Patent ID: 8753825

Claim:
A method for detecting a trophoblastic disease in a subject comprising the steps of: (i) contacting in one assay 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 at least one detection antibody that binds an epitope of the ITA 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; (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) determining an amount of ITA present in the biological sample based on the detected signal in step (ii), wherein an amount of ITA greater than about 400,000 ng/ml, indicates the presence of a trophoblastic disease.