Patent ID: 7732157

Claim:
An assay for determining the concentration of a soluble epidermal growth factor receptor in a biological sample from a female patient, the assay comprising: a) obtaining a biological sample from the female; b) contacting an amount of a first purified antibody that specifically reacts with a first epitope of the extracellular ligand binding domain of soluble epidermal growth factor receptor with the biological sample to be tested, wherein the first purified antibody is modified with a first labeling moiety; c) contacting the sample with an amount of a second purified antibody that specifically reacts with a second epitope of the extracellular ligand binding domain of soluble epidermal growth factor receptor, wherein the second purified antibody is modified with a second labeling moiety, and wherein the second purified antibody does not competitively inhibit the binding of the first purified antibody; d) detecting the co-presence of the first and second labels to determine the concentration of the soluble epidermal growth factor receptor complexed with the antibodies; wherein one of the antibodies is chosen from the group consisting of mAb R.1 and an antibody which binds to the same epitope as mAb R.1; and wherein the other antibody is chosen from the group consisting of mAb 528 and an antibody which binds to the same epitope as mAb 528; e) comparing the concentration of soluble epidermal growth factor receptor obtained in step d) with a normal value; and f) correlating a decrease in the concentration of soluble epidermal growth factor receptor in the patient biological sample with the presence of an ovarian carcinoma in the patient.