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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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Our Clinical Studies & Publications

Clinical Studies

Analytical Validation
Clinical Validation
Clinical Utility
Economic Utility

  • Clinical Mass Spectrometry1

     Bradford et al., 2017

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

    Analytical Validation

  • PAPR2

     Saade et al., 2016

    AJOG editor’s choice establishing PreTRM® clinical validation

    Clinical Validation

  • ACCORDANT Threshold3

     Burchard et al., 2021

    • alidated 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

  • AJP Reports4

     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

  • Cost-effectiveness of a Proteomic Test For Preterm Birth Prediction5

     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

  • PREVENT6

     Branch et al., 2021

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

    Clinical Utility

  • ACCORDANT CU (Treetop)7

     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

  • Prediction and Prevention of PTB8

     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

  • AVERT9

     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

  • PRIME10

     Iriye et al., ongoing

    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

“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

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Read publications and papers supporting the PreTRM Test.

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  1. 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.
  2. 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 https://www.ajog.org/article/S0002-9378(16)00284-2/fulltext
  3. 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 https://www.mdpi.com/2077-0383/10/21/5088
  4. 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.
  5. 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 https://www.dovepress.com/cost-effectiveness-of-a-proteomic-test-for-preterm-birth-prediction-peer-reviewed-fulltext-article-CEOR
  6. 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 https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0041-1732339
  7. Burchard, J., et al. Better Estimation of Spontaneous Preterm Birth Prediction Performance through Improved Gestational Age Dating. J. Clin. Med. 2022, 11, 2885. https://doi.org/10.3390/jcm11102885
  8. 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.
  9. 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
  10. Iriye et al., ongoing. https://clinicaltrials.gov/study/NCT04301518