News

Salt Lake City, Nov. 2, 2021 (PR NEWSWIRE) —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 a partnership with PreemieWorld, GLO Preemies, and the Alliance for Black NICU Families, leading organizations all geared to empowering and supporting families impacted by preterm birth.

“We are committed to help address the healthcare disparities that disproportionately affect underserved communities, particularly among African Americans,” said Gregory C. Critchfield, M.D., M.S., Chairman, and CEO of Sera Prognostics. “The long-term goal of this collaboration is to help educate and stimulate conversations between patients, their families, and their physicians to improve individualized assessment for preterm birth risk, as a way to enable earlier proactive pregnancy care and achieve better outcomes for mothers and newborns.”

According to a study published in 2020, African American women in the U.S. are 50% more likely to deliver prematurely when compared to Caucasian women.1 Identified factors include discrepancies in access to information about prenatal healthcare in general and preterm birth in particular. The pandemic has only compounded the issue—increased economic distress has resulted in even more reduced access to routine prenatal healthcare services.2,3

“African Americans are at a high risk for preterm birth, and this collaboration is designed to develop resources specifically targeted to help underserved populations,” said Ashley Randolph, founder of GLO Preemies and co-founder of the Alliance for Black NICU Families. “Of primary importance is getting information about prenatal healthcare and preterm birth to women who feel their concerns are not heard—and giving them a voice to advocate for themselves.”

The initial phase of the communications partnership includes distributing a children’s book entitled Will Our Egg Hatch Early? In an appendix following the story, the book focuses on risk factors for preterm birth, suggestions for initiating doctor-patient conversations around the subject, and information about support resources and the availability of Sera Prognostics’ PreTRM® test.

The PreTRM® test is the only broadly clinically validated, commercially available blood-based biomarker test that provides an early, accurate, and individualized risk prediction for spontaneous preterm birth in asymptomatic singleton pregnancies. Ordered by medical professionals, the test empowers physicians to better identify, during the 19th or 20th week of pregnancy, women who are at increased risk for premature delivery. This early knowledge enables these women and their doctors to develop personalized intervention plans to bring their pregnancies as close to full-term as possible.

Why is Sera Prognostics offering important health education in a children’s book? “Because a children’s book can go where nothing else can,” said Deb Discenza, CEO of PreemieWorld, an educational products and research company, and co-author of The Preemie Parent’s Survival Guide to the NICU. The books will be distributed initially to Black/African American families as part of care boxes and other already existing service offerings of organizations like those led by Randolph and Discenza. A Spanish-language version is also planned.

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 2020 March of Dimes Report Card shows that of approximately 3.8 million babies born annually in the 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 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, which is ordered by a medical professional, measures and analyzes proteins in the blood that are highly predictive of preterm birth.

Sera Prognostics, the Sera Prognostics logo, The Pregnancy Company, and PreTRM are trademarks or registered trademarks of Sera Prognostics, Inc in the U.S. 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 enabling earlier proactive pregnancy care and achieving better outcomes for mothers and newborns; distributing a children’s book entitled Will Our Egg Hatch Early?; 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.

References

1 Bryant, Allison S., et al. “Communicating with African-American Women Who Have Had a Preterm Birth about Risks for Future Preterm Births.” Journal of Racial and Ethnic Health Disparities, vol. 7, no. 4, 2020, pp. 671–677., https://doi.org/10.1007/s40615-020-00697-8.

2 Gur, Raquel E., et al. “The Disproportionate Burden of the Covid-19 Pandemic among Pregnant Black Women.” Psychiatry Research, vol. 293, 2020, p. 113475., https://doi.org/10.1016/j.psychres.2020.113475.

3 Onwuzurike, Chiamaka, et al. “Examining Inequities Associated with Changes in Obstetric and Gynecologic Care Delivery during the Coronavirus Disease 2019 (Covid-19) Pandemic.” Obstetrics & Gynecology, vol. 136, no. 1, 2020, pp. 37–41., https://doi.org/10.1097/aog.0000000000003933.

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