Other

Hybritech Incorporated

Beckman Coulter, Inc.

Baylor College of Medicine

Tang Jang Wang

Stephen D Mikolajczyk

Robert L Wolfert

Harry G Rittenhouse

Kevin Slawin

Kristine Kuus-Reichel

Janice K Payne

Harry Jay Linton

Inactive precursor forms of PSA (pPSA) have been identified to exist in serum and tissues of patients with prostate cancer. Antibodies specific for pPSA are provided. Methods for detecting inactive precursors of PSA in human physiological fluid and tissues are also provided, as well as diagnostic kits and methods useful in the diagnosis and management of prostate cancer.

Forms of prostate specific antigens and methods for their detection

An immunoassay device and assay to detect an antigen, such as PSA, in a biological sample. The device comprises a solid support having multiple reaction zones containing capture antibodies directed to the antigen. Exposure of a test sample to a mixture of incubation antibodies with known and different concentrations prior to exposure to the capture antibodies in the reaction zones facilitates determination of a range of concentrations of the antigen.

Methods and device for detecting prostate specific antigen (PSA)

A substantially pure and isolated novel form of prostate specific antigen (PSA) is provided. The novel form of PSA of the present invention comprises at least one clip at Lys 182 of the amino acid sequence of a mature form of PSA. Preferably, the novel form of PSA additionally comprises one or more clips at a location selected from a group consisting of Ile 1, Lys 145, and Lys 146. More preferably, the form of PSA contains at least two clips at Lys 145 and Lys 182 of the amino acid sequence of a mature form of PSA. The novel forms of PSA exist at an elevated level in patients suspected of having benign prostatic hyperplasia (BPH) and therefore may be used as a serum mark or an immunohistological marker to help distinguish BPH from prostate cancer. Antibodies recognizing the novel forms of PSA and immunoassays that detect and determine the novel forms of PSA of the present invention in a sample are also provided. Further provided are a kit and a method for detecting the novel forms of PSA for aiding in the differentiation of prostate cancer from BPH.

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

A method of distinguishing prostate cancer from benign prostatic hyperplasia (BPH) is provided. The mathematical combination or ratio of proPSA and BPSA serum or tissue markers may be used for distinguishing benign prostatic hyperplasia (BPH) from prostate cancer. It is the discovery of the present invention that BPSA is preferentially elevated in transition zone prostate tissue whereas pPSA is elevated in the peripheral zone of prostate tissue. A kit for aiding in distinguishing BPH from prostate cancer is also provided.

Forms of free prostate-specific antigen (PSA) and their association with prostate tissues from prostate peripheral zone and transition zone

Monoclonal antibodies have been developed which specifically bind the PSA-ACT complex without significant cross-reactivity with PSA, ACT or CG-ACT. The antibodies were generated using a unique immunogen comprising a PSA-ACT complex having bound to monoclonal antibodies against PSA and monoclonal antibodies against ACT. It is theorized that the antibodies against PSA and ACT block immunodominant sites on the PSA-ACT complex. The antibodies generated against the unique immunogen specifically bind the PSA-ACT complex, but have no significant cross-reactivity with either PSA or ACT. The monoclonal antibodies of the present invention can be used in immunoassays to specifically detect PSA-ACT in a sample.

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Poway, CA, United States of America

Tang Jang Wang