Sera Prognostics Navigates Medicaid Landscape, Pursues Reimbursement for Preterm Birth Test

NEW YORK, NY – November 13, 2025

Securing a Foothold in a Competitive Market

Sera Prognostics reported mixed financial results for the third quarter of 2025, with revenue declining to $16,000 compared to $29,000 year-over-year. However, the company continues to advance its commercialization strategy for PreTRM, a blood test designed to identify women at risk of preterm birth. A key focus remains securing reimbursement and broader access through pilot programs, particularly within the Medicaid system. While the revenue shortfall raises concerns, a strong cash position of $102.4 million provides runway through 2028, allowing the company to pursue its long-term growth strategy.

The company is actively engaging with Medicaid programs covering a significant portion of the U.S. birth population – approximately 33% of all births and 35% of Medicaid births. A pilot program with Nevada Medicaid has already begun, contributing $100,000 in deferred revenue, and the company is hopeful that positive results from this initiative will pave the way for broader adoption. “The Medicaid landscape is complex, but represents a significant opportunity to reach a large number of women who could benefit from PreTRM,” noted one industry observer. “Demonstrating cost-effectiveness and improved outcomes is crucial.”

The Reimbursement Roadmap: Navigating Medicaid & Demonstrating Value

The path to securing reimbursement for innovative diagnostic tests is rarely straightforward, and the Medicaid system presents unique challenges. Sera Prognostics is focusing on demonstrating the economic benefits of PreTRM, highlighting its potential to reduce costly neonatal intensive care unit (NICU) stays. By identifying high-risk pregnancies early, clinicians can implement targeted interventions that may prevent preterm birth or mitigate its complications. “The key is to show that the test pays for itself by reducing overall healthcare costs,” explained a health economics consultant. “Payers are increasingly focused on value-based care, and PreTRM has the potential to deliver significant value.”

The company’s PRIME study data, presented at recent medical conferences, suggests that PreTRM can lead to an 18% reduction in severe neonatal morbidity and mortality, as well as a reduction in NICU admissions. While full publication of the PRIME study is expected, initial findings have generated positive feedback from healthcare professionals and payers. Nevada’s shift towards statewide managed care, coinciding with the pilot program, could further bolster the test’s integration within the healthcare system.

PreTRM in a Crowded Field: Competition & Innovation in Preterm Birth Risk Assessment

The market for preterm birth risk assessment is becoming increasingly competitive, with a range of diagnostic tests and technologies vying for adoption. While ultrasound remains a widely used tool, biomarker-based tests like PreTRM are gaining traction, offering the potential for earlier and more accurate risk assessment. Several competing tests exist, including fetal fibronectin (fFN) tests, PartoSure, and Actim Partus. However, PreTRM distinguishes itself as a predictive blood test that can identify risk even in women without evident risk factors.

The growing demand for more precise and personalized prenatal care is driving innovation in this field. Companies are exploring new biomarkers, advanced analytics, and artificial intelligence (AI) to improve the accuracy and predictive power of their tests. The projected growth of the preterm birth and premature rupture of membranes (PROM) testing market, expected to reach USD 2.94 billion by 2032, underscores the increasing importance of early risk assessment and intervention.

Building a Strong Team & Future Outlook

To support its commercialization efforts, Sera Prognostics has recently appointed Dr. Tiffany Inglis as Chief Medical Officer and Marisol Urbano as Head of Commercial Operations. Dr. Inglis brings extensive clinical experience and a deep understanding of women's and children's health, while Urbano will focus on strengthening the company’s commercial infrastructure and expanding its reach. These leadership appointments signal a commitment to building a strong team and driving the adoption of PreTRM.

The company’s long-term success will depend on its ability to navigate the complex reimbursement landscape, demonstrate the clinical and economic value of PreTRM, and effectively compete in a crowded market. While challenges remain, Sera Prognostics’ strong cash position, positive clinical data, and strategic focus on Medicaid represent a solid foundation for future growth. The potential to improve maternal and neonatal health outcomes through earlier and more accurate risk assessment remains a powerful motivator for the company and its stakeholders.