PreTRM® Test Clinical Studies

The PreTRM Test was developed and validated using a best practices approach for proteomics. Published peer-reviewed studies confirm the clinical validity of this test in delivering an accurate and reliable assessment of preterm birth risk in singleton pregnancies.

Sera has also collaborated with U.S. healthcare providers to quantify the benefit of its PreTRM test-and-treat strategy, using well-established medical interventions to proactively treat mothers found to be at high risk for premature delivery through the PreTRM Test.

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Supported by several peer-reviewed publications and a landmark randomized controlled trial, the PreTRM Test meets the standard of evidence providers rely on to inform care. Explore our studies below.

Our Clinical Studies & Publications

Clinical Studies

Analytical Validation
Clinical Validation
Clinical Utility
Economic Utility

  • Biomarker Screen-Guided Care for Preterm
    Birth Risk in Nulliparous Pregnancies:
    A Subgroup Analysis of the PRIME Randomized
    Controlled Trial 1

     Sciscione et al., 2026

    Evaluated the impact of PreTRM Test screen-guided care on neonatal outcomes in nulliparous (first-time) pregnancies within the PRIME randomized controlled trial. 

    Clinical Utility

  • Integrating Clinical Factors and Parity-Specific
    Models with Molecular Biomarkers to Better
    Predict the Risk of Preterm Birth in
    Asymptomatic Women 2

     Polpitiya et al., 2026

    Validated an enhanced PreTRM model that integrates maternal clinical risk factors with the proteomic ratio to improve prediction of spontaneous preterm birth.

    Clinical Validation
    Clinical Utility

  • PRIME3

     Iriye et al., 2026

    Further investigates the value of implementing the PreTRM test-and-treat strategy to reduce both adverse singleton pregnancy outcomes and overall healthcare costs

    Clinical Utility
    Economic Utility

  • AVERT4

     Hoffman et al., 2024

    PreTRM test-and-treat strategy demonstrates statistically and clinically significant improvement in neonatal health outcomes and hospital length-of-stay

    Clinical Utility

  • Prediction and Prevention of PTB5

     Combs et al., 2023

    Study concludes that screening with the PreTRM Test followed by care management intervention and LDA prolonged pregnancy and reduced adverse outcomes

    Clinical Utility

  • ACCORDANT CU (Treetop)6

     Burchard et al., 2022

    Combines real-world observational data with simulation to project significant potential improvements in neonatal outcomes among racially and ethnically diverse populations

    Clinical Utility
    Economic Utility

  • PREVENT7

     Branch et al., 2021

    Study demonstrates positive impact of the company’s PreTRM test and treat strategy on improving neonatal healthcare

    Clinical Utility

  • Cost-effectiveness of a Proteomic Test For Preterm Birth Prediction8

     Grabner et al., 2021

    Showed both improved neonatal outcomes and reduced immediate and long-term treatment costs associated with premature birth, when compared to routine care

    Clinical Utility
    Economic Utility

  • AJP Reports9

     Caughey et al., 2016

    Empirical data demonstrating the clinical and cost impact of prognostic test for early detection of preterm birth

    Clinical Utility
    Economic Utility

  • ACCORDANT Threshold10

     Burchard et al., 2021

    • Validated PreTRM threshold for clinical decision-making for risk of spontaneous preterm birth (sPTB) and adverse maternal and neonatal outcomes in cohorts with diverse racial and ethnic backgrounds

      Clinical Validation

  • PAPR11

     Saade et al., 2016

    AJOG editor’s choice establishing PreTRM clinical validation

    Clinical Validation

  • Clinical Mass Spectrometry12

     Bradford et al., 2017

    Achieved robust analytical validation of protein biomarkers for risk of spontaneous preterm birth

    Analytical Validation

“Through a systematic and rigorous approach to biomarker discovery we characterize the proteome of pregnancy. These significant discoveries pave the way toward a paradigm shift in obstetrical care in pregnancy and open the door to the identification of women at risk for aberrant conditions of pregnancy, such as preterm birth.”

Jay Boniface, Ph.D.
Chief Scientific Officer

Read More

Read publications and papers supporting the PreTRM Test.

References

  1. Sciscione AC, et al. Biomarker screen-guided care for preterm birth risk in nulliparous pregnancies: a subgroup analysis of the PRIME randomized controlled trial. J Matern Fetal Neonatal Med. 2026;39(1):2689850. doi: 10.1080/14767058.2026.2689850. Available at Taylor & Francis.tandfonline
  2. Polpitiya A, et al. Integrating Clinical Factors and Parity-Specific Models with Molecular Biomarkers to Better Predict the Risk of Preterm Birth in Asymptomatic Women. Diagnostics. 2026;16(10):1487. doi: 10.3390/diagnostics16101487. Available at MDPI.doi
  3. Iriye BK, et al. Neonatal impact of maternal biomarker screening for risk of preterm birth with targeted interventions (PRIME): A multicenter, randomized, controlled trial. Pregnancy. 2026;2(1):e70202. doi: 10.1002/pmf2.70202. Available at Wiley Online Library.
  4. 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. doi: 10.3390/diagnostics14141462
  5. C. Andrew Combs, John A.F. Zupancic, Mike Walker, Jing Shi. Prediction and Prevention of Preterm Birth: Secondary Analysis of a Randomized Intervention Trial. J Clin Med 2023;12(17). DOI: 10.3390/jcm12175459.
  6. Burchard, J., et al. Better Estimation of Spontaneous Preterm Birth Prediction Performance through Improved Gestational Age Dating. J. Clin. Med. 2022, 11, 2885. doi: 10.3390/jcm11102885
  7. Branch DW, et al. Prediction and Prevention of Preterm Birth: A Prospective, Randomized Intervention Trial. Am J Perinatol. 2021. doi: 10.1055/s-0041-1732339. Available at Thieme Connect.
  8. Grabner M, et al. Cost-Effectiveness of a Proteomic Test for Preterm Birth Prediction. Clinicoecon Outcomes Res. 2021 Sep 14;13:809-820. doi: 10.2147/CEOR.S325094. Available at Dove Medical Press.
  9. Caughey AB, Zupancic JA, Greenberg JM, Garfield SS, Thung SF, Iams JD. Clinical and Cost Impact Analysis of a Novel Prognostic Test for Early Detection of Preterm Birth. AJP Rep. 2016 Oct;6(4):e407-e416. doi: 10.1055/s-0036-1593866. PMID: 27917307; PMCID: PMC5133137.
  10. Burchard J, et al. Clinical Validation of a Proteomic Biomarker Threshold for Increased Risk of Spontaneous Preterm Birth and Associated Clinical Outcomes: A Replication Study. J. Clin. Med. 2021, 10, 5088. doi: 10.3390/jcm10215088. Available at MDPI.
  11. Saade GR, et al. Development and validation of a spontaneous preterm delivery predictor in asymptomatic women. Am J Obstet Gynecol. 2016;214:633.e1-24. doi: 10.1016/j.ajog.2016.02.001. Available at AJOG.
  12. Bradford C, Severinsen R, Pugmire T, Rasmussen M, Stoddard K, Uemura Y, et al. Analytical validation of protein biomarkers for risk of spontaneous preterm birth. Clinical Mass Spectrometry. 2017;3:25-38.