In the report, Menarini’s non-invasive cell-based prenatal technology demonstrates high-resolution detection of fetal genetic abnormalities from a simple maternal blood draw. 02-Jul-2024 Via PR Newswire by Menarini Silicon Biosystems, the company advised us that the subtitle and the second sentence of the second paragraph should read „400 Kb” instead of 600 Kb, as it was inadvertently sent. A complete and revised version will follow. :
Menarini’s non-invasive cell-based prenatal technology demonstrates high-resolution detection of fetal genetic abnormalities from a simple maternal blood draw.
Data presented in the World FMF (Fetal Medicine Foundation) 2024 Lisbon, Portugal, showing the potential of an automated system to provide genomic profiles of fetal cells with high concordance with genomic analysis obtained through invasive procedures. Results of a large clinical validation study demonstrate that Menarini Silicon Biosystems’ fetal cell-based non-invasive prenatal screening technology can accurately detect two pathogenic copy number variants across the fetal genome of more than 400 Kb, according to commonly tested trisomy levels.
Bologna, Italy and Huntington Valley, Pa., July 2, 2024 /PRNewswire/ — Menarini Silicon Biosystems’ (MSB) Precision Reproductive Medicine division presented at the 21st World Congress of the Foundation for Fidal Medicine last week. Lisbon, Portugal, the results of a large multicenter study of their new generation of noninvasive prenatal tests using fetal cells isolated from maternal blood. Genetic analysis of these embryonic cells shows high agreement with analysis of embryonic cells obtained by invasive diagnostic procedures. In addition, the MSB cellular test, under development, is based on cell-free DNA analysis (cfDNA) for its potential validity in screening for genetic conditions not readily detectable by currently available next-generation non-invasive screening technologies.
This large study involving more than 1,000 women focused on isolating individual fetal (trophoblastic) cells from maternal blood and analyzing both common trisomy conditions and genome-wide microdeletions and microduplications for significant perinatal morbidity and mortality. The results show that MSB’s embryonic stem cell-based NIPT test can provide information beyond the common trisomies detected by standard cfDNA analysis, as well as detect highly accurate and detailed microdeletions and microduplications in the genome up to at least 400 Kb in size. The cell-based test was compared with chromosome microarray analysis (CMA) and chorionic villus sampling (CVS) karyotyping or amniocentesis, which are gold standard clinical methods for detecting chromosomal abnormalities in the prenatal setting.
According to the author John HydeHead of Maternal and Fetal Medicine at the hospital D Liverpool of SydneyProfessor of Obstetrics and Gynecology at the Univ Western SydneyIt addresses high-risk pregnancies for both mother and fetus: „These data demonstrate the ability of current screening tests to provide clinically relevant information about fetal genetic abnormalities with higher accuracy than current screening tests, early in pregnancy, when pCNV is almost undetectable.” Menarini’s new study paves the way for a new paradigm in prenatal screening.
Dr. Thomas Masci, Chief Medical Officer and Head of the Precision Reproductive Medicine Business Unit at Menarini Silicon Biosystems, who presented the results of the study, said, «Isolation of intact fetal cells from maternal blood for prenatal screening has long been considered a more difficult goal. „Our highly automated system for single-cell isolation and analysis of circulating extracellular trophoblasts (CEVTs) supports the potential of cell-based NIPT for fetal genetic profiling, leading to more informed decision-making at all levels.”
Menarini has invested heavily in the advancement of sequencing in the field of single-cell analysis and breeding. To Fabio Piazzlunga, President of Menarini Silicon Biosystems, „The results of this study confirm the ability of our cell-based NIPT to identify fetal abnormalities with high sensitivity, accuracy and specificity, thus demonstrating Menarini’s potential to have a significant impact on women’s health.” and aim to provide a potentially revolutionary solution that provides additional information to their physicians.” These new functions fully support the company’s vision to be a leader in minimally invasive cellular applications that enable easier, faster and more accurate diagnostic and therapeutic approaches in multiple therapeutic areas.
About Menarini Silicon Biosystems (MSB).
MSB offers unique rare cell technologies and solutions that allow medical researchers to access unparalleled resolution in the study of cells and their molecular characterization.
Menarini Silicon BiosystemsBasically Castel Maggiore (Bologna, Italy) and Huntington Valley, Pennsylvania, United States, is a wholly owned subsidiary of the Menarini Group, a multinational pharmaceutical, biotechnology and diagnostics company headquartered in Florence, Italy, with 17,000 employees in 140 countries.
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