Sera Prognostics Announces Completion Of Important Prevent PTB Clinical Intervention Study Using The Pretrm® Test
SALT LAKE CITY – January 9, 2020 – Sera Prognostics, Inc., the leading health diagnostics company dedicated to improve the lives of women and babies through individualized prenatal care, today, announced that the Prevent PTB clinical study conducted by Intermountain Healthcare is being prepared for publication in a peer-reviewed scientific journal. This study is the first of its kind to measure the impact on maternal and neonatal health and healthcare costs when standard medical interventions are used to proactively treat mothers screened at high risk for prematurity by the PreTRM® Test. (ClinicalTrials.gov Identifier: NCT03530332)
Prevent PTB, a prospective randomized-controlled clinical intervention study, assessed the benefit of identifying women at higher risk of preterm delivery using Sera’s innovative PreTRM® test coupled with proactive interventions to address the risks in these pregnancies. The study measured the effect on reducing preterm birth rates, the differences in lengths of stay in the neonatal intensive care unit (NICU) and in the hospital; and the overall cost of the pregnancy and delivery.
“We are very pleased to have this important study worked on by leading maternal fetal medicine experts at Intermountain Healthcare, who have conducted this research to address the enormous problem of preterm delivery,” said Gregory C. Critchfield, MD, MS, Chairman and Chief Executive Officer of Sera. “Intermountain’s exemplary commitment to personalizing care to improve outcomes and reduce the impact of prematurity serves as a beacon to other health systems, as we all work together to address the national plague of preterm birth.”
Final results of the Prevent PTB study are being prepared for presentation and publication in early 2020.
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 nearly 4 million babies born annually in the U.S., one in ten is born prematurely.1 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. Approximately $32B of expense occurs annually in the US as a result of premature birth. 2
About the PreTRM® Test
The PreTRM® test is the only clinically-validated blood test that provides an early and individual risk prediction for spontaneous preterm birth in asymptomatic, singleton pregnancies. 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 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 Prognostics, Inc.
Sera Prognostics is the leading health diagnostics company dedicated to improve the lives of women and babies through individualized prenatal care. Sera delivers pivotal information to physicians to improve health and to improve the economics of healthcare delivery for pregnant women. Sera is developing innovative diagnostic tests focused on the early prediction of preterm birth risk and other complications of pregnancy. Sera’s PreTRM® test objectively reports to a physician the risk of a woman’s premature delivery, enabling earlier proactive interventions designed to improve the health of her baby. Sera’s strong management team has significant clinical development and women’s healthcare diagnostic experience. Sera is working with other researchers to demonstrate the impact of additional interventions to improve pregnancy outcomes when used in connection with the PreTRM® test to stratify risk of prematurity. Sera Prognostics is located in Salt Lake City, Utah. For more information, please visit the company’s website at www.seraprognostics.com.
1 http://www.marchofdimes.org/mission/prematurity-reportcard.aspx
2 Caughey et al, Am J Perinatol Rep 2016;6:e407-e416