Sera Prognostics Announces Positive Data from Second Study of Preterm Birth Test

/ Source: GlobeNewswire

SAN FRANCISCO, Feb. 12, 2011 (GLOBE NEWSWIRE) -- Sera Prognostics, Inc., a women's health company developing diagnostic tests for early prediction of preterm birth and other pregnancy complications, today announced that preliminary analyses of data from a second study of predictive preterm birth biomarkers generally confirmed researchers' earlier results and were able to identify up to 92 percent of pregnant women who went on to have a preterm birth. Results from this second study were presented today at the Society for Maternal-Fetal Medicine's (SMFM) annual meeting held in San Francisco. Sera has licensed the novel peptide biomarkers used in the study.

A previous blinded, case-controlled study demonstrated that three novel peptides, in combination with additional biomarkers, were highly predictive of preterm birth risk when tested at 24 and 28 weeks of gestation. That initial study was recently published online in the American Journal of Obstetrics & Gynecology (). Both preterm birth studies were performed using blood samples and other clinical data collected during the National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network Preterm Prediction Study.

"The current analyses from the second study strongly support the previous findings that these novel peptides may help physicians identify women at risk for preterm birth prior to any observable symptoms, and allow physicians to make more informed decisions about treatments to manage and potentially extend at-risk pregnancies," said Steven W. Graves, Ph.D., co-author and presenter of the study for the Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units Network. "By identifying preterm birth risk earlier in a pregnancy, physicians and their patients may have greater opportunity to implement treatments and manage their care to reduce the risk of serious health complications and lower the significant cost of care for both mother and baby."

About the Study

Blood samples collected at 24 and 28 weeks gestation during the NICHD Maternal-Fetal Medicine Units Network Preterm Prediction Study were used to create the blinded set of cases and controls. Two separate laboratories performed the serum proteomic analysis using a liquid chromatography mass spectrometry proteomics method. When comparing the analyses from the two separate laboratories, the combination of the three novel peptides and additional biomarkers provided up to 92 percent sensitivity (accurate prediction of preterm birth, or early delivery before 35 weeks gestation) and up to 86 percent specificity (accurate prediction of those who were not at risk for early delivery).

"With more than one-half million early deliveries in the U.S. each year, the associated costs of caring for these babies is tremendous," said Kenneth Chahine, Ph.D., J.D., president and chief operating officer of Sera Prognostics. "We believe Sera can help improve the health of newborns and reduce the economic burden on the healthcare system and families by identifying the risk of preterm birth earlier in pregnancy. We are taking steps to develop a commercially viable test and provide a useful tool to clinicians in the field who are working to improve delivery outcomes."

About Preterm Birth

Of the 4.5 million births per year in the U.S., approximately 1.2 million are considered to be at high risk of preterm birth, and approximately one in eight babies, or 12 percent, are born premature each year. Preterm birth is the leading cause of illness and death associated with newborns, with a significantly increased risk of major long-term childhood medical complications such as learning disabilities, seizures, mental retardation, cerebral palsy, chronic respiration illness, and vision and hearing loss. According to a study by the March of Dimes, the annual public healthcare cost of caring for preterm infants in the U.S. is over $26 billion. Additional lifetime costs for children with preterm birth-related medical complications is estimated at approximately $500,000 per child.

About Sera Prognostics

Sera Prognostics is a private biotechnology company developing diagnostic tests that use proprietary biomarkers that are predictive of preterm birth and other pregnancy complications. Sera was founded in 2008 and licensed its serum proteomics discovery technology and novel peptides from Brigham Young University and the University of Utah. The company has assembled a board of directors and management team with significant clinical development and women's healthcare diagnostic experience for translating scientific innovation into commercial products that help patients and build significant corporate value. Sera is located in Salt Lake City, Utah. For more information, please visit the company's website at .

About SMFM

The Society for Maternal-Fetal Medicine (est. 1977) is a non-profit membership group for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine. The society is devoted to reducing high-risk pregnancy complications by providing continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods. It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine. The group hosts an annual scientific meeting in which new ideas and research in the area of maternal-fetal medicine are unveiled and discussed. For more information, visit .

CONTACT: Company Contact: Andrew Sauter Sera Prognostics - CFO (925) 367-4042 Media Contact: Stephanie Ashe Continuum Health Communications (650) 728-7087