SBIR Phase II: Magnetic Capture Device for Rapid Isolation of Rare Cells

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to develop a technology to enable personalized healthcare for patients. This project will create a separation device to recover rare cells, including circulating tumor cells (CTC) from cancer, which can be analyzed for genetic mutations. In the long term, this information could direct cancer therapy for each patient. Currently available CTC tests only count rare cancer cells, which is of limited value to doctors. This SBIR project will produce an automated system to capture cancer cells from blood, and recover live cells for analysis. Through a small sample of blood, a cancer patient's tumor may be genotyped, which may enable custom therapy in the future. The platform has many research and clinical uses for any type of rare cell capture and analysis. The proposed automated cell separation device will enable the translation of basic research to clinical application by simplifying the rare cell isolation process. This SBIR Phase II project proposes to develop an improved device for the detection and analysis of circulating tumor cells (CTCs) shed into the blood from cancer sites. CTCs are part of the process of spreading cancer, and early detection is key to improved treatment. Detection, quantification, and characterization of CTCs has the potential to transform oncology, yet isolation under routine conditions of these rare, one-in-a-billion cells, remains problematic. The proposed CTC sample preparation technology under development is low-cost, rapid, and potentially may provide a highly informative analysis of captured cells. It promises to enable a new generation of cancer diagnostics that impact patient care. During this Phase II project, the goal is to design and produce the separation device, a fluidic workstation, and supply kit; then, evaluate its ability to capture and recover CTCs from the blood of cancer patients. The Phase I data demonstrate the feasibility of this approach. The results of this study will evaluate alternative means of capturing and recovering CTCs, with the goal of>90% recovery of cells in a procedure requiring 60 minutes or less. A secondary goal of Phase II is to evaluate the potential of the device for the isolation of fetal cells from maternal blood, which could enable noninvasive prenatal diagnostics.