Abstract: The present invention provide reagents and methods of using the reagents, for example, on automated staining devices, that facilitate detection of two or more antigens in a sample simply and efficiently.

Abstract: The object of the present invention is to provide a cell that can exhibit physiological activity based on galectin-9, a method for producing the cell, and use of the cell. In order to achieve the above object, the cell of the present invention contains galectin-9, and the galectin-9 is expressed on a cell surface.

Abstract: Disclosed herein are isolated human monoclonal antibodies that specifically bind human CD22 with a dissociation constant (Kd) of 25 nM or less. Nucleic acids encoding these antibodies, expression vectors including these nucleic acid molecules, and isolated host cells that express the nucleic acid molecules are also disclosed. The antibodies can be used to detect human CD22 in a sample. In some cases, CD22 is soluble CD22. Methods of diagnosing a B-cell malignancy, or confirming a B-cell malignancy diagnosis, are disclosed herein that utilize these antibodies. Methods of treating a subject with a B-cell malignancy are also disclosed.

Abstract: Specific binding members, particularly antibodies and fragments thereof, which bind to HLA-B27 heavy-chain homodimers, termed HC-B27, HLA-B272 or B272, particularly recognizing B272 homodimers and which do not recognize or bind HLA-B27 heterotrimers (B27) including HLA-B27 heterotrimers with ?2 microglobulin and peptide. These antibodies are useful in the diagnosis and treatment of HLA-B27 mediated conditions, particularly those associated with B272, the spondylarthritides, a group of related diseases including ankylosing spondylitis (AS) and reactive arthritis (ReA or Reiter's syndrome). The antibodies, variable regions or CDR domain sequences thereof, and fragments thereof of the present invention may also be used in therapy in combination with chemotherapeutics, immune modulators, anti-inflammatory drugs, NSAIDs and/or with other antibodies or fragments thereof. Antibodies of this type are exemplified by the novel antibodies HD4, HD5 and HD6 whose sequences are provided herein.

Abstract: A method of diagnosing coeliac disease, or susceptibility to coeliac disease, in an individual comprising: (a) contacting a sample from the host with an agent selected from (i) the epitope comprising sequence which is: SEQ ID NO: 1 or 2, or an equivalent sequence from a naturally occurring homologue of the gliadin represented by SEQ ID NO: 3, (ii) an epitope comprising sequence comprising: SEQ ID NO: 1, or an equivalent sequence from a naturally occurring homologue of the gliadin represented by SEQ ID NO: 3, which epitope is an isolated oligopeptide derived from a gliadin protein, (iii) an analogue of (i) or (ii) which is capable of being recognised by a T cell receptor that recognises (i) or (ii), which in the case of a peptide analogue is not more than 50 amino acids in length, or (iv) a product comprising two or more agents as defined in (i), (ii) or (iii), and (b) determining in vitro whether T cells in the sample recognise the agent; recognition by the T cells indicating that the individual has, or is su

Abstract: The androgen receptor (AR) is the key driver of prostate differentiation and prostate cancer (PC) progression, and androgen ablation is the cornerstone of advanced PC treatment. Prostate-specific membrane antigen (PSMA) represents another target of interest in PC. Previous publications have reported inconsistent associations between androgen levels and PSMA expression. Using a panel of prototypical human PC cell lines, this relationship is clarified. PSMA is a biomarker that distinguishes AR-positive/PSMA-positive adenocarcinomas from AR-negative variants. PSMA is a cell surface barometer of androgen activity that can be readily identified by immunohistochemistry and/or in vivo imaging. Given that anti-androgen therapy is likely to remain a cornerstone of PC treatment, the associated up-regulation of PSMA, as well as its other characteristics, makes it a compelling target opportunity in PC.

