The CytoTrapNano™ CTC Enumeration System is a semi-automatic system that can capture and quantify CTCs from a standard blood sample with a high level of sensitivity and specificity.  The CytoTrapNano™ system is comprised of the following three components: 1) the chip holder and fluidic handler to house the CytoTrapNano™ Chip and overlaid PDMS chaotic mixer, allowing for highly efficient CTC capture from a pre-processed blood sample, 2) a fluorescence microscope for imaging CTCs immobilized on a CytoTrapNano™ Chip, and 3) reagent kits.  In general, it takes less then 3 h to run multiple CTC enumeration studies in parallel using an array of CytoTrapNano™ Systems.

CytoLumina is developing a premarket notification based on the successful demonstration of substantial equivalence of the CytoTrapNano™ to the CellSearch™ Epithelial Cell Kit/Cell Spotter Analyzer (Veridex, Raritan, NJ) cleared under K073338, for the purpose of enumerating CTCs in patients with metastatic prostate cancer.