Sera Prognostics, Inc. Announces Publication of Data Demonstrating Improved Performance of its PreTRM Test with More Precise Gestational Age
May 19, 2022 at 06:27 pm EDT
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Sera Prognostics Inc. announced the publication of improved PreTRM test performance using women from the Proteomic Assessment of Preterm Risk (PAPR) clinical study whose pregnancy outcomes are aligned with updated ACOG gestational age dating guidelines. The newly published article reports: A greater observed sensitivity of 88% at 75% specificity, which represent increases of 17% and 1%, respectively, relative to all subjects; An improved performance was also demonstrated over an expanded 18-20 weeks' gestational age time interval for performing PreTRM testing, consistent with the timeframe of routine obstetric visits during pregnancy; A negative predictive value of 99% for the test, at its validated threshold.
Sera Prognostics, Inc. is a women's health diagnostic company utilizing its proprietary proteomics and bioinformatics platform, and significant data resources to enhance maternal and neonatal health by discovering, developing, and commercializing blood-based biomarker tests, and predictive analytic products and services. It has built a proteomics and bioinformatics platform to characterize the biology of pregnancy and to discover and validate key protein biomarkers found in blood that are accurate predictors of dynamic changes that occur during pregnancy. Its commercial product, the PreTRM test, is a validated, commercially available blood-based biomarker test to predict the risk of a premature delivery, also known as preterm birth. The PreTRM test is a non-invasive blood test given to a pregnant woman, carrying a single fetus, during weeks 18 through 20 of gestation that provides a prediction of the expectant motherâs risk of delivering spontaneously before 37 weeksâ gestation.