Sera Prognostics is a women's health diagnostics company with a single commercial product: the PreTRM test, a blood-based biomarker test that predicts a pregnant woman's individualized risk of spontaneous preterm birth. Administered between weeks 18 and 20 of gestation, the test measures the ratio of two proteins in maternal blood — IBP4 and SHBG — combined with the patient's height and weight. A blood sample is drawn once, analyzed via mass spectrometry at Sera's CLIA-certified lab in Salt Lake City, and results are returned to the ordering clinician as a risk report. Women identified as high-risk are then placed on an intervention bundle — including vaginal progesterone, low-dose aspirin, and cervical monitoring — designed to reduce preterm delivery and neonatal complications. Sera sells primarily to OB/GYNs and maternal-fetal medicine specialists. The company charges per test, priced at $750 under the CMS Clinical Laboratory Fee Schedule, though the primary commercial targets are private insurers, Medicaid programs, and self-insured employers. The business is pre-scale, with revenue in the early stages of commercialization. Growth depends on securing payer coverage state by state, driving physician adoption in covered geographies, and eventually achieving inclusion in ACOG/SMFM clinical guidelines — which Sera estimates could occur in 2027–2028. Beyond PreTRM, Sera has a pipeline of biomarker tests in development for preeclampsia, gestational diabetes, and other pregnancy complications.
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