Sera Prognostics Soars 205% as Trial is Halted Due to Efficacy
The Pregnancy Company®, Sera Prognostics Inc., (Nasdaq: SERA) has halted its pivotal Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal OutcoMEs (PRIME) study following advice from the Data Safety Monitoring Board (DSMB) providing oversight. The DSMB has recommended discontinuing enrollment due to efficacy and the company will now focus on analyzing and reporting the available data. The company’s share price rose 205% in morning trading following the news.
Zhenya Lindgardt, President and CEO of Sera Prognostics, commented, “We are excited by this report of efficacy from the DSMB. We look forward to sharing top-line results once we have had a chance to analyze the interim look data. We believe this will add to the PREVENT and AVERT studies in the growing, consistent body of evidence for our PreTRM® test that advances our mission to save lives and improve health for mothers and babies across the globe.”
Highlights
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.
Sera’s diagnostic test measures and analyzes proteins in the blood that are highly predictive of preterm birth. The test permits physicians to identify which women are at increased risk for preterm birth during the weeks 18 through 20 of pregnancy.
Preterm birth is defined as any birth before 37 weeks’ gestation and is the leading cause of illness and death in newborns. More than one in ten infants is born prematurely and is at 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.
About Sera Prognostics, Inc.
Sera Prognostics is a leading health diagnostics company dedicated to improving the lives of women and babies through precision pregnancy care. Sera’s mission is to provide early, pivotal pregnancy information to improve the health of mothers and newborns, 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 spontaneous premature delivery in a pregnancy, enabling earlier proactive interventions in women with higher risk. Sera Prognostics is headquartered in Salt Lake City, Utah.
