The invention provides a method for inducing human primordial germ cell-like (PGC-like) cells from human pluripotent stem cells, with high efficiency and high reproducibility, and a cell surface marker for identifying human PGC-like cells. In particular, the invention provides a method for producing a human PGC-like cell from a human pluripotent stem cell, includes a step of producing a mesoderm-like cell by culturing a human pluripotent stem cell in a culture medium comprising activin A and a GSK3 inhibitor, and a step of culturing the mesoderm-like cell in a culture medium containing BMP. The invention also provides a method for producing an isolated human PGC-like cell, which includes the aforementioned two steps and the additional step of selecting a cell positive to at least one cell surface marker selected from the group consisting of PECAM (CD31), INTEGRINa6 (CD49f), INTEGRIN3 (CD61), KIT (CD117), EpCAM, PODOPLANIN and TRA1-81.

The present invention relates to compositions and methods for visualizing disease-specific T-cells. In particular, the present invention relates to compositions and methods for use in the diagnosis, monitoring of progression, monitoring of response to therapy, and selection of patients for therapy of autoimmune diseases characterized by selective expansion of disease-specific effector memory T-cells.

A method of diagnosing a cancer or a pre-malignant lesion is disclosed. The method comprising determining a level of expression of CD24 on leukocytes comprised in a biological sample of a subject, wherein a level of CD24 on small leukocytes and not on large leukocytes above a predetermined threshold is indicative of the cancer or the pre-malignant lesion. A method of monitoring efficacy of cancer therapy and a kit for diagnosing a cancer or a pre-malignant lesion are also disclosed.

The present invention provides methods for the identification of an antigen receptor (e.g., an antibody) that specifically binds to an antigen of interest. Generally, this involves contacting a plurality of antigen receptor-expressing cells with an antigen of interest; measuring the level of activated adhesion molecules on the surface of the antigen receptor-expressing cells; and, identifying from the plurality of antigen receptor-expressing cells an antigen receptor-expressing cell that exhibits an increased amount of activated adhesion molecules on the cell surface.

The invention relates to in vitro or ex vivo methods for assessing the cognitive function of a subject in the context of the prevention of neurodegenerative diseases. A particular method comprises a step of associating a subject to a cognitive status selected from healthy cognitive status, Subjective Cognitive Impairment, Mild Cognitive Impairment and neurodegenerative disease, and the association of cognitive status results from the evaluation of glycosylated MCSF and CCR2 expressed at the surface of PBMC in a biological sample from the subject. The present invention also provides kits suitable for implementing such methods.

The present invention provides a sensitive and specific indirect homogeneous mobility shift assay using size exclusion chromatography to measure biologics such as vedolizumab and ustekinumab in a patient sample. The assays of the present invention are particularly advantageous for detecting the presence or level of biologics that target complex or large antigens including cell surface proteins, transmembrane proteins, heavily glycosylated proteins, and multimeric proteins, as well as antigens that cannot be purified, impure antigens, and partially or substantially purified antigens. The present invention also provides isolated soluble 47 integrin heterodimers and isolated soluble IL-12p40 monomers that are suitable for use in the indirect assays described herein.

Methods and apparatus for assaying the level of analytes in a sample, related to VLA-4, are disclosed. A method of decreasing the level of an anti-integrin antibody in a subject is described including a) contacting a biological sample from a subject with a detectable capture agent associated with a substrate, wherein the capture agent can bind an anti-integrin antibody in the sample; b) detecting binding of the capture agent with the level of the anti-integrin antibody; and c) treating the subject with plasma exchange until the level of the anti-integrin antibody in the sample reaches a predetermined level.

Cell surface Raman spectroscopy and a quantitative measure of cell surface integrin from monocytes isolated from peripheral blood provide a measure of active inflammation. Patients with elevated lipid profiles and inflammatory status are at high risk for plaque producing atherosclerosis and candidates for aggressive treatment and clinical follow-up.

The invention provides a method for inducing human primordial germ cell-like (PGC-like) cells from human pluripotent stem cells, with high efficiency and high reproducibility, and a cell surface marker for identifying human PGC-like cells. In particular, the invention provides a method for producing a human PGC-like cell from a human pluripotent stem cell, includes a step of producing a mesoderm-like cell by culturing a human pluripotent stem cell in a culture medium comprising activin A and a GSK3 inhibitor, and a step of culturing the mesoderm-like cell in a culture medium containing BMP. The invention also provides a method for producing an isolated human PGC-like cell, which includes the aforementioned two steps and the additional step of selecting a cell positive to at least one cell surface marker selected from the group consisting of PECAM (CD31), INTEGRIN6 (CD49f), INTEGRIN3 (CD61), KIT (CD117), EpCAM, PODOPLANIN and TRA1-81.

A method for treating a human patient suffering from fistulizing Crohn's disease, comprising administering to a patient suffering from fistulizing Crohn's disease, a humanized antibody having binding specificity for human 47 integrin, wherein the human patient has a seton that was surgically placed prior to administration of the antibody, and wherein the dosing regimen induces fistula(e) healing.