Patent ID: 7863012

Claim:
A method for monitoring malignancy in a test subject comprising: a. obtaining a blood sample from a test subject, said sample comprising a mixed cell population suspected of containing intact malignant cancer cells of epithelial cell origin and further comprising: i. cell fragments derived from said malignant cells, and/or ii. cellular debris derived from said malignant cells; b. preparing a sample with magnetically-labeled said intact malignant cells, said cell fragments and said cellular debris wherein said blood sample is mixed with colloidal magnetic particles, having a size range between 90 to 150 nm and a bovine serum albumin coating using high temperature, coupled to a first biospecific ligand which reacts and binds specifically to an epitope present in each of said intact malignant cells, said cell fragments and said cellular debris to form specific binding complexes with said colloidal magnetic particles and first biospecific ligand; c. exposing said specific binding complexes formed in step b) to an externally-applied high gradient magnetic field to the substantial exclusion of other specimen components; d. contacting said specific binding complexes in step c) with at least one additional biospecific ligand forming a specific binding pair with a receptor of said intact malignant cells, said cell fragments and said cellular debris, to the substantial exclusion of other specimen components, wherein the receptor is present in malignant tumor cells of epithelial cell origin; e. differentially analyzing amounts of said labeled malignant cells, said labeled cell fragments and said labeled cellular debris in step d) over time, a change in the numerical proportions of said labeled malignant cells, said labeled cell fragments, and said labeled cellular debris indicating a change of malignancy.