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 is also collaborating with healthcare providers in the U.S. 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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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 is generalizable across the U.S. population from 11 sites in multiple geographic locations with 5,501 patients, and are 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 PAPR study in which the biomarkers were discovered.
  • Published as Editor’s Choice article in American Journal of Obstetrics & Gynecology (August 2020)
  • Data generated across the U.S. population from 18 sites in multiple geographic locations with 5,011 patients

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Publications and papers supporting the PreTRM Test

“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

We believe providing an individualized risk of spontaneous premature birth and other pregnancy complications is a critical first step to improving maternal and newborn health. Healthcare providers and healthcare payers also need the confidence to deliver better outcomes for their patients. Sera is dedicated to quantifying the benefit of using standard medical interventions to proactively treat mothers found to be at higher risk for prematurity by the PreTRM Test.

Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcomes (PRIME)

Currently Recruiting

  • 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 19th or 20th week of singleton pregnancies.

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Read publications and papers supporting the PreTRM Test.

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