Methods for diagnosing disease, diagnosing malignancy, screening for malignancy, and monitoring malignancy in an individual under test and kit for examining a biological specimen for the presence of malignant cells, malignant cell-derived cell debris or malignant cell-derived cell debris

摘要

"METHODS TO DIAGNOSE DISEASE, DIAGNOSIS malignancy, sorting malignancy AND MONITOR malignancy, in an individual UNDER TEST, E, KIT TO CHECK A specimen biological and the CELLS MALIGNANT PRESENCE, FRAGMENTS CELL DERIVED CELLS MALIGNANT OR DEBRIS CELLULAR CELLS DERIVED FROM MALIGNANT" . The methods and reagents described in this invention are used to analyze circulating tumor cells, clusters, fragments and debris. Analysis is performed with numerous platforms, including flow cytometry and the CellSpotter 32 * fluorescent microscopy imaging system. Analysis of damaged cells has been shown to be important. However, there are two sources of malfunction: in vivo and in vitro. In vivo malfunction occurs by apoptosis, necrosis or immune response. In vitro malfunction occurs during handling of sample acquisition, transport, processing or analysis. Therefore, it is desirable to confine, reduce, eliminate or at least qualify for in vitro damage to prevent it from interfering with the analysis. Methods for diagnosing, monitoring, and selecting circulating rare cell-based disease, including malignancy as determined by CTC, clusters, fragments, and debris, are described herein. Kits for examining biological specimens using these methods are also provided.