The present invention relates to methods for identifying markers for systemic sclerosis (also scleroderma; SSc) and to the markers identified with the aid of this method, which can differentiate between SSc and other autoimmune diseases on the one hand and between different SSc subgroups on the other hand. The invention also relates to panels, diagnostic devices and test kits which comprise these markers, and to the use and application thereof, for example for the diagnosis, prognosis and therapy control of SSc. The invention also relates to methods for screening and for validating active substances for use in SSc.

The application provides a method of identifying or monitoring a plasma cell associated disease, comprising purifying immunoglobulin free light chains (FLCs) from a sample from a subject with anti-FLC specific antibodies or fragments thereof and subjecting the purified sample to a mass spectrometry technique to identify the presence of one or more peaks corresponding to one or more monoclonal FLCs in the sample.

Provided are methods of diagnosis and treatment of atopic dermatitis.

Methods, systems and kits for the early diagnosis or prediction of systemic inflammatory response syndrome (SIRS) including sepsis in asymptomatic patients, such as patients undergoing a surgical intervention, are provided. Some embodiments include a method and system for the detection or diagnosis of SIRS, or detection or diagnosis of a risk to suffer from or develop SIRS, in an asymptomatic patient comprising the steps of determining the level of IL-6 (or a variant thereof) in a sample from the patient; comparing the level of IL-6 (or a variant thereof) to a reference level; detecting or diagnosing SIRS or diagnosing a risk to suffer from or develop SIRS, wherein the sample is isolated at least 2 times at short intervals and the determining and comparing steps are both repeated for each sample. Also provided are methods, systems and kits for therapy monitoring and mortality prediction.

A diagnostically useful carrier includes a means for specifically capturing an antibody to a polypeptide from the group including squid MLC1 or squid MLC2 or a variant thereof in a sample from a subject. A method includes the step detecting in a sample from a subject the presence or absence of an antibody to squid MLC1 or squid MLC2. The polypeptide or the carrier or a polypeptide binding specifically to an IgE antibody from the sample of a patient to squid MLC1 or squid MLC2 are useful for the manufacture of a diagnostic kit, preferably for the diagnosis of allergy.

Provided are methods and compositions for labeling an allergen-specific pathogenic CD4+ T-cell. The method can comprise contacting a cell population comprising CD4+ T cells with a suspected allergen to provide a challenged cell population, contacting the challenged cell population, or a subpopulation thereof, with a first molecule that specifically binds to a biomarker for an allergen-specific pathogenic T cell, wherein binding of the first molecule to the biomarker on a CD4+ cell indicates the cell is an allergen-specific pathogenic CD4+ T cell, and detecting binding of the first molecule to a CD4+ cell, wherein binding to the cell indicates the cell is an allergen-specific pathogenic CD4+ T cell. The method is applicable to monitoring the presence of allergen-specific pathogenic CD4+ T cells and/or efficacy of immunotherapy for allergies in a subject.

The present invention provides isolated immune cells, immune cell populations and compositions, as well as markers, marker signatures and molecular targets characterising the immune cells. The cell products, substances, compositions, markers, marker signatures, molecular targets, kits of parts and methods of the present invention provide for new ways to characterise, evaluate and modulate the immune system and immune responses.

The present invention provides a novel milk allergy antigen, a milk allergy diagnosis method or diagnosis kit, a composition comprising the antigen, a milk or processed milk product with the antigen removed, and a tester composition for determining the presence or absence of the milk antigen in an object of interest. The present invention also pertains to an antigen epitope-comprising polypeptide, a kit for diagnosing an allergy comprising the polypeptide, diagnostic composition, a diagnosis method, a composition comprising the polypeptide, and a raw material or processed product in which the polypeptide-comprising antigen is eliminated or reduced. The present invention further pertains to a tester composition for determining the presence or absence of an antigen in an object of interest.

The invention provides methods and compositions for treating allergies that use antibodies or other products of the immune system from whom have already experienced and responded to an allergen. In particular, people who have suffered from an allergic reaction to an allergen but subsequently become desensitized to the allergen produce immune products that may be isolated or reproduced for use in a therapeutic composition.

This disclosure provides isolated or recombinant polypeptides that are useful to vaccinate individuals suffering from chronic/recurrent biofilm disease or as a therapeutic for those with an existing infection. The individual's immune system will then naturally generate antibodies which prevent or clear these bacteria from the host by interfering with the construction and or maintenance of a functional protective biofilm. Alternatively, antibodies to the polypeptides can be administered to treat or prevent infection. Bacteria that cannot form functional biofilms are more readily cleared by the remainder of the host's immune system and/or traditional antibiotics.