News

 – Sera's PreTRM® test-and-treat strategy helps build on Fors Marsh's commitment to investing in its employees to enable a healthy and viable workforce –

SALT LAKE CITY and ARLINGTON, Va., Nov. 29, 2022 /PRNewswire/ -- 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 Fors Marsh, a company dedicated to solving complex challenges through market research, are collaborating to provide Sera's PreTRM® Test to employees at Fors Marsh as part of their maternity benefits, effective January 1, 2023.

The PreTRM® Test is the only broadly clinically validated, commercially available blood-based test that provides an early, individual risk assessment for spontaneous preterm birth in asymptomatic, singleton pregnancies. Sera's PreTRM® Test identifies nearly 90% of pregnancies where spontaneous preterm deliveries will occur, enabling earlier proactive intervention designed to improve the well-being of mothers and babies.

Fors Marsh believes in driving innovation, fueled by empathy and grounded in evidence, to provide solutions that improve behavior and positively impact people and the planet. To this end, providing an innovative technology to help reduce preterm births within their population helps improve health outcomes and minimize high-risk maternity costs while bringing health equity to a diverse workforce, thus creating a stronger workplace of belonging.

"Putting people first is at the core of our business and we understand how investing in our people directly translates to better outcomes for them as well as our clients," said Fors Marsh People and Culture Director Christina Daugherty. "Preterm birth is a significant health complication that affects many families. We are encouraged by the PreTRM® Test's ability to help reduce the negative health and cost outcomes associated with preterm birth."

"By providing the PreTRM® Test to employees, Fors Marsh is illustrating its strong commitment to the well-being of women and their children," said Gregory C. Critchfield, MD, MS, Chairman and CEO of Sera Prognostics. "Beyond the important economic benefits that this new offering enables, Fors Marsh's commitment to its employees underscores how all companies can contribute to the long-term goal of improving maternal and infant health by helping arm physicians and patients with pivotal information to better inform care."

The PreTRM® Test was developed and validated for the 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 demonstrated to be predictive of very early preterm birth of any cause, length of neonatal hospital stay, and neonatal morbidity and mortality. 

Data published in May 2022 showed improved PreTRM® Test predictive performance for women whose due dates are more reliably determined by ultrasound. Additional new data were published in the Journal of Medical Economics in November 2022 in a secondary ACCORDANT health and economic model analysis conducted in a population of patients participating in the TREETOP study. The analysis found that the PreTRM® test-and-treat strategy in a diverse population predicts meaningful clinical and economic improvements in neonatal and maternal outcomes.

Fors Marsh takes on issues that matter -- a team of researchers, advisors, and communicators working together to shape the systems that shape our lives. From public health campaigns to policy analysis, Fors Marsh relies on evidence to create solutions that improve outcomes for people. Fors Marsh is intentional about taking on work and forming partnerships that balance purpose, people, planet, and profit.

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.

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.

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 enables physicians to identify, during the 18th or 20th week of pregnancy, which women are at increased risk for preterm birth, driving 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.

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to Fors Marsh's inclusion of the PreTRM® test in its employee maternity benefits package; 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.

Contact

Investor Contact
Peter DeNardo, CapComm Partners
peter@capcommpartners.com
+1 (415) 389-6400

Media Contact
Erich Sandoval, FINN Partners
Erich.sandoval@finnpartners.com
+1 (917) 497-2867

SOURCE Sera Prognostics, Inc.