Benzinga | Nov 3, 2021 09:17AM EDT

Sera Prognostics Highlights Publication Of Clinical Validation Of PreTRM Threshold For Clinical Action

Sera Prognostics Inc., The Pregnancy Company(r) (NASDAQ:SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced the publication of a rigorous validation of a clinical decision point at spontaneous preterm birth (sPTB) risk of 15%, as determined by the Company's PreTRM(r) test.



In the Proteomic Assessment of Preterm Risk (PAPR) study, it was demonstrated that patients at or above 15% risk, or twice the intended use population risk, had significantly higher risk of sPTB. This risk threshold was independently validated in the Multicenter Assessment of Spontaneous Preterm Birth Predictor (TREETOP) study, a completely separate cohort of patients, demonstrating that risk stratification at or above this PreTRM(r) threshold significantly separates higher from lower-risk pregnancies. The study was conducted in accordance with the National Academy of Medicine's (NAM) guidelines for test development.

Furthermore, at or above the threshold, severe neonatal morbidity and/or mortality were significantly elevated. Identifying asymptomatic pregnancies at higher risk for sPTB and adverse maternal and neonatal outcomes is critical for reducing the enormous impact of preterm birth on health outcomes because it enables proactive interventions to occur in patients who are truly at higher risk. These new results were published in the peer-reviewed Journal of Clinical Medicine in an article entitled "Clinical Validation of a Proteomic Biomarker Threshold for Increased Risk of Spontaneous Preterm Birth and Associated Clinical Outcomes: A Replication Study." https://www.mdpi.com/2077-0383/10/21/5088

"The publication of these data adds to the growing body of evidence supporting the clinical validity and utility of Sera's PreTRM(r) test in identifying women at risk for sPTB and associated adverse neonatal outcomes. Sera's prospective intervention studies and health economic models are all based on a PreTRM risk threshold of approximately twice the average risk when testing is applied to populations," stated Gregory C. Critchfield, MD, MS, Chairman and CEO of Sera Prognostics. "We look forward to discussing the implications of these data as we engage with physicians, employers and payers in our efforts to improve pregnancy outcomes and reduce healthcare costs through expanded access to the PreTRM(r) test."

The study analysis involved the use of Sera's two large prospective clinical studies (PAPR and TREETOP), which enrolled over 10,000 subjects from 20 sites across the U.S.

Key findings of the analysis include the following for subjects with a PreTRM(r) score at or above the validated threshold:

* Significantly increased risk of sPTB

* Significantly increased risk of preterm birth occurring before 37, 35 and 32 weeks

* Significantly increased neonatal hospital length of stay

* Significantly increased maternal hospital length of stay

* Significantly increased severe neonatal outcomes

This validated threshold enables physicians to take action and implement a test-and-proactively-treat strategy in identifying women at risk for sPTB and offering evidence-based interventions to reduce risk, thus improving pregnancy outcomes while reducing the economic burden on payers, employers, and health care systems.