Abstract: A protein structure capable of selective interaction with an organic target is provided. The protein structure is a polymer comprising as a repeating structural unit a recombinant fusion protein that is capable of selective interaction with the organic target. The fusion protein is comprising the moieties B, REP and CT, and optionally NT. B is a non-spidroin moiety of more than 30 amino acid residues, which provides the capacity of selective interaction with the organic target. REP is a moiety of from 70 to 300 amino acid residues and is derived from the repetitive fragment of a spider silk protein. CT is a moiety of from 70 to 120 amino acid residues and is derived from the C-terminal fragment of a spider silk protein. NT is an optional moiety of from 100 to 160 amino acid residues and is derived from the N-terminal fragment of a spider silk protein. The fusion protein and protein structure thereof is useful as an affinity medium and a cell scaffold material.

Abstract: The present invention relates to the discovery that VEGF, PlGF, and sFlt-1 levels are increased in inflammatory response such as in sepsis, severe sepsis, or septic shock. Additionally, the invention provides methods of identifying treatments as well as providing treatments for such an inflammatory response, which include decreasing VEGF or PlGF levels, or increasing sFlt-1 or PlGF levels.

Abstract: A new markers for insulin production decline in Type 1 diabetes has been found in the ratio the CD4 naïve (CD45RO-CD62L+) to central memory (CD45RO+CD62L+) and in the level of CD4 central memory T-cell subpopulations.

Abstract: A method for the transformation of material (e.g. plastic material) into an optically modulating state via laser radiation is described. The optically modulating state may be a state in which light is emitted at a different wavelength than it is absorbed. The plastic material to may be a thermoplastic or elastomeric material, or an organic polymer selected from the group consisting of polyethylene, polypropylene, polystyrene, polycarbonate and polycycloolefin. The laser radiation may comprise the application of an amount of energy of about 0.1 nJoule/?m2 to about 100 ?Joule/?m2 and/or may comprise a radiation of a wavelength of about 355 nm to about 1064 nm. The optically modulating state of the plastic material may absorb light in a wavelength spectrum of about 380 nm to about 540 nm and/or a wavelength spectrum of about 635 nm to about 655 nm. The optically modulating state of the plastic material may emit light in a wavelength spectrum of about 550 nm to about 800 nm.

Abstract: A complex comprising a Class II HLA-DRB1*03 or Class II HLA-DRB1*13 molecule bound to a peptide, wherein the peptide comprises the amino acid sequence HTYTIDWTKDAVTWS or a portion thereof, or a variant of the given amino acid sequence or portion wherein the side chains of one or two or three or four or five or six or seven of the amino acid residues are altered, wherein the peptide comprising the portion, or variant, is capable of binding HLA-DRB1*03 and/or HLA-DRB1*13. The complex may be used to select Aspergillus and Candida antigen-specific T cells.

Abstract: The present invention relates to polynucleotide markers and protein markers for detecting human follicular helper T cells. The present invention also relates to methods for detecting human follicular helper T cells using the markers.

Abstract: The present invention provides methods of making engineered viral proteins and protein complexes that are useful as vaccine immunogens, engineered viral proteins and protein complexes made using such methods, and pharmaceutical compositions comprising such engineered viral proteins and protein complexes. Such engineered viral proteins and protein complexes may comprise one or more cross-links that stabilize the conformation of an antibody epitope, such as a quaternary neutralizing antibody, and may exhibit an enhanced ability to elicit a protective immune response when administered to a subject as a component of a vaccine.

Abstract: The interface between nanotechnology and biological systems is used to synthetically replicate the body's vital, innate, immune functions with targeted precision. Through the creation and use of complexed nanodiamonds (or other particles) with capture agents in a flow-through return apparatus or in an analytic/diagnostic tool, the invention provides individualized treatment of blood-borne pathogens and disease spectrums and rapid, individualized diagnostics. The invention can be used, for example, to clear blood-borne pathogens during initial infections prior to tissue sequestration in real time, to decrease overwhelming numbers of bacterial/viral/cytokine load during life threatening infectious conditions, to super sensitize the immune system to a variety of conditions-cancer markers, vaccinates, etc.

