Patent ID: 6927034

Claim:
A method for detecting a gestational trophoblast malignancy in a subject who is either pregnant or suspected of being pregnant, comprising the steps of: (a) (i) contacting a first portion of a urine sample from the subject with an antibody which binds to EPMI-hCG under conditions permitting the formation of a complex between the antibody and any EPMI-hCG present in the sample, wherein the antibody which binds to EPMI-hCG is B152, produced by the hybridoma deposited with the American Type Culture Collection under Designation No. HD-12467; and (ii) measuring the amount of any complex formed, so as to thereby determine the amount of EPMI-hCG in the sample; (b) (i) contacting a second portion of the urine sample from the subject with an antibody which binds to intact hCG under conditions permitting the formation of a complex between the antibody and any intact hCG present in the sample; and (i) measuring the amount of any complex formed, so as to thereby determine the amount of intact hCG in the sample, with the proviso that steps (a) and (b) can be performed in any order; (c) determining the ratio of EPMI-hCG to intact hCG in the sample from the measurements performed in (a) (ii) and (b) (ii); and (d) repeating steps (a) through (c) at least once over a suitable time period, wherein a ratio of EPMI-hCG to intact hCG greater than 1.0 occurring over such time period indicates the presence of a gestational trophoblast malignancy.