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Study of nearly 30,000 cases finds that non-invasive cfDNA screening for fetal aneuploidy in pregnancies with twins, triplets, and higher-order multiples meets or exceeds performance of singleton pregnancy screening
The study, conducted by leading LabCorp geneticists, assesses the reliability and accuracy of cfDNA screening in multifetal pregnancies by examining four areas: current experiences with biochemical screening in twins, the observed performance of cfDNA screening in multiples, the cfDNA screening positivity rate, and total non-reportable rate in all multifetal gestations. Of the 750,000 samples received by LabCorp for MaterniT21 PLUS screening during the study period of
Previous clinical validation studies in singleton pregnancies have established the high sensitivity and specificity of cfDNA screening, as well as increased detection rates, lower false-positive rates, and higher positive-predictive values over that of conventional prenatal screening methods. This study found that cfDNA screening in patients with multifetal gestations meets or exceeds performance from original clinical validation studies on singleton pregnancies. The collective positivity rate of resulted samples in the study was 2.19%. Positive rates for trisomy 21, 18 and 13 were 1.5%, 0.48% and 0.21% respectively. The average fetal fraction was 12.33% in twins and 13.20% in triplets. The quantity-not-sufficient (QNS) non-reportable rate was higher in multifetal vs singleton pregnancies, which is related to more stringent fetal fraction requirements for multiple gestations as compared to singletons.
The study is the largest published sample of the use of non-invasive prenatal cfDNA screening on twins, triplets, and higher-order multiples. The data on 709 triplets is particularly significant because there are currently no other non-invasive prenatal laboratory screening options available in these pregnancies. In addition, current clinical practice guidelines do not recommend the use of cfDNA in aneuploidy screening in women with multiple gestations. This study significantly increases the body of evidence supporting cfDNA as a robust alternative to traditional prenatal screening methodologies in multifetal pregnancies.
“Aneuploidy screening plays a significant role in determining whether pregnancies may be at higher risk for certain genetic conditions or birth defects,” said
The study, titled “A New Era in Aneuploidy Screening: cfDNA Testing in >30,000 Multifetal Gestations: Experience at
LabCorp (NYSE:LH), an
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