The present disclosure relates generally to biomarkers and peptide arrays, and, more particularly, to a method of using a peptide array to identify biomarkers for an autoimmune disease such as, e.g., Celiac disease. Furthermore, a set of novel biomarkers for Celiac disease, having high sensitivity and specificity, are disclosed in addition to method of treatment using the novel biomarkers.

The present invention provides novel antigens of an allergy to fish, methods and kits for diagnosing an allergy to fish, pharmaceutical compositions comprising such an antigen, fishes, fish eggs or processed products of such fish or fish egg in which such an antigen is eliminated, fishes that deliver such fish eggs or are born from such fish egg, and a tester for determining the presence or absence of a fish antigen in an object of interest. The present invention also relates to polypeptides comprising an epitope of an antigen, kits, compositions and methods for diagnosing an allergy, comprising such a polypeptide, pharmaceutical compositions comprising such a polypeptide, and raw materials or processed products in which an antigen comprising such a polypeptide is eliminated or reduced. The present invention further relates to a tester for determining the presence or absence of an antigen in an object of interest.

A method is described for using live mesenchymal stromal cells (MSCs) in a way which allows for identification of patients likely to respond to immunosuppressive treatment using MSCs. The method involves contacting a sample from said patient with live MSCs in vitro, and determining whether the sample is able to induce at least some apoptosis to occur in live MSCs in vitro, or detection of elevated levels of prostaglandin E2 (PGE2). The ability of the sample to induce said apoptosis and/or elevated levels of PGE2 is indicative of responsiveness of said patient to said immunosuppressive treatment and/or indicative of fitness to recover. Also provided are apoptotic MSCs for use in the treatment of immune-mediated disease or conditions, such as allo-immune or autoimmune disease, or for the prevention or treatment of rejection of a transplanted organ; or in regenerative medicine to stimulate tissue repair. Methods for preparing pharmaceutical compositions comprising the apoptotic MSCs are also described and claimed.

Provided herein are methods, assays and devices for the detection and diagnosis of autoimmune diseases, including systemic lupus erythematosus. The methods, assays and devices provided herein analyzes binding patterns of peripheral-blood antibodies on peptide array that correlates well with current systemic lupus erythematosus clinical assessment standards.

The present invention provides methods, assays and kits for assessment of patients positive for SARS-CoV-2 infection and methods of diagnosis and treatment of COVID-19 disease and for assessment and evaluation of individuals prior to vaccination with live attenuated virus vaccines, particularly including yellow fever vaccines and COVID-19 vaccines, to assess risk for vaccine-associated disease and adverse events, and for evaluation, treatment and management of patients who develop vaccine-associated disease. The invention provides methods and assays for identification and characterization of inborn errors of type I interferon immunity and also auto-antibodies against Type I IFNs that are associated with severe COVID-19 disease or that are correlated and linked with vaccine-associated disease. The invention further provides methods of diagnosing and determining altered response to or susceptibility to SARS-CoV-2 infection or to live attenuated virus vaccines and for applicable and suitable treatment of COVID-19 disease or vaccine-associated disease.

The present disclosure is directed to methods and compositions for the prediction and treatment of immunotherapy-induced toxicities, as well as improved methods for the treatment of cancer with immunotherapies.

The present disclosure relates to the identification and use of biomarkers (e.g., analytes, analyte profiles, or markers (e.g., gene expression and/or protein expression profiles)) with clinical relevance to cytokine release syndrome (CRS).

The invention relates to allergic disease, to the development of allergic disease in infants, to determining the likelihood of development of allergic disease in infants and to minimizing the likelihood of development of allergic disease in infants.

Provided herein are methods, assays and devices for the differential diagnosis and detection of disease progression of autoimmune diseases. The methods, assays and devices provided herein produce and analyze binding patterns of peripheral-blood antibodies on mimetic peptide arrays that differentiate autoimmune diseases, and identify patients progressing to internal organ complications such as interstitial lung disease (ILD), and gastric antral vascular ectasia (GAVE), or renal involvement.

A soluble N-methyl-D-aspartate receptor (NMDAR) protein construct includes one or more NMDAR autoantibody epitopes. The construct includes an extracellular domain (ECD) of the NMDAR subunit GluN1 or a fragment of the subunit and an ECD of at least one of the NMDAR subunits GluN2A, GluN2B, GluN2C or GluN2D, or fragment of these subunits. An in vitro method for the detection of NMDAR autoantibodies in a sample includes providing a sample suspected of including NMDAR autoantibodies, providing the NMDAR protein construct as a capture molecule, contacting the sample with the NMDAR protein construct, thereby binding NMDAR autoantibodies from the sample to the NMDAR protein construct, and determining the presence and optionally the amount of bound NMDAR autoantibodies. The method is applied for the diagnosis, prognosis, disease monitoring, patient stratification and/or therapy monitoring of a medical condition associated with autoantibodies against the NMDAR, preferably anti-NMDAR encephalitis.