Highlighting Clinical Utility of PreTRM® Test

Experts Predict a Reduction of Infant Mortality by 23.5% and Annual Direct Medical Costs of More Than $500 million Through Preterm Birth Risk Testing

SALT LAKE CITY, December 19, 2016 – Sera, Inc., a women’s healthcare company, today announced the recent publications of two reports showing significant clinical utility of assessing preterm birth risk early in pregnancy with novel biomarker tests. These reports describe treatment paradigms that use existing interventions with significant potential to improve the health of premature babies, including reduction in mortality rates, as well as a corresponding reduction of direct medical costs to the health care system.

“These important publications analyze better ways to address the severe health and economic impact of prematurity on US families,” stated Gregory C. Critchfield, MD, MS, Chairman and CEO of Sera, “and demonstrate the value of knowing early in pregnancy a woman’s risk for premature delivery. By using interventions earlier, physicians can seek to prolong pregnancies as a strategy to improve the chances of healthier babies. Sera is proud to offer the PreTRM^® test, the only clinically validated blood test for the early prediction of preterm birth risk, as we work to make the company’s vision a reality: To improve the health of women and infants and decrease the costs of healthcare worldwide.”

A comprehensive analysis conducted by a group of noted health economists entitled,

Clinical and Cost Impact Analysis of a Novel Prognostic Test for Early Detection of Preterm Birth, was published in the American Journal of Perinatology Reports, and available at https://www.thieme-connect.de/products/ejournals/pdf/10.1055/s-0036-1593866.pdf . The authors concluded that “the use of a prognostic test for reducing spontaneous preterm birth is a dominant strategy that could reduce costs and improve outcomes.” Other findings from the report state that preterm birth risk testing and intervention could result in:

23.5% reduction in infant mortality (approximately 2,000 fewer neonatal deaths per year)
27.7% reduction in acute conditions at birth
23,430 fewer preterm births per year
$511 million reduction in direct medical costs to the US healthcare system from preterm infants in the first year of life

“The clinical and financial impact of preterm birth continues to increase and contribute to the rising cost of healthcare in the US,” said Jay D. Iams, MD, Emeritus Professor of Obstetrics and Gynecology at The Ohio State University College of Medicine. “The outcome of our in-depth analysis showed the potential significance of a novel prognostic test such as PreTRM^®, to improve neonatal health and achieve subsequent reduction of overall costs of preterm birth on the healthcare system.”

A separate article entitled Preterm Birth: can we do better? was published in Proceedings in Obstetrics and Gynecology, and is available at http://ir.uiowa.edu/cgi/viewcontent.cgi?article=1307&context=pog. The authors present a clinical treatment protocol for testing women early in pregnancy with a validated biomarker test for preterm birth risk, and administering recommended interventions based on a woman’s individual risk. The paper discusses:

The clear need to validate biomarkers that provide quantitative, individualized assessment of risk early in pregnancy.
That physicians must increase efforts to optimize current treatments and invest in the development of new interventions and focus on incremental improvements in neonatal health and cost reduction.
Beneficial interventions for high risk women that include screening and treatment for cervical shortening or infection, referrals to maternal-fetal specialists, progesterone therapies, and other treatments such as tocolysis and steroids.

Scott A. Sullivan, MD, MSCR, Professor and Division Director of Maternal-Fetal Medicine at the Medical University of South Carolina, stated “For the first time, our team of experts have recommended a treatment algorithm that suggests increased use of a range of interventions, based on a woman’s individual risk prediction from a validated biomarker test, now available, that all doctors can follow with the goal of improving neonatal outcomes.”

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., 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. Prematurity 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, and can generate significant costs throughout the lives of affected children.

About the PreTRM^® Test

The PreTRM^® test is the first and only clinically validated blood test that provides an early and individual risk prediction for spontaneous preterm birth in asymptomatic, singleton pregnancies. Using proteomic technology, the PreTRM^® test measures and analyzes proteins in the blood that are highly predictive of preterm birth. The PreTRM^® test can help physicians identify early in the pregnancy (as early as 19 weeks of gestation) which women are at increased risk for premature delivery, enabling more informed clinical decisions based on each woman’s individual risk. The PreTRM^® test enables researchers to better understand the causes of preterm birth and to develop new therapies to improve newborn health.

The PreTRM^® test is ordered by a medical professional.

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, a women’s health company, develops innovative diagnostic tests focused on the early prediction of preterm birth (PTB) risk and other complications of pregnancy. Sera has launched its PreTRM^® test, the first and only clinically validated blood test to accurately predict early in pregnancy the risk of premature birth. The test objectively reports to the physician the risk of premature delivery, enabling earlier proactive interventions designed to prolong gestation and improve neonatal health outcomes. Sera’s proprietary technology addresses both the health and economic challenges of PTB. The Company’s strong management team has significant clinical development and women’s healthcare diagnostic experience. Sera is backed by highly respected healthcare investors, including Domain Associates, InterWest Partners, Catalyst Health Ventures, and the Bill & Melinda Gates Foundation. Currently, Sera is working with the Gates Foundation to translate the Company’s discoveries into technologies well suited for low-income countries in its journey to improve maternal and infant health globally. 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