News
First and only broadly clinically validated test to provide accurate and actionable information to help reduce the morbidity, mortality, and costs associated with preterm birth
Salt Lake City and Phoenix – September 22, 2022 – 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, and Banner Health today announced that Sera’s PreTRM® Test will be available to Banner – University Family Care/ AHCCCS Complete Care (B – UFC/ACC) members. The PreTRM® Test is the only broadly clinically validated, commercially available blood test that provides an early, individual risk assessment for spontaneous preterm birth in asymptomatic, singleton pregnancies.
B – UFC/ACC is a Medicaid plan offered by Banner – University Health Plans, which is based in Tucson, AZ, and serves more than 300,000 members in ten Arizona counties.
“We are very pleased to work with Banner Health, which shares our commitment to reducing the adverse consequences of preterm birth. This organization is respected nationwide as an innovative leader in new healthcare models designed to optimize its members’ health while reducing the costs of care,” said Gregory C. Critchfield, MD, MS, Chairman and CEO of Sera Prognostics. “Preterm birth is associated with health complications that can affect babies at birth and also throughout the rest of their lives. Prematurity impacts not only mothers and the babies themselves but also their families, healthcare providers, payers, and communities. We developed the PreTRM® Test to help pregnant women and their physicians understand and take actions to mitigate elevated risks of premature birth, with the important goal of improving the health of mothers and babies and, in so doing, reducing health care system costs and burden.”
A rigorous health economic analysis published in ClinicoEconomics and Outcomes Research (https://www.dovepress.com/cost-effectiveness-of-a-proteomic-test-for-preterm-birth-prediction-peer-reviewed-fulltext-article-CEOR) in September 2021 shows that application of the PreTRM® strategy, consisting of testing and proactive, evidence-based interventions, improves neonatal outcomes and reduces immediate and long-term treatment costs associated with premature birth when compared to routine care.
“Value, not volume, is Banner’s driving factor, and our providers are rewarded for high-quality results and providing the latest in evidence-based preventive care,” said Robert Krauss, MD, Medical Director, Banner – University Health Plans. “A growing body of evidence supports the potential for the PreTRM® Test to improve fetal-maternal health outcomes and reduce the costs associated with premature birth. Making this cutting-edge predictive test available to our members advances our goal of improving the health of our member populations overall by providing individualized care that helps each member achieve the highest level of wellness. We are excited to integrate the PreTRM® Test into our fetal-maternal care protocols.”
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. In a subsequent large prospective U.S. study, the Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor (TREETOP), the biomarkers were further demonstrated to be predictive of very early preterm birth of any cause, length of neonatal hospital stay, and neonatal morbidity and mortality. Additional new data published in May 2022 showed improved PreTRM® Test predictive performance for women whose due dates are more reliably determined by ultrasound.
About Banner Health
Banner Health is one of the largest, secular nonprofit health care systems in the country. In addition to 30 acute-care hospitals, Banner also has an academic division, Banner – University Medicine, and a partnership with one of the world’s leading cancer programs, Banner MD Anderson Cancer Center. Banner’s array of services includes a health-insurance division, employed physician groups, outpatient surgery centers, urgent care locations, home care and hospice services, retail pharmacies, stand-alone imaging centers, physical therapy and rehabilitation, behavioral health services, a research division and a nursing registry. To make health care easier, 100% of Banner-employed doctors are available for virtual visits, and Banner operates a free 24/7 nurse line for health questions or concerns. Patients may also reserve spots at Banner Urgent Care locations and can book appointments online with many Banner-employed doctors. Headquartered in Arizona, Banner Health also has locations in California, Colorado, Nebraska, Nevada and Wyoming. For more information, visit bannerhealth.com.
About Banner – University Health Plans
Banner – University Health Plans (B – UHP) is a nonprofit, regional health plan dedicated to serving the health and insurance needs of the people of Arizona. For more than 20 years, B – UHP has provided access to best-in-class health care with unparalleled compassion and responsiveness to help members live healthy and well. B – UHP’s product portfolio includes Commercial, Medicaid and Medicare Special Needs Plans. B – UHP is the insurance division of Banner Health, one of the largest nonprofit health care systems in the country. B – UHP is based in Tucson, Arizona and serves more than 300,000 members in ten Arizona Counties. For more information, please visit www.BannerUHP.com.
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. www.seraprognostics.com
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, between the 18th and 20th weeks 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. www.pretrm.com
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 women not found to be at higher risk of preterm delivery by the PreTRM® Test having extremely high confidence of not delivering a premature infant; 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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