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.
Clinical Studies and Publications
The predictive accuracy of the protein biomarkers assessed by the PreTRM Test has been broadly clinically validated in two U.S. clinical studies in more than 10,500 patients.
Development and Validation of a Spontaneous Preterm Delivery Predictor in Asymptomatic Women- (PAPR)1
- Three independent studies (discovery, verification, validation) reported in a large multicenter trial
- Published as Editor’s Choice article in American Journal of Obstetrics & Gynecology (May 2016)
- Data were generalizable across the U.S. population from 11 sites in multiple geographic locations with 5,501 patients, becoming the basis of the commercial PreTRM Test.
Performance of a Proteomic Preterm Delivery Predictor in a Large Independent Prospective Cohort (TREETOP)2
- Confirmation and exploration of biomarker predictive performance for very early preterm deliveries in an independent cohort distinct from the study (PAPR) in which the biomarkers were discovered.
- Published as Editor’s Choice article in American Journal of Obstetrics & Gynecology (August 2020)
- Data were generated across the U.S. population from 18 sites in multiple geographic locations with 5,011 patients
Prediction and Prevention of Preterm Birth: A Prospective, Randomized Intervention Trial3
- Prospective, randomized controlled intervention trial evaluating clinical utility of applying the to screen pregnant women for risk of spontaneous preterm birth and treating women identified at higher risk with proactive interventions.
- Demonstrated a statistically significant reduction in median newborn intensive care unit (NICU) length-of-stay for spontaneous preterm deliveries admitted to the NICU – from 45.5 to 6.8 days (an 85% reduction).
- A total of 1191 pregnant women were randomized to undergo mid-trimester serum proteomics screening (n=595) or not (control group, n=596).
Clinical Validation of a Proteomic Biomarker Threshold for Increased Risk of Spontaneous Preterm Birth and Associated Clinical Outcomes: A Replication Study4
- Validation of a clinical decision point at spontaneous preterm birth risk of 15%, as determined by the PreTRM Test.
- Demonstrated that patients identified as higher risk by the PreTRM Test (above the 15% risk threshold) are at statistically significant higher risk for a spontaneous preterm birth, longer neonatal hospital length of stay, and severe adverse neonatal outcomes.
- Subpopulations of the PAPR and TREETOP studies were selected to conduct this prospective-retrospective cohort analysis.
Cost-Effectiveness of a Proteomic Test for Preterm Birth Prediction5
- Modeled the PreTRM test-and-treat strategy, consisting of testing and proactive evidence-based interventions, within claims data from a major payer with individual and employer-sponsored plans, and showed both improved neonatal outcomes and reduced immediate and long-term treatment costs associated with premature birth, when compared to routine care.
- Projected a $863 net savings ($1,608 gross savings) per pregnant woman, a $54 million reduction in total costs over the study population.
- The study analysis was conducted by Sera in partnership with HealthCore, using claims data of more than 40,000 pregnant women and infants who were members of individual and employer-sponsored health plans.
“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
Ongoing PreTRM® studies
Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcomes (PRIME)
- This randomized controlled trial aims to further investigate the value of implementing the PreTRM Test and treatment strategy to reduce both adverse singleton pregnancy outcomes and overall healthcare costs.
- The PRIME study is enrolling up to 6,500 women during the 18th through 20th week of singleton pregnancies.
Read publications and papers supporting the PreTRM Test.
- 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
- Markenson GR, et al. A proteomic preterm delivery predictor in a prospective cohort. Am J Obstet Gynecol MFM. 2020 Aug;2(3):100140. doi: 10.1016/j.ajogmf.2020.100140. Available at https://www.ajogmfm.org/article/S2589-9333(20)30084-7/fulltext
- 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
- 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
- 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