Salt Lake City, June 19, 2018 — Sera Prognostics, a women’s health company, announced today that the first patient has been enrolled in the AVERT PRETERM TRIAL. This is the second intervention study to use Sera’s PreTRM® test to identify women at high risk of early delivery that will receive proactive interventions with the goal of reducing the rate of premature delivery and improving newborn health. The principal investigator for the study is Matthew Hoffman, M.D., MPH, FACOG, Marie E. Pinizzotto, M.D., Endowed Chair of Obstetrics and Gynecology at Christiana Care Health System in Wilmington, Delaware.
According to the March of Dimes1 one in ten babies are born prematurely every year in the U.S. and 502 percent of these births have no known risk factors. Historically, physicians have lacked effective tools to identify the great majority of women who go on to have a premature baby.
“The AVERT PRETERM study is a major advancement in achieving Sera’s vision to improve neonatal and infant health. PreTRM is the only broadly validated blood test on the market today that can accurately predict a premature delivery. With the PreTRM test, a greater number of women who are truly at increased risk of premature delivery can potentially benefit from well-known interventions given early in pregnancy,” said Gregory C. Critchfield, M.D., M. S., chairman and chief executive officer of Sera Prognostics. “We are proud to be working with Christiana Care Health System, a leading healthcare system committed to improving the well-being of mothers and newborns.”
In May, Intermountain Healthcare announced that it launched the PREVENT PTB study that also uses the PreTRM® test to identify those at risk for premature birth. These two intervention studies will create data to support future insurance coverage and physician adoption for Sera’s PreTRM® test.
About AVERT PRETERM TRIAL
The AVERT PRETERM TRIAL is a prospective controlled intervention study comparing a test/treat arm, where high-PreTRM® risk patients receive intensive interventions, to a historical control arm whose patients did not receive PreTRM® testing, but received usual standard of care treatment. High-PreTRM® risk women will undergo more frequent and close monitoring by the care providers via Christiana’s remote tele-mentoring program called the Care-Link system, medications to potentially prolong gestation, and aggressive use of other interventions in response to early signs or symptoms that develop. The primary outcome of the study is a reduction in spontaneous preterm birth (sPTB), defined as spontaneous delivery before 37 weeks of pregnancy, in the test/treat population versus the historical control group. A number of secondary outcomes and observations include reduction in total preterm births, a reduction in total hospital stay for sPTB and reduction in total hospital stay for any preterm birth, neonatal morbidity measures and others. The study design is adaptive; according to pre-specified stopping criteria, the trial will end, with the anticipated number of patients enrolled being approximately 3,000. For more information, please visit ClinicalTrials.gov Identifier: NCT03151330.
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., 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 broadly 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 a global leader in high value women’s health diagnostics, delivering pivotal information to physicians to improve health and improve the economics of healthcare delivery for pregnant women. Sera is developing innovative diagnostic tests focused on the early prediction of preterm birth (PTB) risk and other complications of pregnancy. Sera’s PreTRM® test is available nationwide through the Company’s collaboration with LabCorp. PreTRM is the first and only broadly 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 strong management team has significant clinical development and women’s healthcare diagnostic experience. 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 Prognostics is located in Salt Lake City, Utah. For more information, please visit the company’s website at www.seraprognostics.com.
2 Iams J. Prevention of Preterm Parturition, N Engl J Med 2014; 370:254-61