The invention relates to a diagnostic method and related compositions for
characterizing disseminated and micrometastasized cancer cells in body
fluids using DNA, mRNA and/or protein. According to the method, DNAs,
mRNAs and/or proteins of cancerous and non-cancerous cells obtained from
a body fluid (i.e., cell preparations that are not enriched for cancer
cells) and DNAs, mRNAs and/or proteins of cancerous cells that are
removed from the body fluid (i.e., cell preparations that are enriched
for cancer cells) are analyzed, to determine the presence or expression
in body fluid cells of at least one cancer-specific gene that is not
expressed in non-cancer cells or of at least one cancer-associated gene,
and of at least one cancer-specific or cancer-associated gene in cancer
cells removed from the body fluid cells (i.e., in isolated cancer cells).
Also provided are compositions and methods for testing antineoplastic
substances and anticancer therapies by characterizing a cancer-specific
or a cancer-associated gene, and examples of cancer-specific and
cancer-associated genes, including tissue-specific genes, tumor
suppressor genes, oncogenes and others.