Patent ID: 7439026

Claim:
A method for detecting trophoblastic disease in a subject comprising: (i) contacting a biological sample of the subject in a combination assay with at least two capture antibodies that specifically bind different epitopes of invasive trophoblast antigen (ITA), and hCG, and at least one detection antibody that binds an epitope of the ITA and hCG different from the epitopes bound by the capture antibodies, the at least one detection antibody being coupled to a label that is effective to produce a detectable signal in one assay; (ii) detecting a signal produced by the label when the detection antibody is bound to ITA; (iii) confirming that the subject is not pregnant; and (iv) comparing the total ITA and hCG signal generated in the sample to the signal generated in a sample obtained from a normal, non-pregnant subject, wherein an elevated signal in the sample relative to the sample from the normal, non-pregnant subject indicates trophoblastic disease in the subject.