Ronald Seubert

The RareCyte® platform for next-generation analysis of circulating tumor cells: RareCyte platform CTC analysis

Circulating tumor cells (CTCs) can reliably be identified in cancer patients and are associated with clinical outcome. Next‐generation “liquid biopsy” technologies will expand CTC diagnostic investigation to include phenotypic characterization and single‐cell molecular analysis. We describe here a rare cell analysis platform designed to comprehensively collect and identify CTCs, enable multi‐parameter assessment of individual CTCs, and retrieve single cells for molecular analysis. The platform has the following four integrated components: 1) density‐based separation of the CTC‐containing blood fraction and sample deposition onto microscope slides; 2) automated multiparameter fluorescence staining; 3) image scanning, analysis, and review; and 4) mechanical CTC retrieval. The open platform utilizes six fluorescence channels, of which four channels are used to identify CTC and two channels are available for investigational biomarkers; a prototype assay that allows three investigational biomarker channels has been developed. Single‐cell retrieval from fixed slides is compatible with whole genome amplification methods for genomic analysis.