Development of novel instrumentation and techniques for CTC selection and analysis in point-of-care (PoC) settings is essential in order to fully realize the diagnostic potential of CTCs. This Phase II project is focused on the development of an integrated, portable, system (i.e., disposable fluidic cartridge, instrument, and assay) for the rapid and fully automated processing of CTCs directly from whole blood.
The specific aims are focused on: (i) Addressing the technical challenges emanating from the Phase I research related to the cartridge and instrument construction and operation;(ii) expansion of the instrument capabilities and ease of use by the addition of imaging functionality;and (iii) performance verification of the instrument for providing clinical utility via studies of pancreatic ductal adenoma carcinoma, PDAC, a disease that has not been serviced well by the FDA-approved system. The instrument will be able to directly process whole blood, select CTC sub-populations at >90% recovery and >80% purities, electronically enumerate CTCs, fluorescently label them with a set of nuclear and immunological stains, and image the selected CTCs. Operation of the instrument will be automated with overall sample-to-answer processing time of ~1.5 h. The final product of this Phase II effort will meet a set of targeted regulatory requirements for FDA-approval and CLIA moderate complexity.