June 24, 2020 –Salt Lake City Utah – Sera Prognostics, Inc., The Pregnancy Company™, focused on improving maternal and neonatal health through innovative precision biomarker approaches, today announced the appointment of Thomas J. Garite, M.D. as Vice President of Clinical Sciences. Dr. Garite will work closely with Sera to advance clinical development programs that support the company’s growth from development into a commercial-stage company.
Dr. Garite is a world-renowned and highly respected expert in Obstetrics and Gynecology and Maternal-Fetal Medicine and a recently retired Edward H. Quilligan Professor of Obstetrics and Gynecology at the University of California at Irvine. Dr. Garite served 18 years as this Department’s Chairman, and now holds the title of Professor Emeritus. He is also the past Editor in Chief of the American Journal of Obstetricians and Gynecology and remains Editor Emeritus. He has published more than 200 articles and chapters including over 150 original peer-reviewed journal articles and is the author or co-author of five textbooks. His research has focused on intrapartum and antepartum fetal assessment through fetal heart rate monitoring, prematurity in general, premature rupture of membranes, the infectious etiology of prematurity, and the management of labor.
Until recently, Dr. Garite served as Director of Research and Education for Obstetrix, MedNax Medical Group where he directed the only ongoing Collaborative Clinical Research group composed of a consortium of private practices and university Maternal-Fetal medicine groups. Under his leadership, his team published 25 collaborative studies including 10 multicenter collaborative research trials all in high impact obstetric journals during his 18-year tenure with the company. He also currently serves as Chief Clinical Officer for Perigen Inc, a national patient safety company.
“Dr. Thomas Garite has tirelessly dedicated his professional energies to building impactful knowledge that has improved the practice of obstetrics,” said Gregory C. Critchfield, MD., MS, Chairman, and CEO. “We are very fortunate to have Dr. Garite join the Sera team. He will provide critical leadership and support in advancing our clinical development efforts that are the basis of achieving Sera’s vision to improve the health of mothers and newborns and thereby improve the economics of health care delivery.”
“I am very pleased to take part in a vision that puts the well-being of mothers and newborns at the forefront, by conducting careful scientific and clinical research to address the challenges of prematurity and other conditions of pregnancy,” said Dr. Garite. “Preterm birth now exceeds 10% in the US and is a major cause of death and impairment of newborns. I look forward to providing my scientific experience and medical knowledge to help the company realize clinical and commercialization strategies that effectively address this serious healthcare crisis.”
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, and 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 expression changes 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. Subsequent scientific work has confirmed performance of Sera’s biomarker predictions in cohorts of patients across the globe: US, Europe, Asia and Africa, with over 10,500 patients tested in studies.
About Clinical Outcomes Data
Sera’s validated PreTRM® prediction has been taken into prospective intervention studies, where populations of pregnant women have been screened by the Sera test. Higher PreTRM®-risk pregnancies are stratified to receive earlier more proactive 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.
2 Caughey et al., Am J Perinatol Rep 2016;6:e407-e416