Abstract: The invention relates to a specialized subpopulation of natural killer cells that have enhanced effector functions and the potential to kill malignant tumor cells or infected cells when the natural killer cells are exposed to an antibody bound to the tumor cells or the infected cells.

Abstract: This disclosure relates to methods and devices to count particles of interest, such as cells. The methods include obtaining a fluid sample that may contain particles of interest; counting all types of particles in a portion of the sample using a first electrical differential counter to generate a first total; removing any particles of interest from the portion of the fluid sample; counting any particles remaining in the portion of the fluid sample using a second electrical differential counter after the particles of interest are removed to generate a second total; and calculating a number of particles of interest originally in the fluid sample by subtracting the second total from the first total, wherein the difference is the number of particles of interest in the sample. These methods and related devices can be used, for example, to produce a robust, inexpensive diagnostic kit for CD4+ T cell counting in whole blood samples.

Abstract: The present invention relates to methods of enriching fetal cells from a pregnant female. The present invention relates to removing, from a sample, cells that comprise at least one MHC molecule. The present invention also relates to methods that rely on using telomerase, mRNA encoding components thereof, as well as telomere length, as markers for fetal cells. Enriched fetal cells can be used in a variety of procedures including, detection of a trait of interest such as a disease trait, or a genetic predisposition thereto, gender typing and parentage testing.

Abstract: The present invention relates to compositions for preventing or treating allergy to ragweed by tolerisation. The compositions are based on combinations of peptide fragments derived from the major allergen in ragweed pollen, Amb a 1. The invention also relates to products, vectors and formulations which may be used to provide polypeptides of the invention in combination. The invention further relates to in vitro methods for determining whether T cells recognize a polypeptide of the invention, and for determining whether an individual has or is at risk of a condition characterized by allergic symptoms in response to a ragweed allergen.

Abstract: Ghrelin signal peptide fragment assays and kits useful in the diagnosis, prognosis, risk stratification, assessing, staging, monitoring, categorizing and determination of further diagnoses and treatment regimens in subjects with various disorders, diseases and conditions including, pneumonia, heart failure, or pneumonia and heart failure or suspected pneumonia, heart failure, or pneumonia and heart failure, and methods for monitoring treatment.

Abstract: The present invention generally provides methods and systems for performing in vivo flow cytometry by using blood vessels as flow chambers through which flowing cells can be monitored in a live subject in vivo without the need for withdrawing a blood sample. In some embodiments, one or more blood vessels are illuminated with radiation so as to cause a multi-photon excitation of an exogenous fluorophore that was previously introduced into the subject to label one or more cell types of interest. In some other embodiments, rather than utilizing an exogenous fluorophore, endogenous (intrinsic) cellular fluorescence can be employed for in vivo flow cytometry. The emission of fluorescence radiation from such fluorophores in response to the excitation can be detected and analyzed to obtain information regarding a cell type of interest.

Abstract: The present invention relates generally to the field of generating fusion proteins to be used in cancer therapy, and more specifically, to nucleotide sequences encoding the fusion proteins, wherein the chimeric fusion proteins comprises at least one targeting moiety and at least one immunomodulatory moiety that counteracts the immune tolerance of cancer cells.

Abstract: The invention discloses a method of prenatal diagnosis comprising the step of isolating exosomes from an isolated fluid, wherein the exosomes are identified by biomarker detection. Furthermore, the invention discloses the isolation of exosomes from an isolated fluid and the use of a biomarker, particularly CD24 to isolate exosomes from an isolated fluid.

Abstract: The disclosed methods use a multi-phase system to separate samples according to the density of an analyte of interest. The method uses a multi-phase system that comprises two or more phase-separated solutions and a phase component such as a surfactant or polymer. The density of the analyte of interest differs from the densities of the rest of the sample. The density of the analyte of interest is substantially the same as one or more phases. Thus, when the sample is introduced to the multi-phase system, the analyte of interest migrates to the phase having the same density as the analyte of interest, passing through one or more phases sequentially.

