Sera Prognostics Receives New York State Approval for PreTRM® Testing
Salt Lake City, Dec. 12, 2018 — Sera Prognostics, Inc., a women’s health company, announced today that the New York State Department of Health has issued a clinical laboratory permit for Sera to perform PreTRM® testing for pregnant women in the state of New York. The lab approval was based on the results of an on-site inspection and rigorous evaluation process. With this approval, Sera can now commercialize the PreTRM® test in New York, a very important health care market.
New York’s Clinical Laboratory Reference System (CLRS) provides guidelines, quality control standards and procedures to be used by permit-holding clinical facilities that provide laboratory services to healthcare providers in the state. In recognition of the fact that CLRS has requirements that are equal to or more stringent than the Clinical Laboratory Improvement Amendments of 1988 (CLIA), the program was granted exempt status by the federal Centers for Medicare and Medicaid Services (CMS) in 1995.
With New York State approval of Sera’s laboratory and PreTRM® test (https://www.wadsworth.org/regulatory/clep/approved-labs), Sera is permitted to provide its innovative laboratory testing services for intended use by pregnant women in all states nationwide.
“Sera is the only company to rigorously develop, validate, and receive state regulatory approval across the entire U.S. for its innovative PreTRM blood test. The PreTRM test objectively assesses the individual risk of premature birth by analyzing blood drawn early in pregnancy,” stated Greg C. Critchfield, M.D., M.S., chairman and chief executive officer of Sera Prognostics. “The approval by New York State is strong recognition of the quality and clinical utility of Sera’s PreTRM test. Sera is proud to be able to provide PreTRM’s important information to doctors and patients in New York State, to better inform earlier proactive decision-making.”
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.
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 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 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