SALT LAKE CITY, October 19, 2015 — Sera Prognostics, Inc., a women’s healthcare company, today announced a program for early limited commercial access to PreTRM™, a proteomic biomarker blood test designed to provide an early, objective, and individualized assessment of a woman’s risk of preterm birth. The test will be made available in limited locations in the U.S., beginning with selected clinical sites that participated in the Proteomic Assessment of Preterm Risk (PAPR) study.
“Sera is focused on fighting premature birth and helping reduce the enormous societal and economic consequences of prematurity,” said Gregory C. Critchfield, MD, MS, Chairman and CEO of Sera Prognostics. “The ability for physicians to predict which women are at risk, early enough to enable proactive interventions, is now possible through the use of Sera’s PreTRM™ test. We are excited to embark on this early phase with PreTRM™ becoming available to physicians and patients.”
All PreTRM™ testing will be conducted at Sera’s state-of-the-art CLIA-certified laboratory in response to orders from women’s health care professionals. Following the early access outreach to physicians in selected markets this fall, Sera is planning for a wider national PreTRM™ rollout in 2016.
For more information about PreTRM™, please visit www.seraprognostics.com.
About Preterm Birth
Globally preterm birth affects 15 million infants each year, with 1 million deaths occurring from prematurity.1 Of the 4 million babies born annually in the U.S., approximately one in nine, or approximately 11 percent, is born prematurely. Preterm birth is defined as any birth before 37 weeks gestation, and is the leading cause of illness and death in newborns. Preterm birth 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. The complications from preterm birth can also extend beyond the first year of life, and can generate significant costs throughout the lives of affected children.
About Sera Prognostics, Inc.
Sera Prognostics is a private biotechnology company developing innovative diagnostic tests designed for the early prediction of preterm birth risk and other pregnancy complications. Sera’s tests are designed to help better inform the care of a mother and her unborn child during pregnancy, and potentially lead to improved health. The company has assembled a strong management team and Board of Directors with significant clinical development and women’s healthcare diagnostic experience. Sera has conducted the Proteomic Assessment of Preterm Risk (PAPR) study, one of the world’s largest and broadest clinical trials to validate the performance of the Company’s PreTRM™ test. PAPR enrolled 5,501 patients from 11 centers across the United States, representing the diversity of the intended use population for asymptomatic singleton pregnancies. The Company is supported by a strong group of investors, including The Bill and Melinda Gates Foundation, Chione, Ltd, Domain Associates, InterWest Partners, Catalyst Health Ventures, UpStart Life Sciences Capital, and Osage University Partners. The Company is working with the Bill and Melinda Gates Foundation to translate its discoveries and develop technologies to benefit women and infants in underserved countries worldwide. Sera Prognostics is located in Salt Lake City, Utah. For more information, please visit the company’s website at www.seraprognostics.com.