Landmark Study Published in American Journal

The PreTRM^® Test is Now Commercially Available to Predict Risk Early in Pregnancy

SALT LAKE CITY, March 10, 2016 – Sera, Inc., a women’s healthcare company, today announced that clinical validation data from the 5,501 patient Proteomic Assessment of Preterm Risk (PAPR) study were published online in the American Journal of Obstetrics & Gynecology. The article presents the performance in a rigorous clinical validation of Sera’s PreTRM^® test for objectively and accurately predicting the risk of spontaneous preterm birth (sPTB) in asymptomatic pregnant women as early as 19 weeks of pregnancy.

The PreTRM test, now commercially available nationwide, is the first and only clinically validated blood test of its kind, based on a large prospective clinical study that is representative of single birth pregnancies occurring in the U.S.

Premature birth (defined as birth before 37 weeks) is the leading cause of death for newborns worldwide. According to the Centers for Disease Control and the March of Dimes, each year in the United States, approximately one in ten babies are born too early, and more than half of these premature babies are born to mothers with no known risk factors. In premature infants who survive, prematurity is a leading cause of long-term medical complications, including learning disabilities, cerebral palsy, chronic respiratory illness, intellectual disability, seizures, and vision and hearing loss. The costs of treating complications of premature birth in the U.S. were greater than $26B in 2005, with current costs estimated to be much higher.

“To date, physicians have had limited tools and methods to identify women who are at increased risk of preterm birth. The two best traditional predictors, prior preterm birth history or short cervical length, identify only a small percentage of women who deliver early. The great majority of women delivering prematurely present in labor, when options for managing their pregnancies are late and quite restricted,” said John Elliott, MD, maternal-fetal medicine expert and Medical Director, Valley Perinatal Services, Phoenix, AZ. “The data supporting the PreTRM test, now published in AJOG, give clinicians confidence that this test can help identify a high percentage of these women who are at increased risk early in pregnancy before symptoms occur. Using the PreTRM test provides information I need to be proactive with pregnancies at increased risk and make more informed decisions in managing those pregnancies.”

The PAPR 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, using a novel proteomic approach, and rigorously adhering to the authoritative Institute of Medicine guidelines for Omics prediction development. The outstanding performance of the proprietary classifier was independently validated, achieving an area under the ROC curve of 0.75 for delivery occurring before 37 weeks of pregnancy, and higher performance for predicting delivery occurring earlier (before 36 or 35 weeks of pregnancy), achieving statistical significance for each of the three predictions. These validation results show that the PreTRM test is statistically accurate in predicting the risk of sPTB in pregnant women as early as 19 weeks of pregnancy.

“As a company, Sera is focused on addressing the enormous economic and healthcare burden that premature birth places on infants, their families and societies around the world.” said Gregory Critchfield, M.D., CEO of Sera. “We believe that the PreTRM test will become an important tool to identify women at high risk of delivering prematurely, so that earlier, proactive interventions become possible. Early in pregnancy, the PreTRM test improves the ability of doctors to determine who is at high risk, helping them to make more informed decisions in managing the risks of women who need greater attention. Building on Sera’s innovative approaches, we are committed to improving neonatal health globally, through our direct participation in scientific studies, both in the U.S. and in underserved countries.”

About the Proteomic Assessment of Preterm Risk (PAPR) Study

The PAPR study enrolled 5,501 pregnant women at 11 sites in the U.S. between 2011 and 2013. Sera scientists identified an optimal gestational age window during pregnancy at weeks 19 and 20, in which a two-protein signature (IBP4 and SHBG) was found to be highly predictive of spontaneous preterm birth. Following the discovery, verification and final development of the signature, the PreTRM test was validated in blood samples taken from an independent group of women. The results showed excellent prediction of preterm birth occurring before 37 weeks of pregnancy, and even higher predictive performance for delivery occurring before 36 and 35 weeks of pregnancy.

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, approximately one in ten 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 significantly increased risks of major long-term medical complications, including learning disabilities, cerebral palsy, chronic respiratory illness, intellectual disability, seizures, and vision difficulties 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 an innovative new blood test that provides an early and individual risk prediction for spontaneous preterm birth 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 increased risk for early delivery, enabling more informed management decisions based on each women’s individual risk. 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 and the PreTRM test YouTube Channel. You can also join the conversation on Facebook and @PreTRM.

About Sera, Inc.

Sera 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 & 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 & Melinda Gates Foundation to translate its discoveries and develop technologies to benefit women and infants in underserved countries worldwide. Sera is located in Salt Lake City, Utah. For more information, please visit the company’s website at www.sera.com.

Company Contact:
Andrew Sauter, CFO
Sera, Inc.
info@seraprognostics.com
(801) 990-0772

Media Contact for Sera
Terri Clevenger
Continuum Health Communications
tclevenger@continuumhealthcom.com
(203) 856-4326