The long term objective of this proposal is commercialization of a test for the management of cancer. Immunicon has developed a sensitive test for detecting tumor cells in peripheral blood. This test uses ferrofluids and magnetic separation technology for tumor cell enrichment and multidimensional flow cytometry for cell analysis. Clinical data show that tumor cells exist in the blood of breast cancer patients. One limitation of this test is that flow cytometry does not confirm the identity of the events that are detected. Morphologic features of cells of immunophenotypically identified events can improve the specificity of the test. These features can be obtained using multicolor fluorescent microscopy. The quantity of ferrofluid used to capture tumor cells from blood, however, can obscure the cell. Phase I feasibility data show that proposed new methods helped to decrease ferrofluid without sacrificing the sensitivity of the test and the proposed objectives were achieved. Feasibility data also shows that incorporating these methods into new assay procedures permits microscopy analysis - a significant breakthrough.
The aim of this Phase II proposal is to adapt these new procedures which incorporate the Phase I developments to further develop and validate the test to detect cancer cells present in blood using multi color fluorescent microscopy.
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