Sera Prognostics Announces Publication of Data Confirming the Performance of the Ibp4/shbg Biomarkers in Diverse Non-U.S. Populations
Results confirmed that a U.S. validated proteomics predictor could be applied in low and middle income countries to help address global preterm birth challenges
Salt Lake City, – December 1, 2021 – 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 the publication of a study funded by the Bill & Melinda Gates Foundation and in collaboration with AMANHI (Alliance for Maternal and Newborn Health Improvement), a multinational effort to improve health for pregnant and postpartum women and their babies in sub-Saharan Africa and South Asia. The newly published article presents the performance of the IBP4/SHBG biomarker pair in predicting spontaneous preterm birth (sPTB) in low and middle income geographies, with prespecified adjustment for demographic differences between the populations.
“Sera is committed to addressing the global challenges of premature births,” said Gregory C. Critchfield, MD, MS, Chairman and CEO of Sera Prognostics. “The data published today demonstrate that our biomarkers can be used to predict sPTB in patient populations with baseline demographics and health care access that are distinct from those of U.S. populations in which they were initially validated. We believe that these data warrant careful consideration by all stakeholders who seek to improve maternal and neonatal outcomes and support the further evaluation of these biomarkers in additional populations.”
The PreTRM® test was developed and validated for prediction of spontaneous preterm birth (sPTB) broadly in the U.S. in the Proteomic Assessment of Preterm Risk (PAPR) study. The biomarkers were subsequently shown to be predictive of very early preterm birth of any cause, length of neonatal hospital stay, and neonatal morbidity and mortality in a second large prospective U.S. study, the Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor (TREETOP) study. Now, analysis of biomarker performance in AMANHI samples, published in the peer-reviewed Journal of Maternal-Fetal & Neonatal Medicine in an article entitled “Performance of a validated spontaneous preterm delivery predictor in South Asian and sub-Saharan African women: a nested case-control study”: https://doi.org/10.1080/14767058.2021.2005573 demonstrates confirmation of PreTRM biomarker predictive performance for prematurity with prespecified adjustment for expected demographic differences in populations outside of the United States.
The AMANHI biobanking study enrolled 10,001 pregnant women in Bangladesh, Pakistan, and Tanzania from whom a nested case control analysis was conducted in 298 representative pregnancies. This work demonstrated that IBP4 and SHBG, the biomarkers utilized by the U.S. PreTRM® test, after prespecified adjustment for expected demographic differences between the populations, significantly predicted sPTB. As was demonstrated in the U.S. studies, the biomarkers performed well for prediction of sPTB <37 weeks and for earlier more severe preterm births. The new publication further demonstrates the strength of Sera’s artificial intelligence pipeline by the identification of a limited number of additional biomarkers that complement IBP4 and SHBG biomarker in predictive performance for prematurity in this diverse cohort with blood draws earlier in gestation. The IBP4/SHBG biomarker pair may have broader application for predicting sPTB in diverse non-U.S. populations.