BURLINGTON, N.C.--(BUSINESS WIRE)--LabCorp® (NYSE:LH), a leading global life sciences company that is deeply integrated in guiding patient care, recently published results of the largest study to date of cell-free DNA (cfDNA) screenings in multifetal pregnancies. The study, published in PLOS ONE, determined that non-invasive cfDNA screening using the MaterniT21® PLUS test offered by LabCorp’s Integrated Genetics provided reliable results that compare favorably to those for singleton pregnancies. A woman’s age-related risk for aneuploidy in most multifetal pregnancies is elevated compared to that of a woman of the same maternal age carrying a singleton pregnancy, and reliable cfDNA screening can provide valuable information to help guide care decisions.
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 October 2011 to December 2017, 4% (approximately 30,000 samples) were from multifetal pregnancies.
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 Marcia Eisenberg, Ph.D., chief scientific officer, LabCorp Diagnostics. “The rate of multifetal pregnancies has increased dramatically over the past several decades, but it has taken time to accumulate the number of patients and the corresponding data needed to support these new screening options for those patients and their providers. This study shows that aneuploidy screening using MaterniT21 PLUS is reliable for multifetal and singleton pregnancies. We hope that the findings of this significant study will encourage broader adoption of aneuploidy screening in clinical practice and coverage by health insurers. LabCorp’s commitment to research, including the development of new tests and determining the most effective ways that existing tests can be used, is an important part of our mission to improve health and improve lives.”
The study, titled “A New Era in Aneuploidy Screening: cfDNA Testing in >30,000 Multifetal Gestations: Experience at One Clinical Laboratory,” was published by PLOS ONE on August 8, 2019, and it can be accessed here: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0220979.
LabCorp (NYSE:LH), an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostic solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11 billion in 2018. To learn more about LabCorp, visit www.LabCorp.com, and to learn more about Covance Drug Development, visit www.Covance.com.
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