What is the PreTRM® Test?
The PreTRM® Test is a clinically validated maternal blood biomarker test that identifies pregnancies at higher or not higher risk for spontaneous preterm birth in asymptomatic, singleton pregnancies for women ages 18+.
Most spontaneous preterm births occur in patients with no known risk factors.3 The PreTRM® Test helps providers identify that risk early, allowing for proactive care.
The test requires a single blood sample collected between 180/7 and 206/7 weeks of gestation during the second trimester of pregnancy (126–146 days) paired with personal history questions about a mom’s prior pregnancies and clinical factors.
The PreTRM® Test stratifies a patient’s risk of spontaneous preterm birth relative to the general obstetric population, enabling proactive care planning and discussion of preventive interventions.
The test is appropriate for pregnant women with singleton pregnancies who show no signs or symptoms of preterm labor.¹
Orders must be placed by a licensed healthcare provider, such as an OB-GYN or maternal-fetal medicine specialist. You can submit orders online for faster report delivery and patient support or use a paper requisition form.
Online orders: Reports are available via the portal. An email notification is sent when the report is ready.
Paper orders: Reports are faxed to your practice.
Not Higher Risk results help clinicians confirm which patients are unlikely to be at increased risk of preterm birth, enabling reassurance and appropriate allocation of care resources.
Higher Risk results enable clinicians to initiate earlier monitoring, preventive interventions, and personalized prenatal care. Multiple studies, including the PRIME randomized controlled trial, have shown improved neonatal outcomes when patients know their risk, including reduced time in the hospital and increased gestational age in the earliest births for high-risk pregnancies receiving preventive interventions.1,2
Cost shouldn’t get in the way of critical health information for mothers and their babies.
The out-of-pocket cost for the PreTRM® Test depends on a number of factors, including your patients’ insurance coverage, benefits, and deductibles. Sera offers financial support options such as an interest-free payment plan, a prompt pay discount, and a financial assistance plan that may be available to your patients. With or without insurance, our dedicated Customer Support Team is here to help. Please call (801) 990-6600 and select “Option 1” to speak to our Customer Support Team about financial options.
The current list price of the PreTRM® Test is $750.
The American Medical Association (AMA) assigned a dedicated CPT® Proprietary Laboratory Analyses (PLA) code, 0247U, effective April 1, 2021, to facilitate billing and payment for the PreTRM® Test.
The PreTRM® Test measures clinically validated biomarkers in maternal serum via chromatographic separation and multiplex mass spectrometry. An algorithm combines biomarker levels with clinical data to assess preterm birth risk.
Yes. Sera Prognostics’ laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA). CLIA ID: 46D2064326.
Yes. The laboratory is accredited by the College of American Pathologists (CAP). CAP Number: 8715460 | AU-ID: 1685065.
Yes. The laboratory is CAP- and CLIA-certified and approved by the New York State Department of Health, allowing nationwide availability.
Question not answered?
Are you unable to find what you are looking for? We are here for you. Send us an email at Support@pretrm.com or call us at 801-990-6600. We will get back to you promptly.
References
- Considerations for use: The PreTRM Test for Risk Management predicts the risk of spontaneous preterm birth (before 37 weeks) in asymptomatic women (no signs or symptoms of preterm labor with intact membranes) ≥18 years old with a singleton pregnancy. The PreTRM Test is performed via a single blood draw between 18wk – 20wk/6d (126 – 146 days) gestation. It is not intended for use in women who have a multiple pregnancy, have a known or suspected fetal anomaly, or are on any form of progesterone therapy after the first trimester. If the PreTRM Test was ordered for a patient outside of intended use for this test, caution should be exercised when interpreting the personalized risk results.
- Hoffman MK, Kitto C, Zhang Z, Shi J, Walker MG, Shahbaba B, Ruhstaller K. Neonatal Outcomes after Maternal Biomarker-Guided Preterm Birth Intervention: The AVERT PRETERM Trial. Diagnostics. 2024; 14(14):1462. https://doi.org/10.3390/diagnostics14141462
- Iams, JD. Clinical Practice. Prevention of preterm parturition. N Engl J Med. 2014;370:254-61.