Abstract: The invention pertains to a method for the determination of basophil activation induced by a test substance by flow cytometric measurement of the changes of the mean or median fluorescence intensities (MFI) of the basophilic Fc?RI receptor present on the cell surface of basophils (MFI-Fc?RI) and/or the IgE antibodies bound to the Fc?RI receptor (MFI-IgE), and the CD63 antigen exposed on the cell surface of basophils after their activation (MFI-CD63), by means of a mixture of anti-CD63, anti-Fc?RI or anti-IgE, and anti-CCR3 antibodies each labelled with a distinct fluorophore, of which at least one antibody acts as a basophil selection marker and at least two antibodies act as basophil activation markers, and bringing the mean fluorescence intensities of the activation markers in correlation to obtain an Activation Index.

Abstract: Devices and methods for performing a point of care blood, cell, and/or pathogen count or a similar blood test. Disclosed herein are systems that can be used to provide rapid, accurate, affordable laboratory-quality testing at the point of care. The systems described herein are capable of imaging and counting individual cells in a prepared cell sample (e.g., a peripheral blood smear or a blood sample prepared in a microfluidic device) or another prepared cell-containing sample without the need for a microscope or other expensive and cumbersome optics. The systems described herein are designed to eliminate or replace expensive, centralized clinical testing equipment and technical personnel. Such systems may include automated data reporting and decision support.

Abstract: The invention relates to purinergic (P2X) receptors, more specifically to P2X7 receptors, the generation of antibodies and the use of antibodies and immunogens that are capable of selectively binding to a non ATP-binding P2X7 receptor but not to an ATP-binding P2X7 receptor, for the detection and treatment of disease conditions, especially cancer.

Abstract: This invention relates to vaccine formulations comprising the Yersinia pestis YopE peptide antigen or subparts thereof. The invention also relates to methods of vaccinating subjects at risk of Yersinia pestis infection as well as assays for measuring immune response to plague vaccines.

Abstract: Endothelial cells are detected in a blood sample by enriching the endothelial cells from the blood sample followed by performing on the enriched endothelial cells an immunoassay capable of detecting antigens expressed by the endothelial cells. The immunoassay is capable of detecting antigen expressed from 300 endothelial cells per milliliter of blood. The method can be used for assaying mature circulating endothelial cells or circulating endothelial progenitor cells.

Abstract: The present invention relates specific activation of a regulatory T cell via a specific CD4 epitope and uses thereof, e.g. for the treatment of an autoimmune disease or an allergy or asthma or graft rejection or tolerance induction.

Abstract: A method of screening biologically active agent based on the analysis of complex biological responses in culture. Methods for selecting cells and culture conditions for such screens are provided, as well as the identification of an optimized set of discrete parameters to be measured, and the use of biomap analysis for rapid identification and characterization of drug candidates, genetic sequences acting pathways, and the like. A feature of the invention is simultaneous screening of a large number of cellular pathways, and the rapid identification of compounds that cause cellular responses.

Abstract: A method for determining the risk for developing a scoliosis comprising monitoring osteopontin (OPN) expression in a sample from a subject over time; wherein an OPN expression that increases in the subject sample over time is indicative that the subject is at risk for developing a scoliosis.

Abstract: The present invention relates to a marker allowing specific detection of human IL-17-producing helper T-cells (human Th17 cells), a method for specifically detecting human Th17 cells and a reagent for detecting human Th17 cells.

Abstract: The invention relates to the diagnosis, prognosis, monitoring, and treatment of neoplastic diseases such as tumor diseases, especially tumor diseases of the endometrium and the metastases thereof.

Abstract: This invention relates to a novel target for production of immune and non-immune based therapeutics and for disease diagnosis. More particularly, the invention provides therapeutic antibodies against TMEM154 antigens, which are differentially expressed in cancer, and diagnostic and therapeutic usages, wherein the cancer is relates to multiple myeloma, including multiple myeloma precursor diseases. This invention further relates to extracellular domains of TMEM154 proteins and variants, and therapeutic usages thereof.

