Wed, February 15, 2023 at 8:30 AM EST·6 min read
In this article:
PreTRM® test-and-treat strategy demonstrates statistically and clinically significant improvement in neonatal health outcomes and hospital length-of-stay
SALT LAKE CITY, Feb. 15, 2023 /PRNewswire/ – Sera Prognostics Inc., The Pregnancy Company® (NASDAQ: SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced top-line results from the AVERT PRETERM TRIAL (Serum Assessment of Preterm Birth Outcomes Compared to Historical Controls), conducted at ChristianaCare in Wilmington, Delaware.
Sera Prognostics, Inc.
Both co-primary outcomes—reduction of severe neonatal morbidity or neonatal death; and decreased length of neonatal hospital stay—met their endpoints, and the improvements in outcome with a PreTRM® test-and-treat approach were statistically significant. Detailed results of the AVERT PRETERM TRIAL analysis are being prepared for publication in a peer-reviewed journal.
“The AVERT PRETERM TRIAL results demonstrate the generalizability of the PreTRM® test-and-treat strategy in achieving meaningful clinical results in widely diverse U.S. populations,” said Gregory C. Critchfield, MD, MS, Chairman and CEO of Sera Prognostics. “Furthermore, these important AVERT PRETERM TRIAL clinical results build on and reinforce those of past studies—including PAPR, TREETOP and PREVENT-PTB. We believe the AVERT PRETERM TRIAL findings add to the growing body of evidence for the PreTRM® Test’s clinical benefit to mothers and babies, and that these new results bode well for our ongoing, large multi-center PRIME study.”
The PreTRM® Test was broadly developed and validated for prediction of spontaneous preterm birth (sPTB) in the U.S. in the Proteomic Assessment of Preterm Risk (PAPR) study. In a subsequent large prospective U.S. study, the Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor (TREETOP), the biomarkers were demonstrated to be predictive of very early preterm birth of any cause, neonatal length of hospital stay, and composite neonatal morbidity/mortality. Additional data published in May 2022 showed improved PreTRM® Test predictive performance for women whose due dates are more reliably determined by ultrasound.
About the AVERT PRETERM TRIAL
The AVERT PRETERM TRIAL evaluated the health benefit afforded to babies when pregnancies are screened with the PreTRM® Test and physicians intervened based on those results. An active arm of approximately 1,453 expectant mothers in the ChristianaCare in Delaware was tested in mid-pregnancy to stratify for increased risk of spontaneous preterm birth risk and those at higher risk were offered evidence-based interventions, which included care management, more intensive education, and medications. A historical control arm of approximately 10,000 patients was drawn from the immediate 2-year period before the trial enrollment began. Important neonatal outcomes that included total neonatal length of hospital stay and composite neonatal morbidity/mortality were analyzed in the active and historical control arms.