Project focused on reducing maternal and neonatal mortality and morbidity by mitigating the risks associated with unplanned preterm births
SALT LAKE CITY, May 5, 2022 /PRNewswire/ — Sera Prognostics Inc., The Pregnancy Company® (NASDAQ: SERA), is focused on improving maternal and newborn health by providing innovative pregnancy biomarker information to physicians and patients, and the Newborn Foundation today announced the launch of the Every mother, every baby Project.
the Every mother, every baby The project, developed by the Newborn Foundation in partnership with Sera, is designed to educate clinical practitioners, policy makers and public health actors on the critical role that preterm risk assessment tests based on validated biomarkers like the Sera’s PreTRM® test may play in improving neonatal and maternal health outcomes. The Newborn Foundation will work collaboratively with industry and public health stakeholders to advance the educational, policy and implementation framework around early recognition of the risks associated with preterm birth as a means to improve equity health and achieve the United Nations Sustainable Development Goals.
This announcement follows a two-day forum where the Newborn Foundation brought together maternal and newborn health stakeholders to define national and global health policy priorities for 2022.
“Neonatal mortality is the leading cause of preventable infant death worldwide. More than 60% of infant deaths occur during the neonatal period and 35% of all newborn deaths are due to premature birth,” said Annamarie Saarinen, CEO of Newborn Foundation. “Biomarker tests that identify women at risk of preterm birth and enable risk reduction interventions are critical to reducing neonatal mortality and improving outcomes. Every mother, every baby The project will help answer the key questions needed to ensure wide and affordable access to these tests, regardless of the geographical or socio-economic status of the pregnant woman. We are excited to partner with Sera and other global health players to achieve this important goal. »
the Every mother, every baby The project is designed to achieve three key objectives:
- Reduce maternal and neonatal mortality by mitigating the risks associated with unplanned preterm births.
- Deploy an effective, efficient, and scalable provider and public health education program focused on the role of biomarker testing in assessing the risk of preterm birth.
- Provide the data needed to support government and public health policies and funding initiatives to ensure equitable access and appropriate reimbursement for standardized prenatal biomarker testing.
“The Newborn Foundation is a recognized leader in its work to improve the health of newborns and infants, both in United States and around the world. We are delighted to partner with an organization that shares our belief in the power of validated biomarker-based approaches to better assess the risk of preterm birth proactively, months before its onset, and to mitigate its harmful consequences,” said declared Gregory C. Critchfield, MD, MS, President and CEO of Sera Prognostics. “We look forward to working productively with the Foundation and other key stakeholders in important efforts to reduce health disparities and better address the global challenges of neonatal morbidity and mortality.”
The PreTRM® test was developed and extensively validated in the United States to predict spontaneous preterm birth (sPTB) in the Proteomic Assessment of Preterm Risk (PAPR) study. Recently, published data from the multinational AMANHI study on pregnancies in South Asia and sub-Saharan Africa demonstrate that Sera biomarkers can stratify spontaneous preterm birth in populations outside of United States. Additional work on biomarkers demonstrates their ability to predict very early preterm birth from all causes, gestational age at birth, length of neonatal hospital stay, and neonatal morbidity and mortality; in a large American prospective study, the TREETOP study (Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor). Additionally, the clinical utility and economic utility of Sera’s biomarker approach have been the subject of several published studies.
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 provide physicians with crucial, early pregnancy information, enabling them to improve the health of their patients and reduce the costs of providing healthcare. Sera has a strong portfolio of innovative diagnostic tests focused on early prediction of the risk of preterm birth and other pregnancy complications. Sera’s PreTRM® precision medicine test reports to a physician the individualized risk of spontaneous preterm birth during a pregnancy, enabling earlier proactive interventions in women at higher risk. Sera Prognostics is located at Salt Lake City, UT.
About the Newborn Foundation
The Newborn Foundation focuses on the early identification of health problems and equitable access to care through education, advocacy, research and public health initiatives. Since its inception in 2010, we have championed a streamlined, multi-stakeholder approach to ensure safe and effective innovations reach babies, families and clinicians.
About premature birth
Premature birth is defined as any birth before 37 weeks of gestation and is the leading cause of illness and death in newborns. The 2021 March of Dimes report card shows that of the approximately 3.6 million babies born each year in United States, more than one in ten is born prematurely. Prematurity is associated with a significantly increased risk of major long-term medical complications, including learning disabilities, cerebral palsy, chronic respiratory disease, intellectual disability, seizures, and loss of vision and hearing, and can generate significant costs throughout the life of affected children. Annual health care costs to manage short-term and long-term complications of prematurity United States were estimated at approximately $25 billion for 2016.
The PreTRM® test is the only extensively clinically validated and commercially available blood biomarker test that provides an early, accurate and individualized prediction of the risk of spontaneous preterm birth in asymptomatic singleton pregnancies. The PreTRM® test measures and analyzes proteins in the blood that are highly predictive of premature birth. The PreTRM® test allows physicians to identify, during the 19th or 20th week of pregnancy, which women are at increased risk of preterm birth, allowing for more informed and personalized clinical decisions based on individual risk. of every woman. The PreTRM® test is ordered by a healthcare 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 the Newborn Foundation’s work to advance the educational, policy and implementation framework to improve health equity and achieve commitments to the United States. United Nations Sustainable Development Goals; the Every mother, every baby Project helping to answer the key questions needed to ensure wide and affordable access to these tests, regardless of the geographical or socio-economic status of the pregnant woman; ensure equitable access and appropriate reimbursement for standardized prenatal biomarker tests; and corporate strategic guidelines under the heading “About Sera Prognostics, Inc.” These “forward-looking statements” are based on management’s current expectations regarding future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those stated or implied. understood by the forward-looking statements. These risks and uncertainties include, but are not limited to: net losses, cash generation and the potential need to raise further capital; revenue from the PreTRM test representing almost all of the Company’s revenue to date; the need for broad scientific and commercial acceptance of the PreTRM test; a concentrated number of large 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 businesses or operations of third parties with whom we do business; estimates of total addressable market opportunities and market growth forecasts; potential third-party payment coverage and reimbursement; new reimbursement methodologies applicable to the PreTRM test, including new CPT codes and payment rates for these codes; changes in FDA regulations on laboratory-developed tests; intellectual property rights protecting our testing and market position; and other factors discussed under “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 these 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 contained in this press release is as of the date of publication, and the Company assumes no obligation to update such information except as required by law.
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SOURCE Sera Prognostics, Inc.