BioFluidica™ Announces Promising New Data for Identifying Fetal Aneuploidy Using the LiquidScan™, a High Throughput Liquid Biopsy Platform.
SAN DIEGO, Oct. 1, 2021 /PRNewswire/ -- BioFluidica™, a privately held biotechnology company, today announced the publication of promising new data from its collaboration with Wright State University and Premier Heath, Dayton, Ohio, in the journal Prenatal Diagnosis. It shows that chromosome abnormalities (aneuploidy) can be identified in fetal cells isolated from maternal circulation during pregnancy using BioFluidica's high-throughput, high-sensitivity microfluidic system, the LiquidScan™.
"The data demonstrates the novel platform LiquidScan™ can capture and enrich circulating trophoblasts for diagnosing fetal chromosome abnormalities," said Rolf Muller, CEO of BioFluidica. "Our technology, coupled with an established technique like fluorescence in situ hybridization (FISH), has the potential for enabling non-invasive cell-based prenatal test (NIPT) for diagnosing chromosome abnormalities."
The study, titled Identification of fetal aneuploidy with dual-probe fluorescence in situ hybridization analysis in circulating trophoblasts after enrichment using a high-sensitivity microfluidic platform in Prenatal Diagnosis, the official Journal of the International Society for Prenatal Diagnosis (Sonek, et al., Prenatal Diagn 2021:1-8. doi:10. 1002/pd.6046), consisted of pregnant women known to have or strongly suspected of having a fetus affected by aneuploidy. All fetuses had anomalies identified on ultrasound and an abnormal result of at least one of the following: NIPS, amniocentesis, or CVS. Samples from all trimesters were included. Whole blood samples were collected from patients via venipuncture, preserved in a proprietary buffer, shipped overnight from Ohio to California at ambient temperature, and run through the LiquidScan™ system within 24 hours of collection.
The LiquidScan™ was used to isolate circulating trophoblasts (outer cells of the placenta) while minimizing capture of background maternal cells from the blood of the study participants. Fetal chromosome abnormalities were successfully identified in each of the nine samples using fluorescent in situ hybridization (FISH), a well-established and reliable imaging technique for diagnosing aneuploidy. The study shows that the LiquidScan™ is effective at capturing fetal cells and identifying five different types of common aneuploidies (trisomies 21, 18, and 13; monosomy X; triploidy) irrespective of gestational age or maternal weight.
"It demonstrates that BioFluidica's microfluidic technology, an automated, scalable, and comparatively inexpensive approach has a potential to be used for non-invasive diagnosis of fetal chromosome abnormalities," said Jiri Sonek, a Maternal-Fetal specialist and President of the Fetal Medicine Foundation USA. "The fact that whole fetal cells are available for evaluation opens the door to the possibility for a more complete testing of the entire fetal genome."
Due to its wider diagnostic potential, this whole-cell non-invasive diagnostic prenatal test (NIPT) promises to be an improvement over the cell-free DNA non-invasive prenatal screening (NIPS) currently available.
BioFluidica is a privately held biotechnology company that has developed a revolutionary platform enabling disease management and diagnosis through prognosis, all from a simple blood test. The BioFluidica microfluidic platform can capture and isolate disease biomarkers, such as Circulating Tumor Cells (CTC), and has been clinically validated. Its ability to scan whole blood for the first signs of a disease, finding the rarest biomarkers with unmatched sensitivity, means fulfilling the promise of a true liquid biopsy. BioFluidica is revolutionizing disease detection by bringing better samples to millions of people. For more information please visit https://www.biofluidica.com/
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SOURCE BioFluidica, Inc.