Preterm birth represents a significant medical need that requires better risk identification to enable physicians to introduce established interventions to improve the health of women and their babies. The quality of the preterm risk predictions is a function of careful experimental design and assessing the performance against a complete intended use population for whom the test is designed to screen. Sera’s biomarker development work in TREETOP continues the rigorous and careful approach that enables Sera to provide doctors and patients important pivotal information to enhance clinical decision-making.
Sera will submit the findings to scientific review to take place during the fall of 2019.
The TREETOP study is a multicenter, prospective, real-time observational study to assess preterm birth risk. The study involves leading investigators in 18 clinical sites representing a diverse patient population across the U.S. Blood samples were prospectively collected from pregnant women between 17 and 22 weeks of gestation.
The TREETOP study design follows authoritative National Academy of Medicine guidelines (Evolution of Translational Omics: Lessons Learned and the Path Forward, 2012) for validating tests that combine multiple biomarkers into predictions suitable for clinical use. As in Sera’s first clinical study, the Proteomic Assessment of Preterm Risk study published in the American Journal of Obstetrics and Gynecology in May 2016, Sera followed rigorous guidelines that includes establishing test performance in all patients for which the test is intended and will be applied (i.e. the intended use population) and the use of multiple completely independent phases of analysis. Carefully following these guidelines improves product quality and ensures that test performance in the real-world will more closely mimic reported performance during development. TREETOP completes a final clinical validation step in the Academy’s guidance; that is to confirm performance a second prospective study utilizing patients entirely different than those studied previously.
About Preterm Birth
According to the March of Dimes, globally preterm birth affects 15 million infants each year, with 1 million deaths occurring from prematurity. Of nearly 4 million babies born annually in the U.S., approximately one in ten is born prematurely.1 Preterm birth is defined as any birth before 37 weeks gestation and is the leading cause of illness and death in newborns. 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, and vision and hearing loss, and can generate significant costs throughout the lives of affected children. Approximately $32B of expense occurs annual as a result of premature birth. 2
About the PreTRM® Test
The PreTRM® test is the only clinically-validated blood test that provides an early and 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 can help physicians identify early in the pregnancy (as early as 19 weeks of gestation) which women are at increased risk for premature delivery, enabling more informed clinical decisions based on each woman’s individual 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.
2 Caughey et al, Am J Perinatol Rep 2016;6:e407-e416