Novel forms of prostate specific antigen (PSA) specific for benign prostatic hyperplasia (BPH) and methods of using such

An antibody that is preferentially reactive with a form of PSA that comprises at least one clip at Lys 182 of the amino acid sequence of a mature form of PSA.

An immunogen that is capable of eliciting a monoclonal antibody which preferentially binds to a novel form of PSA comprising at least one clip at Lys 182 of the amino acid sequence of a mature form of PSA.

A hybridoma cell line capable of producing a monoclonal antibody that preferentially binds a novel form of PSA comprising at least one clip at Lys 182 of the amino acid sequence of a mature form of PSA.

A method of producing monoclonal antibodies which preferentially binds to a novel form of PSA comprising at least one clip at Lys 182 of a mature form of PSA, the method comprising steps of:

• (a) immunizing a mouse with a novel form of PSA;
• and
• (b) producing monoclonal antibodies from the immunized mouse by employing a monoclonal antibody technique, wherein the monoclonal antibodies preferentially bind to the novel form of PSA compared to other forms of free PSA.

A method of detecting, or determining in a sample, a form of prostate specific antigen (PSA) comprising at least one clip at lysine 182 of the amino acid sequence of a mature form of PSA, the method comprising the steps of:

• (a) contacting an amount of an agent which specifically binds to the form of PSA to be detected with the sample under a condition that allows the formation of a binary complex comprising the agent and the form of PSA;
• and
• (b) detecting or determining the presence or amount of the complex.

A test kit for detecting or determining in a sample the form of PSA comprising at least one clip at lysine 182 of the amino acid sequence of a mature form of PSA, the kit comprising a known amount of an agent which preferentially binds to the form of PSA to be detected, wherein the agent is detectably labeled or binds to a detectable label.

A method for distinguishing benign prostate hyperplasia from prostate cancer comprising:

• (a) contacting an amount of an agent, which preferentially binds to a form of PSA comprising at least one clip at lysine 182 of the amino acid sequence of a mature form of PSA, with a sample obtained from a human containing the form of PSA under a condition sufficient to allow the formation of a binary complex comprising the agent and the form of PSA;
• and
• (b) determining the amount of the complex in the sample and correlating the amount of the complex to the presence or absence of benign prostatic hyperplasia or prostate cancer in the human.

The method of claim 50, wherein the form of PSA comprises two clips at Lys 145 and Lys 182 of the amino acid sequence of a mature form of PSA.