Publication Demonstrates Ability of Sera Prognostics’ PreTRM® Biomarker Test as a Predictor of Adverse Pregnancy Outcomes

Sera Prognostics, Inc., The Pregnancy Company™ focused on improving maternal and neonatal health through innovative precision biomarker approaches, today announced the publication of positive data in a large, independent, contemporary prospective U.S. clinical cohort study, TREETOP (NCT02787213), in the American Journal of Obstetrics & Gynecology Maternal Fetal Medicine. The results of the study, which were selected for a podium presentation at the 40th Annual Pregnancy Meeting of the Society for Maternal-Fetal Medicine in February 2020, demonstrate that the company’s PreTRM^® biomarker test can be used to predict very preterm birth, (infants born before 32 weeks of gestation) as well as increased length of neonatal hospital stay and severe adverse neonatal outcomes.

Preterm birth is the second leading cause of infant mortality – a national healthcare crisis affecting more than 1 out of 10 pregnancies annually, a number currently on the rise, and the leading cause of infant mortality and morbidity. Previously, healthcare professionals were not equipped to proactively identify the great majority of women who go on to deliver a baby prematurely. The study authors conclude that the PreTRM^® test may serve as an important new tool for healthcare professionals and payers to identify at-risk women early in their pregnancies, enabling doctors to implement preterm birth preventive strategies and direct them to appropriate levels of care.

PreTRM is a serum-based proteomic test that uses the ratio of insulin-like growth factor-binding protein 4 (IBP4) to sex hormone-binding globulin (SHBG) to predict the risk of preterm birth. It is the only such clinically validated, commercially available blood test. The PreTRM^® test provides an early and individual risk prediction for preterm birth in asymptomatic, singleton pregnancies.

“The number one complication of pregnancy is preterm birth,” says Dr. Glenn Markenson, director of maternal and fetal medicine at Boston Medical Center and an author on the publication. “Despite a keen awareness of the negative consequences of preterm birth, the inability to adequately predict the majority of women are, in fact, at greatest risk for preterm birth has been a significant barrier to broadly implementing preventive interventions. The TREETOP results support the potential of using the IBP4 to SHBG ratio to predict the risk of preterm birth and subsequent adverse neonatal outcomes. The ability to predict this risk is critical for enabling precision care management.”

TREETOP (The Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor) is the first study powered to investigate the performance of PreTRM^® in predicting preterm births occurring before the 32^nd week of gestation (<32^0/7) and investigating negative outcomes associated with these births, such as length of neonatal hospital stay and neonatal morbidity and mortality. The multi-center study enrolled 5,011 women across 18 sites nationally, with a preplanned analysis performed on a randomly selected subgroup of 847 women. Key findings from the sub-study include:

• Of infants born to these 847 women, 21 had evidence of severe neonatal condition, up to and including death
• The IBP4/SHBG ratio was significantly higher in both very preterm births <32^0/7 weeks and more severe neonatal outcomes
  • The IBP4/SHBG ratio was significantly predictive of birth <32^0/7 weeks among all 847 women and when analyzed using a previously defined body mass index stratification (22 < BMI ≤37 kg/m²)
  • The IBP4/SHBG ratio predicted neonatal outcomes for composite morbidity/mortality scores of ≥3 or 4
  • The IBP4/SHBG ratio significantly identified women destined to deliver neonates with increased length of hospital stay

“Effective interventions that can delay or prevent preterm birth in a small fraction of patients carrying a single baby are well known within the maternal-fetal medicine community, but determining which additional women may benefit from these interventions requires validated prognostic tools,” said Gregory C. Critchfield, MD, MS, chairman and CEO of Sera Prognostics. “The TREETOP study results add to the growing body of data showing the clinical and scientific validity of Sera’s PreTRM^® biomarker test as a comprehensive objective method for understanding each woman’s individual risk of preterm birth. Knowledge of a woman’s individual risk can make a difference because it empowers physicians and every expectant mother to work more closely together to address a woman’s risk for early delivery.”

About Sera Prognostics, Inc.

Sera Prognostics is the leading health diagnostics company dedicated to improving the lives of women and babies through precision pregnancy care. Sera delivers pivotal information in early pregnancy to physicians, enabling them to improve the health of their patients, resulting in reductions in the costs of healthcare delivery. Sera has a robust pipeline of innovative diagnostic tests focused on the early prediction of preterm birth risk and other complications of pregnancy. Sera’s precision medicine PreTRM^® test reports to a physician the individualized risk of premature delivery in a pregnancy, enabling earlier proactive interventions in women with higher risk. Sera Prognostics is located in Salt Lake City, Utah. For more information, please visit the company’s website at www.seraprognostics.com.

About Preterm Birth

Preterm birth is defined as any birth before 37 weeks gestation and is the leading cause of illness and death in newborns. The 2019 March of Dimes Report Card shows that of nearly 4 million babies born annually in the U.S., more than one in ten is born prematurely.¹ Prematurity is associated with a significantly increased risk of major long-term medical complications, including learning disabilities, cerebral palsy, chronic respiratory illness, intellectual disability, seizures, vision and hearing loss, and can generate significant costs throughout the lives of affected children. The annual US health care costs to manage complications of prematurity were estimated at $31.5B for 2015.²

About the PreTRM® Test

The PreTRM^® test is the only clinically validated commercially available blood test that provides an early individual risk prediction for spontaneous preterm birth in asymptomatic, singleton pregnancies. The PreTRM^® test measures and analyzes proteins in the blood that are highly predictive of preterm birth. The PreTRM^® test permits physicians to identify, as early as 19 weeks of pregnancy, which women are at increased risk for premature delivery, enabling more informed clinical decisions based on each woman’s individual risk, so that her care can be personalized to address her risk. The PreTRM^® test is ordered by a medical professional. For more information about the PreTRM^® test, please visit www.PreTRM.com and the PreTRM^® test YouTube Channel. You can also join the conversation on Facebook and @PreTRM.

About Sera’s Science

Using its advanced mass spectrometry platform, Sera detects biologically important protein abundance differences to build high performing predictions of risk for adverse pregnancy outcomes (including preterm birth, preeclampsia, gestational diabetes, growth restriction, and others). Rigorous clinical validation of PreTRM^® test performance (accuracy of predicting premature delivery) was reported in the American Journal of Obstetrics & Gynecology in 2016 in a US cohort of 5,501 patients across 11 centers. Sera’s biomarker predictions have been studied with leading scientific collaborators in patient cohorts from the US, Europe, Asia and Africa.

About Clinical Outcomes Studies

Sera’s validated PreTRM^® prediction has been taken into prospective intervention studies, where populations of pregnant women have been screened by the Sera test. Women at higher PreTRM^® risk, not otherwise identifiable, receive interventions, and important outcomes are examined in comparison to pregnancies in control groups where the test is not available.

Topline results showing the benefit of the PreTRM^® strategy in a recently completed randomized controlled prospective intervention study (PREVENT PTB Study, NCT03530332) became available online for the Late Breaking Poster Session of the Annual Meeting of the Society of Reproductive Investigation, scheduled for March 14 in 2020 in Vancouver, Canada.

¹ http://www.marchofdimes.org/mission/prematurity-reportcard.aspx

² Caughey et al., Am J Perinatol Rep 2016;6:e407-e416

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