MaterniT21 laboratory-developed test diagnostic data

Additional data from a blinded, nested case-control validation study analyzing 62 trisomy 18 and 12 trisomy 13 pregnancies and their unaffected matched controls showed that Sequenom's MaterniT21 LDT had 100% sensitivity and 99.72% specificity for detecting fetal trisomy 18 Edwards syndrome and 91.7% sensitivity and 99.03% specificity for detecting fetal trisomy 13 Patau syndrome. The study analyzed maternal plasma samples from 4,664 women at 10-22 weeks gestation who were at high-risk for fetal aneuploidy. Sequenom previously reported data from 212 Down syndrome and 1,484 unaffected matched control pregnancies in the study showing that the MaterniT21 LDT had 98.6% sensitivity and 99.8% specificity for detecting fetal trisomy 21 Down syndrome (see BioCentury, Oct. 24, 2011). ...