Hybritech Incorporated

Biocept, Inc.

Other

Mayo Foundation for Medical Education and Research

Beckman Coulter, Inc.

Hyrbritech Incorporated

Baylor College of Medicine

Stephen D Mikolajczyk

Pavel Tsinberg

Mohammad Saeed Saedi

Harry G Rittenhouse

Robert L Wolfert

Tony Pircher

Farideh Z Bischoff

Tang Jang Wang

Kevin Slawin

Abhay Kumar

Donald J Tindall

Charles Y Young

Kristine Kuus-Reichel

Lisa S Millar

The present invention provides a device for isolating target biomolecules or cells from samples, particularly biological samples. In particular, the device comprises a loading mixture, which contains the biological sample and a first binding entity that specifically binds to the target biomolecule or target cell; and a micro-channel coated with a second binding entity that binds directly or indirectly to the first binding entity. Methods of capturing, detecting, and/or evaluating target biomolecules or target cells (e.g. cancer cells) in biological samples are also disclosed.

Devices and methods of cell capture and analysis

The present invention provides reagents containing binding moieties conjugated to dextran moieties, methods of making such reagents, and use of such reagents in a variety of molecular and cellular assays.

Methods and reagents for signal amplification

The present invention provides methods for preventing clumping of cells in microfluidic devices by addition of diazolidinyl urea (DU). DU can be added to samples at the time of collection or can be added to samples post-collection. DU can also be pre-added to sample collection devices.

Use of diazolidinyl urea for anti-clumping of biological samples

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

Assays for detecting and determining the presence of prostate cancer is provided. The assays are capable of detecting prostate cancer in the population of men with a significantly higher ratio of free PSA to total PSA. The assays are also capable of detecting prostate cancer in the population of men with a low amount of total PSA, i.e., in the range of 2 to 4 ng/ml. In accordance with one embodiment of the present invention, the assay includes the steps of (a) determining the amount of total PSA contained in a biological sample from the patient, (b) determining the amount of free PSA in the sample; and calculating the ratio of the free PSA to the total PSA, (c) determining the amount of pPSA in the sample, (d) determining the amount of BPSA in the sample, (e) determining the amount of inPSA in the sample, and (f) correlating the amount of inPSA contained in the sample to the presence of prostate cancer in the patient by comparing the amount of inPSA to a predetermined value established with control samples of known cancer and benign disease diagnosis, based on both the level of total PSA and the % free PSA.

Method of analyzing non-complexed forms of prostate specific antigen in a sample to improve prostate cancer detection

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

The present invention provides a novel complex of hK2 and PI-6 and methods of using the novel complex and its constituents. The novel complexes of hK2 and PI-6 of the present invention and the PI-6 exist at an elevated level in prostate cancer tissues. PI-6 also exists at an elevated level in other types of cancer cells. Therefore, the hK2-PI6 complexes and PI-6 of the present invention may be used as a serum marker for detecting cancers, particularly prostate cancer. They may also be used as an immunohistological marker to detect prostate cancer tissues. In accordance with the present invention, the hK2-PI6 complexes of the present invention may be detected in patient tissue samples by immunohistochemical and/or in patient fluid samples by in vitro immunoassay procedures. Diagnostic methods for detecting the existence of prostate cancer is also provided.

Complex of human kallikrein 2 (hK2) and protease inhibitor-6 (PI-6) in prostate tumor tissue and methods of using the complex and its constituents

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

The present invention provides a novel complex of hK2 and PI-6 and methods of using the novel complex. The novel complexes of hK2 and PI-6 of the present invention exist at an elevated level in prostate cancer tissues. Therefore, the hK2-PI6 complexes of the present invention may be used as a serum marker for detecting prostate cancer. They may also be used as an immunohistological marker to detect prostate cancer tissues. In accordance with the present invention, the hK2-PI6 complexes of the present invention may be detected in patient tissue samples by immunohistochemical and/or in patient fluid samples by in vitro immunoassay procedures. Diagnostic kits and diagnostic methods for detecting the existence of prostate cancer are also provided.

Complex of human kallikrein 2 (hK2) and protease inhibitor-6 (PI-6) in prostate tumor tissue and methods of using the complex

An isolated, purified variant hK2 polypeptide useful in preparing immunogenic compositions and vaccines is provided. The variant hK2 polypeptides are more stable to purification than wild type mature hK2 polypeptide.

Stable variant hK2 polypeptide

An isolated, substantially homogenous pre-pro, pro or mature hK2 polypeptide is provided as well as biologically active variants or subunits thereof, including a biologically active variant pre-pro hK2 polypeptide having SEQ ID NO:19.

Growing community of inventors

San Diego, CA, United States of America

Stephen D Mikolajczyk