Sera Prognostics, Inc. (NASDAQ: SERA)

Sera Prognostics, Inc. is a women’s health company that uses a proprietary proteomics and bioinformatics platform to develop blood based biomarker tests and predictive analytics for maternal and neonatal health. The company concentrates on predicting preterm birth with its commercial product the PreTRM test which gives a personalized risk score for spontaneous delivery before 37 weeks gestation. Sera Prognostics also maintains a pipeline of biomarker candidates for conditions such as preeclampsia, gestational diabetes and fetal growth restriction. Its vision is to become the global leader in high value women’s diagnostics by providing actionable information to pregnant women their physicians and health care payers. The company notes that there are about 140 million births worldwide each year and approximately 3.7 million births in the United States and that up to 30% of pregnancies experience complications that could benefit from early risk detection.

Sera Prognostics generates revenue primarily from the sale of the PreTRM test to health care providers and through reimbursement agreements with health insurers. Under its commercial collaboration with Elevance Health the company receives payment for each test administered to eligible members of that insurer’s plan. The Centers for Medicare and Medicaid Services has assigned a unique CPT PLA code to the PreTRM test and priced it at six hundred fifty dollars which serves as a reference for private payer reimbursement. Additional revenue may come from licensing the underlying biomarker technology offering related analytical services and future sales of pipeline products once they obtain regulatory clearance. The company also pursues value based contracts with employers and health systems that tie payment to improvements in neonatal outcomes and cost reductions.

Sera Prognostics holds a leading position in the preterm birth risk assessment market as the only company with a broadly validated commercially available blood test that predicts spontaneous preterm birth. Its competitive advantage comes from a proprietary biobank that contains samples from thousands of pregnant women across diverse geographic and demographic groups. The platform uses advanced mass spectrometry and sophisticated bioinformatics to discover and validate protein biomarkers that have been reproduced in independent cohorts from the United States Europe Asia and Africa. While other companies operate in the prenatal testing arena none have published prospective trial data linking a biomarker test to measurable reductions in neonatal intensive care unit stays and associated costs. This first to market status combined with rigorous scientific validation gives Sera Prognostics a distinct edge over potential future competitors.

The company serves pregnant women obstetricians maternal fetal medicine specialists health care systems and health insurers. A specific customer is Elevance Health which incorporates the PreTRM test into its insurance plans and uses it to guide prenatal care for its members. Broadly the customer base includes providers seeking reliable risk stratification tools to identify pregnancies that may benefit from early intervention and insurers aiming to lower neonatal morbidity and reduce expenses related to preterm birth. Sera Prognostics also explores direct to consumer channels and partnerships with employers to expand access to its testing services.