Sera Prognostics Completes Enrollment of Large, Multicenter, Prospective Clinical Study of PreTRM® Test
– TREETOP Study will Explore Enhancements to Sera’s Validated PreTRM® Test –
Salt Lake City, Nov. 27, 2018 — Sera Prognostics, Inc., a women’s health company, announced today that it has completed enrollment of 5,009 women into its prospective real-time study, “A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor (TREETOP).” TREETOP enrollment was conducted in 17 centers across the US. The study is designed to prospectively evaluate Sera’s clinically validated PreTRM® test under real-time clinical testing conditions. In addition, data from TREETOP will enable Sera to explore enhancements that will provide additional important insights about a woman’s pregnancy that could better inform expectant mothers and their physicians when making clinical and lifestyle decisions.
Preterm birth affects approximately 1 in 10 pregnancies in the US1 and can result in both short- and long-term complications. The annual costs in the US healthcare system of managing prematurity and its complications were estimated at $31.5B2 in 2015.
“Patients matter: mother, child and family. Sera is committed to what is best for patients by applying rigor and care in developing and validating its tests for clinical use,” said Gregory C. Critchfield, M.D., M. S., chairman and chief executive officer of Sera Prognostics. “We thank our excellent collaborators at each of the TREETOP sites for their dedication in joining with us to advance this research. The data from this study will further support achieving Sera’s vision: to improve the health and well-being of mothers and newborns world-wide.”
The final results of the TREETOP trial are expected to be completed during 2019, as deliveries occur from the patients now enrolled in the study. For more information, please visit (https://clinicaltrials.gov/ct2/show/NCT02787213).
The TREETOP study is a multicenter, prospective, real-time observational study to assess spontaneous preterm birth risk. The study involves leading investigators in 17 clinical sites that represent the broad diversity of patients 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. The proper validation of such tests starts with a careful definition of intended use patients (the clinical characteristics of which must well-defined and known prior to applying such a test). Discovery, verification (confirmation) and validation activities take place on three separate (independent) specimen sets of such patients. Carefully following these guidelines improves the quality and defines the applicability of these tests – essentially eliminating the risk that the performance of a test is due to chance and not representative of what would occur in actual clinical practice. A final desirable step in the Academy’s guidance is to validate prospectively the performance of a test in a set of patients entirely different than those studied previously.
The results from TREETOP are intended to help physicians and women to make better informed decisions by identifying patients at risk for adverse outcomes, and by more deeply characterizing the course of pregnancy, enabling more proactive management than is currently possible.
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.1Preterm 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.
About the PreTRM® Test
The PreTRM® test is the first and only broadly 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.
About Sera Prognostics, Inc.
Sera Prognostics is a global leader in high-value women’s health diagnostics, delivering pivotal information to physicians to improve health and to improve the economics of healthcare delivery for pregnant women. Sera is developing innovative diagnostic tests focused on the early prediction of preterm birth risk and other complications of pregnancy. Sera’s PreTRM® test is available nationwide through the Company’s collaboration with LabCorp. PreTRM is the first and only broadly clinically-validated blood test to accurately predict early in pregnancy the risk of premature birth. The test objectively reports to the physician the risk of premature delivery, enabling earlier proactive interventions designed to prolong gestation and improve neonatal health outcomes. Sera’s strong management team has significant clinical development and women’s healthcare diagnostic experience. Sera is working with the Gates Foundation to translate the Company’s discoveries into technologies well suited for low-income countries in its journey to improve maternal and infant health globally. Sera Prognostics is located in Salt Lake City, Utah. For more information, please visit the company’s website at www.seraprognostics.com.
2 Caughey et al, Am J Perinatol Rep 2016;6:e407-e416