BIOFLUIDICA, INC. — Department of Health and Human Services SBIR Phase I: NICHD

Description

Building on a history of success in developing microfluidic platforms to advance individualized cancer care and treatmentBioFluidicaIncis now focusing its efforts on developing a microfluidic approach for non invasive prenatal testingNIPTto identify genetic abnormalities and inform prenatal and perinatal careMaternal blood contains a host of fetal biomarkers that can be used for non invasive prenatal testingNIPTCurrent commercial NIPT approaches rely on the isolation and molecular analysis of circulating cell free fetal DNAThese tests have demonstrated success in reducing the risks associated with amniocentesis and other invasive approachesHoweverdue to the high background of maternal cell free DNA in circulationcurrent NIPT approaches cannot detect single copy genetic abnormalities that lead to most birth defects and spontaneous miscarriageTo meet this needBioFluidica is developing a cell based microfluidic approach to capture wholeintact fetal trophoblast cells that are in maternal circulationBecause each trophoblast carries a complete and single copy of the fetal genomethe technologies to achieve efficient and cost effective isolation of this unique cell type holds the key to advancing risk freenon invasiveand comprehensive prenatal genomic testing and diagnosticsBuilding on our Liquid Scan technology that is advancing individualizedpatient specific cancer care and treatmentthe objective of this Phase I proposal is to develop a microfluidic platform for the isolation and enrichment of circulating trophoblasts from maternal bloodLeveraging our previous success will evaluate the potential of several cell surface antigens to target for microfluidic captureAimWe will optimize microfluidic capture efficiency and demonstrate the feasibility of downstream cell and molecular analysis of captured cellsAimWe will demonstrate the preclinical utility of the microfluidic device with the capture of circulating trophoblasts from maternal blood collected during pregnancy with a high recovery rate and purityAimOur long term goal is the development of a fully integrated and automated microfluidic platform for the enrichment of fetal trophoblast cells with high recovery and reproducibilityThe platform will provide high specificity and throughputand be cost effective as a commercially viable technology The potential to use fetal cells in the mother s circulation during the first or second trimester for prenatal diagnosis was first proposed nearly fifty years agobut this goal has yet to be fully realizedBioFluidica s Liquid Scan platform is filling that gap with microfluidic technology optimized for the rapid capture of highly pure fetal trophoblast cell populations from a simple blood drawThis technology holds promise to become the first noninvasive prenatal test broadly used for prenatal testing and diagnosis