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 presented data demonstrating the effective prediction of preeclampsia using protein biomarkers and clinical factors. The presentation titled “Comparison of Protein Biomarkers to Clinical Factors for Preeclampsia in Two Cohorts” was given by lead author Julia Burchard et al this morning at the 69th Annual Meeting of the Society for Reproductive Investigation (SRI) in Denver, Colorado, during Late Breaking Session LB-002 from 9:00-10:30 AM.
This study was a secondary analysis of two large independent pregnancy cohorts totaling more than 10,500 enrolled patients, PAPR (NCT01371019; 11 U.S. sites, 2011-2013) and TREETOP (NCT02787213; 18 U.S. sites, 2016-2018) investigating the ability of 6 clinical factors and 31 protein biomarkers to predict either preeclampsia at any gestational age or preterm preeclampsia occurring before 37 weeks of pregnancy in women prior to receiving a clinical diagnosis of preeclampsia. Of the 6 clinical factors, only having had preeclampsia in a prior pregnancy was significantly predictive of both outcomes in both studies. Of 31 biomarkers, significant prediction of preeclampsia and preterm preeclampsia was shown by 7 and 5 biomarkers, respectively, in both studies. Biomarkers, paired with the clinical predictor preeclampsia in a previous pregnancy, showed additive predictive performance and contributed more strongly for prediction of preterm preeclampsia. Biomarkers alone, whether or not clinical factors are available, also showed independent predictive performance of preeclampsia, enabling more timely interventions designed to address a patient’s individual risk.
“We are pleased to have this important study completed on preeclampsia, a major cause of prematurity and neonatal and maternal health complications,” said Gregory C. Critchfield, MD, MS, Chairman and Chief Executive Officer of Sera Prognostics. “This study, conducted by leading researchers in maternal-fetal medicine, demonstrates progress on our pipeline and our ongoing commitment to providing valuable information to doctors and pregnant women in Sera Prognostics’ journey as The Pregnancy Company.”
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 deliver early, pivotal information in pregnancy to physicians, enabling them to improve the health of their patients, 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 located in Salt Lake City, Utah
About Preterm Birth
Preterm birth is defined as any birth before 37 weeks’ gestation and is the leading cause of illness and death in newborns. The 2021 March of Dimes Report Card shows that more than one in ten infants is born prematurely. Prematurity is associated with 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, and can generate significant costs throughout the lives of affected children. The annual health care costs to manage short- and long-term complications of prematurity in the United States were estimated to be approximately $25 billion for 2016.
About the PreTRM® Test
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. The PreTRM® test measures and analyzes proteins in the blood that are highly predictive of preterm birth. The PreTRM® test permits physicians to identify, during the 19th or 20th week of pregnancy, which women are at increased risk for preterm birth, enabling more informed, personalized clinical decisions based on each woman’s individual risk. The PreTRM® test is ordered by a medical professional.
Sera Prognostics, the Sera Prognostics logo, The Pregnancy Company, and PreTRM are trademarks or registered trademarks of Sera Prognostics, Inc. in the United States and/or other countries.
Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to progress on the company’s pipeline; and the company’s strategic directives under the caption “About Sera Prognostics, Inc.” These “forward-looking statements” are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: net losses, cash generation, and the potential need to raise more capital; revenues from the PreTRM test representing substantially all Company revenues to date; the need for broad scientific and market acceptance of the PreTRM test; a concentrated number of material customers; our ability to introduce new products; potential competition; our proprietary biobank; critical suppliers; the ongoing COVID-19 pandemic and its impact on our operations, as well as the business or operations of third parties with whom we conduct business; estimates of total addressable market opportunity and forecasts of market growth; potential third-party payer coverage and reimbursement; new reimbursement methodologies applicable to the PreTRM test, including new CPT codes and payment rates for those codes; changes in FDA regulation of laboratory-developed tests; the intellectual property rights protecting our tests and market position; and other factors discussed under the heading “Risk Factors” contained in our Final Prospectus on Form S-1, which was filed with the Securities and Exchange Commission on July 14, 2021, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q, Annual Reports on Form 10-K, or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.
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