Sera Prognostics Inc. announced that the Data Safety Monitoring Board (DSMB) overseeing its pivotal Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal OutcoMEs (PRIME) study recommended stopping enrollment due to efficacy, reporting that either of the co-primary endpoints met the stopping criteria for statistical significance at the pre-planned interim analysis. The company has adopted the DSMB's recommendation and will stop PRIME study enrollment to focus on analyzing and reporting the available data. Preterm birth is defined as any birth before 37 weeks' gestation and is the leading cause of illness and death in newborns.
The 2022 March of Dimes Report Card shows that, for the last four consecutive years, more than one in ten infants is born prematurely. 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. The annual health care costs to manage short- and long-term complications of prematurity in the United States were estimated to be approximately $25 billion for 2016.
The PreTRM Test is the only broadly validated, commercially available blood-based biomarker test that provides an early, accurate and individualized 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, during the weeks 18 through 20 of pregnancy, which women are at increased risk for preterm birth and its complications, enabling more informed, clinical decisions based on each woman's individual risk.
The PreTRM Test is ordered by a medical professional.