LifeCodexx Completes Clinical Validation of Noninvasive Prenatal Test Method of Trisomy 21
LifeCodexx has announced the successful completion of the clinical validation study of its noninvasive test method for the detection of fetal trisomy 21 from maternal blood using Next Generation sequencing.
LifeCodexx AG has announced the successful completion of the clinical validation study of its noninvasive test method for the detection of fetal trisomy 21 from maternal blood using Next Generation sequencing.
First results from the prospective blinded multi-center study demonstrate highest clinical accuracy for the planned commercial PraenaTest? test design based on Cell-Free DNA? blood collection tubes (BCT), detecting all positive cases of fetal trisomy 21 (100% sensitivity) with no false negative calls (100% specificity).
During the study, five prenatal centers and university hospitals in Germany and Switzerland recruited a total of 522 maternal blood samples from pregnant women with high risk of chromosomal alterations in the unborn child. Gestational
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