NEW YORK (360Dx) – The New York State Department of Health has issued a clinical laboratory permit for Sera Prognostics, enabling it to commercialize and perform testing with its PreTRM pre-term birth risk test for pregnant women in NY state.
The lab approval was based on the results of an on-site inspection and rigorous evaluation process, Sera said.
New York’s Clinical Laboratory Reference System 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. With NY State approval of Sera’s laboratory and test, the firm is permitted to provide testing services for intended use by pregnant women in all states nationwide.
The clinically validated test, ordered by a medical professional, measures the levels of two proteins in blood to predict a pregnant woman's risk of giving preterm birth. It provides an early and individual risk prediction for spontaneous preterm birth in asymptomatic, singleton pregnancies, the firm said. Physicians can identify by as early as 19 weeks of gestation whether a woman is at increased risk for premature delivery, enabling an informed clinical decision based on her individual risk.
Sera had launched the test in a limited release last year and made it available nationwide in 2017 through a collaboration with Laboratory Corporation of America.
Preterm birth affects approximately one in 10 pregnancies in the US and can result in both short- and long-term complications, said Sera, citing the 2018 Premature Birth Report Card published by the March of Dimes, an advocacy group for babies and their mothers.