Rare cell sublets in peripheral blood, such as circulating tumor cells (CTCs) has been used as biomarkers for cancer progression. In addition, growing evidence suggests that CTC isolation from a blood sample may allow reliable early detection and molecular characterization of cancer at diagnosis or relapse and provide a minimally-invasive method to guide and monitor the results of cancer therapy in cancer patients. Our goal is to commercialize a cost effective point of care device capable of isolating viable CTCs from a wide variety of cancers, for which proof of concept has been achieved in a research setting. For this Phase I proposal, we aim (1) to demonstrate the device feasibility for antibody independent isolation of viable CTCs, (2) to compare performance against the current FDA approved, state-of-the-art CTC isolation technology,and (3) characterize system performance. With the introduction of this technology, CTCs can be isolated from all metastatis cancers and provide a pre-screen diagnostic tool for cancer patients in a point of care setting. Also, unpurterbed and viable state of CTCs will allow systematic biological analysis of individual cells, permitting a personalized approach to cancer therapy.