Abstract: A method is described for the diagnosis and/or monitoring of active or previous infection by Mucor which consists in the identification of Mucorales-specific T cells in samples from biological fluids taken from the patient and put into contact with a Mucor antigen. These specific immune responses can be detected by the execution of immunoenzymatic assays (ELISPOT, Quantiferon) or of immunocytofluorimetric assays [Cytokine Secretion Assay (CSA), Intracellular Cytokine Staining (ICS)] in vitro. In greater detail, the method in question provides for checking for the presence of specific IFN-? producing T cells, of specific IL-10 producing T cells and/or specific IL-4 producing T cells.

Abstract: The invention relates to a method for the diagnosis and/or prognosis of inflammatory states.

Abstract: The invention describes new peptides containing epitopes recognized by CD4+ natural killer T (NKT) cells for increasing activity for use in infectious diseases, autoimmune diseases, immune reaction to administration of allofactors, allergic diseases, therapy of tumors, prevention of graft rejection and prevention of immunization against viral proteins used in gene therapy or gene vaccination.

Abstract: An embodiment relates to a method of detecting a drug resistance in a patient comprising adding nanoparticles to sample platelets to form activated platelets containing the nanoparticles and comparing a difference in activation of the activated platelets and the sample platelets. Another embodiment relates to a method of monitoring a thrombotic risk factor in a subject in a general population comprising adding nanoparticles to sample platelets to form activated platelets containing the nanoparticles and comparing a difference in activation of the activated platelets and the sample platelets. Yet another embodiment relates to a kit comprising nanoparticles, a fluorescence dye tagged antibody and optionally a buffer, wherein the kit is configured to detect a drug resistance in a patient or a likelihood of the thrombotic risk factor in a subject in general population.

Abstract: The invention is based on the discovery that interleukin-1 alpha (IL-1alpha) is expressed on the proinflammatory CD14+CD16+ monocyte subset. Importantly, since IL-1alpha appears to be almost exclusively expressed on this monocyte subset and not other leukocytes, it represents an ideal marker for targeting the CD14+CD16+ monocyte subset. The effectiveness of an agent that depletes such pathogenic cells or modulates IL-1alpha function on such cells type can be monitored by assessing CD14+CD16+ monocyte levels or functionality.

Abstract: The methods of the disclosure provide fluorescence-based assays for calcineurin activity, especially in isolated T cells. The methods include the stimulation of the T cells with agents that specifically target the TCR with or without influencing co-stimulatory pathways. One TCR agonist is monoclonal antibodies specific for CD3, which more precisely distinguish the inducible activity of calcineurin than does an alternative method targeting the T cell receptor (CD3) combined with CD28 costimulation. This method more accurately distinguishes between the measured level of calcineurin activity of T cells from immunosuppressed transplant recipients and normal individuals, and thus has improved diagnostic accuracy with respect to the response of an individual to immunosuppressant therapy following an organ transplant.

Abstract: The present invention refers to the use of gene sequences or portions thereof characterized in that the same belong to the classes of in vitro and ex vivo induced, repressed or conserved genes in Mycobacterium tuberculosis currently infected human macrophages and to corresponding peptides or consensus peptides or proteins for the preparation of specific bio-markers for the diagnosis and prevention of active or latent disease.

Abstract: The present disclosure provides anti-CXCR3 antibodies and methods of using the antibodies to diagnose and/or treat CXCR3-associated disorders such as diabetes mellitus type I (T1D), particularly new-onset T1D. In certain embodiments, disclosed herein are CXCR3 neutralizing antibodies.

Abstract: A method for the diagnosis and/or prognosis of inflammatory states, and the use of at least one soluble receptor-binding (RBD), for the identification and quantication of the expression of membrane receptors present on the surface of target granulocytes, said identification and quantification taking place at a given time or during a given time interval, and allowing the diagnosis and/or prognosis of inflammatory states in a mammal.

