Glycodelin monoclonal antibodies and methods for their use in the detection of ovarian cancer

A method for diagnosing ovarian cancer in a patient comprising:

• (a) contacting a serum sample from a patient with at least one antibody that selectively binds to glycodelin, wherein said at least one antibody that selectively binds to glycodelin is selected from the group consisting of:
• (i) the monoclonal antibody produced by the hybridoma cell line 2G7.1, deposited with the ATCC as Patent Deposit No. PTA-9684, or an antigen binding fragment thereof;
• (ii) the monoclonal antibody produced by the hybridoma cell line 8G8.3, deposited with the ATCC as Patent Deposit No. PTA-9685, or an antigen binding fragment thereof;
• (iii) the monoclonal antibody produced by the hybridoma cell line 3A10.25, deposited with the ATCC as Patent Deposit No. PTA-9686, or an antigen binding fragment thereof;
• (iv) a monoclonal antibody or an antigen binding fragment thereof comprising a heavy chain variable region comprising complementarity determining regions (CDRs) comprising the amino acid sequences of the CDRs of the heavy chain variable region of the antibody produced by the hybridoma cell line deposited with the ATCC as Patent Deposit No. PTA-9684 and a light chain variable region comprising CDRs comprising the amino acid sequences of the CDRs of the light chain variable region of the antibody produced by the hybridoma cell line deposited with the ATCC as Patent Deposit No. PTA-9684, which specifically binds to glycodelin;
• (v) a monoclonal antibody or an antigen binding fragment thereof comprising a heavy chain variable region comprising CDRs comprising the amino acid sequences of the CDRs of the heavy chain variable region of the antibody produced by the hybridoma cell line deposited with the ATCC as Patent Deposit No. PTA-9685 and a light chain variable region comprising CDRs comprising the amino acid sequences of the CDRs of the light chain variable region of the antibody produced by the hybridoma cell line deposited with the ATCC as Patent Deposit No. PTA-9685, which specifically binds to glycodelin;
• and
• (vi) a monoclonal antibody or an antigen binding fragment thereof comprising a heavy chain variable region comprising CDRs comprising the amino acid sequences of the CDRs of the heavy chain variable region of the antibody produced by the hybridoma cell line deposited with the ATCC as Patent Deposit No. PTA-9686 and a light chain variable region comprising CDRs comprising the amino acid sequences of the CDRs of the light chain variable region of the antibody produced by the hybridoma cell line deposited with the ATCC as Patent Deposit No. PTA-9686, which specifically binds to glycodelin;
• (b) detecting binding of the antibody to any glycodelin that is contained in the serum sample;
• and
• (c) determining that there is an indication that the patient has ovarian cancer when the amount of glycodelin detected in the serum sample from the patient exceeds the amount of glycodelin in a serum sample from a subject not having ovarian cancer.

A method for diagnosing ovarian cancer in a patient comprising the steps of:

• (a) contacting a serum sample from the patient with a glycodelin capture antibody immobilized on a solid support;
• (b) contacting the sample bound to the solid support with a glycodelin detector antibody;
• (c) detecting and quantifying any glycodelin in the sample;
• and
• (d) determining that there is an indication that the patient has ovarian cancer when the amount of glycodelin detected and quantified in the serum sample from the patient is greater than the amount of glycodelin in a serum sample from a subject not having ovarian cancer
• wherein the glycodelin detector antibody is selected from the group consisting of:
• (i) the monoclonal antibody produced by the hybridoma cell line 8G8.3, deposited with the ATCC as Patent Deposit No. PTA-9685, or an antigen binding fragment thereof;
• (ii) the monoclonal antibody produced by the hybridoma cell line 3A10.25, deposited with the ATCC as Patent Deposit No. PTA-9686, or an antigen binding fragment thereof;
• (iii) a monoclonal antibody or an antigen binding fragment thereof comprising a heavy chain variable region comprising complementarity determining regions (CDRs) comprising the amino acid sequences of the CDRs of the heavy chain variable region of the antibody produced by the hybridoma cell line deposited with the ATCC as Patent Deposit No. PTA-9685 and a light chain variable region comprising CDRs comprising the amino acid sequences of the CDRs of the light chain variable region of the antibody produced by the hybridoma cell line deposited with the ATCC as Patent Deposit No. PTA-9685, which specifically binds to glycodelin;
• and
• (iv) a monoclonal antibody or an antigen binding fragment thereof comprising a heavy chain variable region comprising complementarity determining regions (CDRs) comprising the amino acid sequences of the CDRs of the heavy chain variable region of the antibody produced by the hybridoma cell line deposited with the ATCC as Patent Deposit No. PTA-9686 and a light chain variable region comprising CDRs comprising the amino acid sequences of the CDRs of the light chain variable region of the antibody produced by the hybridoma cell line deposited with the ATCC as Patent Deposit No. PTA-9686, which specifically binds to glycodelin.