number of patients forming the basis for Sera's discovery/verification and clinical validation of its preterm birth test now totals over 7,000--making it the broadest combined population sample set dedicated to the question of preterm birth prediction in the U.S.
"We thank the talented principal investigators and site personnel at the prominent institutions participating in the PAPR study for their commitment to the research of preterm birth," said Durlin E. Hickok, M.D., M.P.H., Chief Medical Officer of Sera Prognostics. "The selection of these study sites reflects the diverse demographics of pregnant women across the U.S. and includes high concentrations of vulnerable populations at higher risk of preterm birth."
Sera is in the process of building a scientifically sound and clinically and economically meaningful predictor of preterm birth risk by:
- using a broad and representative discovery/validation sample set,
- following the rigorous guidelines articulated in the Institute of Medicine's capstone report, "Evolution of Translational Omics: Lessons Learned and the Path Forward," and
- applying the company's proprietary advanced proteomic science technologies.
"With the tools available to us today, physicians are unable to predict the large majority of women who will eventually deliver preterm," said Kim Boggess, M.D, Professor of Obstetrics and Gynecology at the University of North Carolina, Chapel Hill, a principle investigator in the PAPR study. "While new advances in molecular diagnostics offer possible strategies to improve risk assessment, it is critically important that the validity of new prediction tools be supported by solid data from large, well-designed clinical studies that are representative of the intended patient populations. I applaud Sera for its rigorous scientific approach to demonstrating the performance of its preterm birth risk predictor through both a robust and geographically diverse clinical trial."
Sera's preterm birth test is designed to use a routine blood sample obtained during the second trimester of pregnancy to provide an 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 and results returned to referring physicians. Physicians may then use this information to help guide clinical decisions with respect to personalized interventions intended to improve clinical care and potentially reduce the costs of prolonged stays in neonatal intensive care units.
"Having worked with a number of maternal-fetal medicine and OB/GYN experts to design and conduct Sera's large prospective clinical study, we are excited at the prospect of the information it will uncover," said Gregory C. Critchfield, M.D., M.S., Chairman and Chief Executive Officer of Sera Prognostics. "With nearly 500,000 infants born prematurely in the U.S. each year and the staggering costs of associated care, it is critical that physicians be enabled to understand who is most at risk and how they might be able to better prevent preterm birth. Having enrolled more than 4,000 subjects in the PAPR study is a tremendous accomplishment. We look forward to completing this second validation study by mid-year 2013 and expect that PAPR will provide definitive data on Sera's predictor."
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 are being prospectively collected from pregnant women between 17 and 28 weeks of gestation and are tracked by delivery outcome and both maternal and neonatal health. Sera's test measures concentrations of multiple protein biomarkers across several functional pathways of relevance to preterm birth. In May 2011, the initial proteomic discovery work that provides the foundation for the identification of novel biomarkers for the prediction of preterm birth was published in the American Journal of Obstetrics and Gynecology.
The PAPR study completion is expected in the second half of 2013 when results will also be announced.
About Preterm Birth
Of the 4.1 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, mental retardation, 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 novel diagnostic tests designed for the early prediction of preterm birth and other pregnancy complications, such that personalized and effective care interventions can be provided. These innovative tests have the potential of improving the health of both mothers and infants. In November 2011, Sera 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 currently completing the world's largest clinical biomarker study focused on the validation of its test for predicting the risk of preterm birth. Sera is located in Salt Lake City, Utah. For more information, please visit the company's website at www.seraprognostics.com.