Determination of cellular growth abnormality, particularly cancerous
abnormality, by detection of target polypeptides or encoding mRNA, where
the target polypeptides are members of the preinitiation complex of DNA
replication in tissue, cells or fluid. Target polypeptides include CDC6,
MCM2, MCM3, MCM4, MCM5, MCM6 and MCM7. Test samples include tissue of the
cervix (both biopsy and smear samples), breast, colon, lung, bladder,
skin, larynx, esophagus, bronchus, lymph nodes and urinary tract (both
biopsy and cytology smear samples), in determination of cancerous and
pre-cancerous cellular growth abnormality, and cells spun from urine,
blood and serum, in determination of hematological malignancies and
evidence of metastatic sarcoma and carcinoma.