Sera Prognostics Appoints VP of Clinical Sciences

Sera Prognostics Inc., The Pregnancy Company, focused on improving maternal and neonatal health through innovative precision biomarker approaches, has appointed 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 the 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 & 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.

“Dr. Thomas Garite has tirelessly dedicated his professional energies to building impactful knowledge that has improved the practice of obstetrics,” said Gregory C. Critchfield, M.D., 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.”
 
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.
 
“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 percent in the U.S. 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.”
 
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 United States, more than one in 10 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 U.S. healthcare costs to manage complications of prematurity were estimated at $31.5 billion for 2015.²
 
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. 
 
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 U.S. 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: United States, Europe, Asia, and Africa, with over 10,500 patients tested in 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. 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.

References 
¹ http://www.marchofdimes.org/mission/prematurity-reportcard.aspx
² Caughey et al., Am J Perinatol Rep 2016;6:e407-e416