Process for multi-analyses of rare cells extracted or isolated from biological samples through filtration

Abstract

A process for isolating or extracting rare cells from a biological sample comprising filtering a biological sample, which may be treated or diluted, through a filter that has a pore size, pore density or other physical properties that retain rare cells, but which permits other kinds of cells to pass through the filter. This process also comprises multiple analyses performed on rare cells after their extraction or isolation by filtration to diagnostically identify the presence of rare cells in a biological sample and to use their diagnostic identification and molecular characterization for diagnostic purposes such as for early diagnosis of diseases, namely for early diagnosis of cancer and to select, guide, monitor treatments and in particular to select targeted treatments and to monitor the response and/or resistance to them. A kit comprising tools, equipment and/or reagents to accomplish both the filtration step and various kinds of multiple analyses performed after isolation and extraction of the rare cells by filtration.

1 . A process for identifying, diagnosing, or providing a prognosis for a condition, disorder or disease associated with rare cells comprising:
 (a) isolating or extracting rare cells by passing a biological sample through a filter and recovering the isolated rare cells on the filter; wherein the filter has a pore size, pore density or other physical characteristics that retain rare cells but which permit passage of other kinds of cells;   (b) determining the cytomorphology of the isolated or extracted rare cells, and/or immunolabeling the isolated rare cells, and/or performing molecular analysis on the isolated rare cells; and   (c) identifying, diagnosing, or providing a prognosis for a condition, disorder or disease and/or a stage of a condition, disorder or disease associated with the rare cells presence and/or number and/or characteristics based on the cytomorphology, and/or immunolabeling, and/or molecular analysis of the isolated or extracted rare cells.   
     
     
         2 - 20 : (canceled)