Sera Prognostics published results from a clinical utility and cost-effectiveness modeling study, which detailed the utility of PreTRM Test, a commercially available blood-based biomarker test that provides an early, accurate, and individualized risk prediction for spontaneous preterm birth in asymptomatic singleton pregnancies.

The newly published study—ACCORDANT (Analyses aCross Congruent studies ReDucing Adverse pregNancy ouTcomes)—reports:

  • Case management, which consists of increased outreach, education, and specialist care for women predicted to be at higher risk for delivering prematurely, was expected to decrease neonatal and maternal hospital length of stay by 19% (p=0.029) and 8.5% (p=0.001), respectively, compared with standard care.
  • Case management for those at higher risk also was predicted to significantly reduce moderate-to-severe neonatal morbidity and mortality by 29% (p=0.025).
  • Multimodal management, which combines case management with pharmacological treatment, was predicted to further improve outcomes and statistical significance
  • The modeled clinical benefits and cost-effectiveness of the test-and-treat strategies were seen across diverse racial and ethnic backgrounds, with Black and Hispanic women strongly represented in the study.

“Results of this analysis point to the utility of the PreTRM test-and-treat strategy in ameliorating the clinical and economic effects of preterm delivery, which impacts more than 10% of U.S. births each year,” says Gregory C. Critchfield, MD, MS, chairman and CEO of Sera Prognostics. “Most importantly, the predicted benefits across underserved populations, among whom the prevalence of preterm birth is disproportionately increased, provide the opportunity to serve a broad and diverse population of women in the United States. We are excited to be in a position to help substantively address unacceptable healthcare disparities in pregnant populations that unfortunately bear the burdens of prematurity.”

ACCORDANT was a secondary analysis of 847 women from the Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor study (TREETOP), a previously published evaluation of the predictive performance of the PreTRM Test. The study combined real-world clinical information with large, published outcomes datasets in a microsimulation model to examine the potential impacts of the test-and-treat strategies on important clinical indicators and medical costs related to preterm birth.

“By combining the PreTRM Test, which detects far more women at risk of preterm birth than traditional clinical factors, with enhanced prenatal case management, real progress may be possible for this under-addressed and serious condition,” says Michael Foley, MD, Sera’s chief medical officer.

Sere Prognostics is focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients,

The peer-reviewed report, “Clinical and economic evaluation of a proteomic biomarker preterm birth risk predictor: Cost-effectiveness modeling of prenatal interventions applied to predicted higher-risk pregnancies within a large and diverse cohort,” was published in the Journal of Medical Economics.