– Patient enrollment began in November for this rigorous prospective, randomized, controlled PRIME intervention trial to demonstrate the value of implementing the PreTRM® prevention strategy to improve neonatal outcomes and lower cost of care-
SALT LAKE CITY, January 5, 2021 (GLOBE NEWSWIRE) — Sera Prognostics, Inc., The Pregnancy Company™, focused on improving maternal and neonatal health through innovative precision biomarker approaches, together with leading health benefits company Anthem, Inc. and its HealthCore, Inc. subsidiary, an evidence generation company, have launched and started to enroll patients in a study to determine whether a test, along with clinical interventions, can lead to improved health for newborns and mothers.
The primary objective of the Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal OutcoMEs (PRIME) study is to evaluate how pairing the PreTRM® test, used to identify pregnant women who are at higher risk of delivering preterm, with clinical interventions may mitigate that risk and improve neonatal outcomes and reduce overall healthcare costs in this population.
Preterm birth is defined as any birth before 37 weeks gestation and is the leading cause of illness and death in newborns. The 2020 March of Dimes Report Card shows that of nearly 4 million babies born annually in the U.S., more than one in 10 is born prematurely.
The PRIME study is designed to measure the impact of a test and intervention on outcomes and costs, and provide a blueprint for how the healthcare industry can more effectively identify and manage high-risk pregnancies and reduce preterm birth. When combined with the previous results of the health economics and outcomes research projects conducted by HealthCore, this study will provide payers with the necessary generalizable data to assess the value of implementing a test and treat strategy intended to improve birth outcomes.
“The effects of preterm birth on mothers, babies, employers and communities are devastating,” said Marcus Wilson, Anthem’s chief analytics officer. “We’re hoping clinicians can use information generated by the completed study to implement the test and associated clinical interventions in their practices to improve outcomes and lower costs.”
The PRIME study follows an initial claims analysis by HealthCore indicating that the test had promise to improve outcomes and lower costs. Conducted within the Anthem affiliated health plan network, PRIME will include approximately 5,600 women across diverse patient profiles, geographies, and ethnicities to determine generalizable impacts to pregnant women enrolled in Anthem individual, employer-sponsored, commercial and Medicaid health plans.
“It is important to Anthem that the PRIME study include diverse groups so we can have a better understanding of how Sera’s innovative test and treatment strategies work for all of the populations our company serves,” said Laura Herrera Scott, M.D., vice president, clinical strategy and services at Anthem, Inc. “There are limited proven solutions for preterm birth prevention, so we are enthusiastic about partnering and investing in Sera Prognostics and the PRIME study to determine if we can drive innovations to improve the well-being of mothers and their newborns with an evidence-based, insight-driven approach.”
Maternal-fetal medicine expert Brian K. Iriye, MD, of the High Risk Pregnancy Center in Las Vegas and Reno, Nevada, is the lead investigator on the PRIME study. HRPC is the first of approximately 10 leading maternal-fetal medicine institutions across the country to enroll patients in this study.
The PRIME protocol is based on using the risk stratification by Sera’s PreTRM® test, the only clinically validated, commercially available blood test to provide an early individual risk prediction for spontaneous preterm delivery in asymptomatic, singleton pregnancies. Anthem will cover the utilization cost of the PreTRM® test for those assigned to the intervention arm of the randomized clinical study.
“Prematurity remains the primary driver of neonatal morbidity, mortality, and healthcare costs in pregnancy,” said Gregory C. Critchfield, MD, MS, chairman and chief executive officer of Sera Prognostics. “We are pleased to partner with Anthem and HealthCore to address the ongoing U.S. healthcare crisis of prematurity, as we continue demonstrating the clinical value and cost savings that result from the implementation of Sera’s PreTRM® test/treat strategy. Anthem’s forward-looking approach to helping improve the health of women and children is commendable.”
About Anthem, Inc.
Anthem is a leading health benefits company dedicated to improving lives and communities and making healthcare simpler. Through its affiliated companies, Anthem serves more than 107 million people, including approximately 43 million within its family of health plans. We aim to be the most innovative, valuable and inclusive partner. For more information, please visit www.antheminc.com or follow @AnthemInc on Twitter.
About Sera Prognostics, Inc.
Sera Prognostics is the leading health diagnostics company dedicated to improving the lives of women and babies through precision pregnancy care. Sera delivers pivotal information in early pregnancy to physicians, enabling them to improve the health of their patients, resulting in reductions in the costs of healthcare delivery. Sera has a robust pipeline of innovative diagnostic tests focused on the early prediction of preterm birth risk and other complications of pregnancy. Sera’s precision medicine PreTRM® test reports to a physician the individualized risk of premature delivery in a pregnancy, enabling earlier proactive interventions in women with higher risk. Sera Prognostics is located in Salt Lake City, Utah. For more information, please visit the company’s website at www.seraprognostics.com.
About HealthCore, Inc.
HealthCore is finding evidence and truth at the core of healthcare. We work with life sciences companies, government, payors, and collaborators on a broad range of research services focused on informing key decision makers. As the wholly owned, independently operating subsidiary of Anthem, Inc., we utilize a powerful research ecosystem of expertise, relationships, and data to generate the evidence needed to improve healthcare. To learn more about HealthCore, visit www.healthcore.com.
About Preterm Birth
Preterm birth is defined as any birth before 37 weeks gestation and is the leading cause of illness and death in newborns. The 2020 March of Dimes Report Card shows that of nearly 4 million babies born annually in the U.S., more than one in ten is born prematurely.1 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, vision and hearing loss, and can generate significant costs throughout the lives of affected children. The annual U.S. health care costs to manage complications of prematurity were estimated at $31.5B for 2015.2
About the PreTRM® Test
The PreTRM® test is the only clinically validated commercially available blood test that provides an early 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 permits physicians to identify, as early as 19 weeks of pregnancy, which women are at increased risk for premature delivery, enabling more informed clinical decisions based on each woman’s individual risk, so that her care can be personalized to address her risk. The PreTRM® test is ordered by a medical professional. For more information, please visit www.PreTRM.com and the PreTRM® test YouTube Channel. You can also join the conversation on Facebook and @PreTRM on Twitter.
About Sera’s Science
Using its advanced mass spectrometry platform, Sera detects biologically important protein abundance differences to build high performing predictions of risk for adverse pregnancy outcomes (including preterm birth, preeclampsia, gestational diabetes, growth restriction, and others). Rigorous clinical validation of PreTRM® test performance (accuracy of predicting premature delivery) was reported in the American Journal of Obstetrics & Gynecology in 2016 in a US cohort of 5,501 patients across 11 centers. Sera’s biomarker predictions have been studied with leading scientific collaborators in patient cohorts from the U.S., Europe, Asia and Africa.
About Clinical Outcomes Studies
Sera’s validated PreTRM® prediction testing has been taken into prospective intervention studies, where populations of pregnant women have been screened by the Sera test. Women at higher PreTRM® risk and not otherwise identifiable receive interventions, and important outcomes are examined in comparison to pregnancies in control groups where the test is not available.
Topline results showing the benefit of the PreTRM® strategy in a recently completed randomized controlled prospective intervention study (PREVENT PTB Study, NCT03530332) became available online for the Late Breaking Poster Session of the March 2020 Annual Meeting of the Society of Reproductive Investigation, in Vancouver, Canada.
2 Caughey et al., Am J Perinatol Rep 2016;6:e407-e416.