SBIR Phase I: Magnetic Sifter for Rapid Isolation of Rare Cells

This Small Business Innovation Research (SBIR) Phase I project will develop an improved device for the detection and analysis of circulating tumor cells (CTCs). CTCs provide a window into the metastatic process, and are key to early detection and treatment of metastatic cancer. Detection, quantification, and characterization of CTCs has the potential to transform oncology, yet their isolation under routine conditions remains problematic. The CTC sample preparation technology under development is rapid, potentially highly informative through genotyping or phenotypic analysis of captured cells, and low cost. It will enable a new generation of oncodiagnostics that impact patient care. During this Phase I project, the goal is to build a prototype device, then evaluate its ability to capture and recover small numbers of cancer cells from whole blood. The preliminary data demonstrates 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. The broader impact/commercial potential of this project will be a device to recover rare cells that can then be analyzed for informative mutations and chromosomal rearrangements that can inform patient therapy. First generation CTC tests provide only cell counts. While the prognostic value of CTC counts is accepted, many clinicians view the value of these relatively expensive tests with skepticism. The goal of this project is a second generation CTC test that facilitates cell counts, but also recovers captured cells for analysis. Through a simple blood draw, a cancer patient's tumor can be genotyped, and therapy can be tailored accordingly. We describe a versatile platform with many research and clinical applications beyond CTCs. These applications include noninvasive prenatal diagnostics using fetal cells in maternal blood, and stem cell isolation for regenerative medicine. A device based on the same separation principles could be used to isolate stem cells for implantation in infarcted myocardium, non-union bone fractures, and many other tissues. This cell separation device will enable the translation of stem cell research to clinical application by simplifying the cell isolation process.