Intermountain Health and Christiana Care Health System Begin Enrollment on Two Landmark Preterm Birth Studies with PreTRM® Test
— PREVENT PRETERM AND AVERT PRETERM TRIAL will assess impact of interventions based on early risk identification to prolong pregnancy and reduce the rate of preterm birth–
Salt Lake City, July 1, 2018 – Sera Prognostics®, The Pregnancy Company™, announces the recent launch of two new preterm birth studies using the PreTRM® test to identify high-risk mothers for intervention care. These studies are being run by Intermountain Healthcare in Utah and Christiana Care Health System in Delaware. Both intervention studies will use Sera’s PreTRM® test to identify women at high risk of early delivery that will receive proactive interventions with the goal of reducing the rate of premature delivery and improving newborn health.
In May, Intermountain Healthcare launched PREVENT PTB, a first of its kind study involving up to 10,000 women that will use the PreTRM® test to identify those at risk for premature birth, and, in those with high risk, to evaluate the impact of early interventions designed to prolong their pregnancy and reduce the rate of premature delivery. D. Ware Branch, MD, medical director of Intermountain Healthcare’s Women and Newborns Clinical Program, is principal investigator of the study. For more information on the PREVENT PTB study, please visit: HealthClinicalTrials.gov Identifier: NCT03530332.
In June, Christiana Care Health System launched the AVERT PRETERM TRIAL. This study will enroll nearly 3,000 women, comparing a test/treat arm, where high-PreTRM® risk patients receive intensive interventions, to a historical control arm whose patients did not receive PreTRM® testing, but received usual standard of care treatment. The principal investigator for the study is Matthew Hoffman, M.D., MPH, FACOG, Marie E. Pinizzotto, M.D., Endowed Chair of Obstetrics and Gynecology at Christiana Care Health System in Wilmington, Delaware. For more information on the AVERT study, please visit:
HealthClinicalTrials.gov Identifier: NCT03151330.
“We are pleased to support these two outstanding organizations as they advance clinical research to show the benefits of early identification and proactive intervention in reducing preterm birth rates and improving the health of babies,” said Gregory C. Critchfield, MD, MS, chair and CEO of Sera Prognostics. “By identifying more pregnancies where earlier, more proactive intervention is beneficial, society, families and, most importantly newborn infants, have the potential for better outcomes and lower healthcare costs.”
These two intervention studies will create data to support future insurance coverage and physician adoption for Sera’s PreTRM® test.
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 improve the economics of healthcare delivery for pregnant women. Sera is developing innovative diagnostic tests focused on the early prediction of preterm birth (PTB) 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 that is used early in pregnancy to accurately predict 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 backed by highly respected healthcare investors, including Domain Associates, InterWest Partners, Catalyst Health Ventures, the Bill & Melinda Gates Foundation, and LabCorp. Sera is collaborating with the Gates Foundation to translate its discoveries into technologies well suited for low and middle-income countries in its journey to improve maternal and infant health globally. Two prospective intervention studies are underway to demonstrate the impact of proactive treatment to reduce the rate of preterm birth when women are identified at high risk of prematurity with the PreTRM test. Sera Prognostics is located in Salt Lake City, Utah. For more information, please visit the company’s website at www.seraprognostics.com.