Analytical validation of the CellMax platform for early detection of cancer by enumeration of rare circulating tumor cells.

ABSTRACT: The CellMax (CMx®) platform was developed to enrich for epithelial circulating tumor cells (CTCs) in the whole blood. This report provides assay performance data, including accuracy, linearity, limit of blank, limit of detection (LOD), specificity, and precision of enumeration of cancer cell line cells (CLCs) spiked in cell culture medium or healthy donor blood samples. Additionally, assay specificity was demonstrated in 32 young healthy donors and clinical feasibility was demonstrated in a cohort of 47 subjects consisting of healthy donors and patients who were colonoscopy verified to have colorectal cancer, adenomas, or a negative result. The CMx platform demonstrated high accuracy, linearity, and sensitivity for the enumeration of all CLC concentrations tested, including the extremely l

SUBMITTER: Gupta P 

PROVIDER: S-EPMC6939390 | biostudies-literature | 2019 Jan-Dec

REPOSITORIES: biostudies-literature