About
PreTRM® by Sera Prognostics is a clinically validated prenatal diagnostic test designed to identify which pregnancies are at elevated risk for preterm birth—before obvious symptoms or complications arise. Preterm birth (before 37 weeks) affects roughly 1 in 10 pregnancies in the U.S. and carries significant emotional, financial, and long-term health consequences for babies and families. Historically, many preterm births occurred with no visible warning signs, leaving providers with limited ability to intervene early. PreTRM closes that gap by measuring the levels of specific proteins (biomarkers) in a mother's blood during the second trimester (18–20 weeks). The test requires only a single finger-prick blood sample collected during a routine prenatal visit, making it minimally invasive and easy to integrate into standard obstetric care workflows. Results provide a personalized risk assessment that empowers obstetricians, midwives, and maternal-fetal medicine specialists to tailor monitoring, preventive interventions, and care plans for at-risk patients. The science behind PreTRM has been validated across multiple peer-reviewed clinical trials, most notably the large PRIME randomized controlled trial, which demonstrated consistent reductions in the earliest preterm births (before 32 weeks) and associated neonatal complications when results were used to guide care decisions. PreTRM is available through a provider portal, supporting ordering, draw-window calculation, and patient access programs. It is intended for use by licensed healthcare providers and is suitable for integration into maternal-fetal medicine practices, OB/GYN offices, and hospital-based prenatal care programs.
Key Features
- Biomarker-Based Risk Prediction: Measures specific protein levels in maternal blood to generate a personalized preterm birth risk score, providing objective data where none previously existed.
- Early Second-Trimester Testing: Performed at 18–20 weeks of pregnancy—well before the onset of preterm labor symptoms—giving providers and patients maximum time to implement preventive interventions.
- Non-Invasive Single Finger-Prick Sample: Requires only a small blood sample via finger prick during a routine prenatal visit, minimizing patient burden and simplifying clinical workflow integration.
- Clinically Validated by PRIME RCT: Backed by multiple peer-reviewed clinical trials, including the landmark PRIME randomized controlled trial, which demonstrated reduced rates of the earliest preterm births when PreTRM results guided care.
- Provider Portal & Ordering Tools: Healthcare providers access a dedicated portal to place orders, calculate optimal draw windows, and manage patient results, streamlining adoption into existing practices.
Use Cases
- OB/GYN practices using PreTRM results to identify at-risk patients early and personalize monitoring frequency, progesterone therapy, or referral to maternal-fetal medicine specialists.
- Maternal-fetal medicine programs integrating PreTRM into high-risk obstetric protocols to stratify patients by preterm birth probability and allocate specialist resources accordingly.
- Hospital systems and health networks seeking to reduce NICU admissions and neonatal morbidity by enabling evidence-based preventive interventions earlier in pregnancy.
- Expectant mothers with no obvious risk factors using PreTRM to gain peace of mind or proactively discuss individualized care plans with their providers based on objective biomarker data.
- Clinical researchers and public health organizations leveraging PreTRM data to study preterm birth epidemiology, evaluate intervention efficacy, and develop next-generation maternal health protocols.
Pros
- Actionable Early Insight: Identifies at-risk pregnancies at 18–20 weeks, providing a wide window for clinical intervention before preterm labor develops.
- Strong Clinical Evidence: The PRIME randomized controlled trial and additional studies provide robust validation, giving providers confidence in the test's predictive value.
- Minimal Patient Burden: A single finger-prick sample collected during an already-scheduled prenatal visit means no extra procedures, needles, or clinic visits for patients.
- Personalized Care Enablement: Transforms a one-size-fits-all prenatal protocol into individualized care plans, potentially reducing NICU admissions and improving neonatal outcomes.
Cons
- Provider-Only Access: The test must be ordered through a licensed healthcare provider; patients cannot self-order, which may limit access in underserved areas with limited prenatal care.
- Insurance Coverage Variability: Reimbursement and insurance coverage may not be universal, potentially creating out-of-pocket costs for some patients depending on their health plan.
- Narrow Testing Window: The test is optimally performed at 18–20 weeks, so patients who present late to prenatal care or miss the draw window cannot benefit from early risk stratification.
Frequently Asked Questions
What is the PreTRM® test and how does it work?
PreTRM® is a prenatal blood test that measures specific protein biomarkers in a mother's blood sample. By analyzing these protein levels, the test calculates a personalized risk score indicating the likelihood that the pregnancy will result in a preterm birth (before 37 weeks).
When during pregnancy is the PreTRM test performed?
The test is performed between 18 and 20 weeks of pregnancy, during a routine prenatal visit. This second-trimester window was selected to provide maximum lead time for clinical action while biomarker signals are most predictive.
Who can order the PreTRM test?
PreTRM must be ordered by a licensed healthcare provider, such as an OB/GYN, midwife, or maternal-fetal medicine specialist. Providers can register through the PreTRM provider portal to access ordering, draw-window tools, and patient resources.
What clinical evidence supports PreTRM?
PreTRM has been studied in multiple clinical trials. The PRIME study—a large randomized controlled trial—is the landmark evidence, demonstrating that using PreTRM results to guide prenatal care consistently reduced the incidence of the earliest preterm births and associated newborn complications.
Is the PreTRM test safe for mother and baby?
Yes. PreTRM is non-invasive and requires only a small blood sample collected via a finger prick. There are no known risks to the mother or fetus from the sample collection process, and it is designed to be performed alongside routine prenatal care without additional clinic visits.
