title: Development of an Automated and Sensitive Microfluidic Device for Capturing and Characterizing Circulating Tumor Cells (CTCs) from Clinical Blood Samples.
abstract: Current analysis of circulating tumor cells (CTCs) is hindered by sub-optimal sensitivity and specificity of devices or assays as well as lack of capability of characterization of CTCs with clinical biomarkers. Here, we validate a novel technology to enrich and characterize CTCs from blood samples of patients with metastatic breast, prostate and colorectal cancers using a microfluidic chip which is processed by using an automated staining and scanning system from sample preparation to image processing. The Celsee system allowed for the detection of CTCs with apparent high sensitivity and specificity (94% sensitivity and 100% specificity). Moreover, the system facilitated rapid capture of CTCs from blood samples and also allowed for downstream characterization of the captured cells by immunohistochemistry, DNA and mRNA fluorescence in-situ hybridization (FISH). In a subset of patients with prostate cancer we compared the technology with a FDA-approved CTC device, CellSearch and found a higher degree of sensitivity with the Celsee instrument. In conclusion, the integrated Celsee system represents a promising CTC technology for enumeration and molecular characterization.
authors.affiliation: Celsee Diagnostics, 46701 Commerce Center Drive, Plymouth, Michigan, United States of America.
authors.forename: Priya
authors.initials: P
authors.lastname: Gogoi
authors.affiliation: Celsee Diagnostics, 46701 Commerce Center Drive, Plymouth, Michigan, United States of America.
authors.forename: Saedeh
authors.initials: S
authors.lastname: Sepehri
authors.affiliation: Celsee Diagnostics, 46701 Commerce Center Drive, Plymouth, Michigan, United States of America.
authors.forename: Yi
authors.initials: Y
authors.lastname: Zhou
authors.affiliation: The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Gorin
authors.affiliation: Sidney Kimmel Cancer Center, Department of Cancer Biology, Thomas Jefferson University, Philadelphia, Pennsylvania, United States of America.|Laboratory of Molecular Biology, Department of Laboratory Medicine, University Hospital "A. Gemelli", Rome, Italy.
authors.forename: Carmela
authors.initials: C
authors.lastname: Paolillo
authors.affiliation: Laboratory of Molecular Biology, Department of Laboratory Medicine, University Hospital "A. Gemelli", Rome, Italy.
authors.forename: Ettore
authors.initials: E
authors.lastname: Capoluongo
authors.affiliation: Celsee Diagnostics, 46701 Commerce Center Drive, Plymouth, Michigan, United States of America.
authors.forename: Kyle
authors.initials: K
authors.lastname: Gleason
authors.affiliation: Celsee Diagnostics, 46701 Commerce Center Drive, Plymouth, Michigan, United States of America.
authors.forename: Austin
authors.initials: A
authors.lastname: Payne
authors.affiliation: Celsee Diagnostics, 46701 Commerce Center Drive, Plymouth, Michigan, United States of America.
authors.forename: Brian
authors.initials: B
authors.lastname: Boniface
authors.affiliation: Division of Hematology/Oncology, Robert Lurie Cancer Center, Northwestern University, Chicago, Illinois, United States of America.
authors.forename: Massimo
authors.initials: M
authors.lastname: Cristofanilli
authors.affiliation: Comprehensive Cancer Center, University of Michigan, Ann Arbor, Michigan, United States of America.
authors.forename: Todd M
authors.initials: TM
authors.lastname: Morgan
authors.affiliation: Sidney Kimmel Cancer Center, Department of Cancer Biology, Thomas Jefferson University, Philadelphia, Pennsylvania, United States of America.|Department of Molecular Medicine, University of Rome "Sapienza", Rome, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Fortina
authors.affiliation: The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.
authors.forename: Kenneth J
authors.initials: KJ
authors.lastname: Pienta
authors.affiliation: Celsee Diagnostics, 46701 Commerce Center Drive, Plymouth, Michigan, United States of America.
authors.forename: Kalyan
authors.initials: K
authors.lastname: Handique
authors.affiliation: Celsee Diagnostics, 46701 Commerce Center Drive, Plymouth, Michigan, United States of America.
authors.forename: Yixin
authors.initials: Y
authors.lastname: Wang
mesh_terms: D001331:Automation; D001943:Breast Neoplasms / Q000097:blood; D015179:Colorectal Neoplasms / Q000097:blood; D005260:Female; D006801:Humans; D017404:In Situ Hybridization, Fluorescence; D056656:Lab-On-A-Chip Devices; D008297:Male; D009360:Neoplastic Cells, Circulating; D011471:Prostatic Neoplasms / Q000097:blood