Abstract: Inflammatory state in a subject is assayed by determining the level of expression of A3 adenosine receptor (A3AR) in white blood cells (WBC), e.g. circulating WBCs, from the subject. A high level of expression of A3AR is indicative of an inflammatory state in the subject. This assay can be used for determining the severity of inflammation in a subject and monitoring the efficacy of anti-inflammatory treatment. Also, the level of expression may be used for selecting patients to receive an anti-inflammatory treatment that comprises an A3AR agonist.

Abstract: The inventions relates to compositions and method for determining the absolute counts of cells per unit volume of a sample. Such a method comprises: (a) providing a container containing (i) a predetermined quantity of microparticles; and (ii) a cell-binding agent; in which the microparticles are disposed in or on a matrix which adheres to at least one wall of the container such that substantially all the microparticles are thereby attached to the container; (b) adding a known volume of sample to the container; (c) determining the ratio of microparticles to cells by counting microparticles and cells in a volume of the sample; and (d) determining the absolute count of cells by multiplying the number of cells per microparticle by the concentration of microparticles in the sample.

Abstract: This present invention provides a method of predicting immunogenicity and hypersensitivity or allergic reactions to chemical compounds, therapeutics, cosmetics and other chemical compositions. The method uses an in vitroassay employing autologous bloodderived cells and an autologous cultured skin biopsy and is of particular utility in the identification and prediction of skin sensitizers that cause allergic contact dermatitis.

Abstract: A system and method for determining the presence and/or concentration of one or more analytes in a sample that comprises a fluid, the system comprising a solid substrate comprising a sample inlet or inlets and one or more analyte determination flow paths, each analyte determination flow path comprising a defined beginning and a defined terminus and comprising at least one capture zone containing a capture agent for an analyte, the capture agent or agents being immobilized along a portion of the flow path or paths, the flow path or paths being designed so that the one or more analytes are depleted from the sample and bound in a non-linear manner to the portion of the flow path or paths containing immobilized capture agent or agents, producing an analyte depletion end region for each analyte between the beginning and the terminus of the analyte determination flow path.

Abstract: The invention described herein provides a method for screening pathogenic viral envelope proteins and protein complexes to identify protein constructs with enhanced effectiveness as vaccine immunogens. The method is carried out by (i) expressing of a membrane-bound isotype of an antibody that has the same binding activity and specificity of an antibody that is known, or identified, to bind and neutralize the targeted virus, and that has the capacity to activate signaling pathways down-stream of B cell receptor ligand binding and activation—a modified neutralizing antibody-based B cell receptor; (ii) exposing the cell to antigen; and (iii) assay for signaling downstream of B cell receptor activation. The present invention also provides the antigens identified using the as say described herein, and neutralizing antibodies derived by immunization with the antigens identified using the assay described herein.

Abstract: The present invention provides methods for early diagnosis of amyotrophic lateral sclerosis (ALS) and for determining the efficacy of a treatment for ALS in an ALS patient, i.e., monitoring ALS progression, utilizing cellular blood markers; as well as kits for carrying out these methods.

Abstract: Methods for identifying subjects having a cancer or pre-malignant condition that will benefit from anti-CD40 therapeutic agents that modulate CD40L-mediated CD40 signaling are provided. The methods comprise the use of biomarkers of cellular apoptosis, cell proliferation and survival, and CD40 signaling pathways to monitor ex vivo response to one or more anti-CD40 therapeutic agents of interest that modulate CD40 signaling on CD40-expressing neoplastic cells. The ex vivo prognostic assays can be used alone or in conjunction with other prognostic assays to identify candidate subjects who will benefit from treatment with anti-CD40 therapeutic agents. Methods of the invention also comprise the use of these biomarkers to monitor in vivo efficacy of treatment with an anti-CD40 therapeutic agent.