Methods, kits, and diagnostic devices are disclosed for diagnosing an invasive fungal infection in a subject by measuring a T-cell interferon gamma (IFN-) response after exposure to a fungal antigen.

The present invention relates to methods for the identification of clinical risk in patients having, or suspected of having, influenza. The invention also relates to methods for distinguishing between patients having influenza or viral pneumonia from patients having a symptomatically similar condition. The methods of the invention comprise determination of the level of expression of interferon alpha inducible protein 27 (IFI27) in a biological sample from a patient having, or suspected of having, influenza. Kits comprising suitable components for the performance of the methods are also provided by the invention. The invention allows stratification of patients into groups defining clinical risk, for example groups based on the severity of risk to the long-term health of the subject.

The present invention includes a composition and a method of modulating an immune response with a composition that comprises an anti-BAFF receptor antibody or binding fragment thereof that is bound or conjugated to an siRNA, and shRNA, or both, that targets a BAFF receptor mRNA.

A system and method determines one or more favorable dates for delivery of therapeutic treatment to a specific patient based on the state of one or more biological variables of the patient on the proposed treatment date(s). The state of the biological variables refers to whether the concentration of the biological variable is greater than a threshold value (state=HIGH or UP) on the proposed date of treatment or less than a threshold value (state=LOW or DOWN) on the proposed date of treatment. The biological variables may include lymphocytes and/or monocytes. A system and method may also determine one or more favorable dates for delivery of therapeutic treatment to patient based on a lymphocyte-to-monocyte ratio on the proposed treatment dates, and/or the state of the lymphocytes and monocytes on the proposed treatment dates.

Disclosed herein are methods in which an individual with multiple sclerosis (MS) can be classified into one of six subject groups, each subject group predictive for the patient's responsiveness to an interferon- (IFN-) therapy. The individual with MS can be classified according to the individual's serum marker levels, e.g., at baseline or following treatment with therapy. Depending on the classification, the individual with MS can be treated with standard therapies (e.g. IFN-) or one or more alternative therapies with or without IFN-.

The present invention relates to means and methods for determining whether a patient is in need of a PD-L1 inhibitor cotherapy. A patient is determined to be in need of the PD-L1 inhibitor cotherapy if a low or absent ER expression level and an expression level of programmed death ligand 1 (PD-L1) that is increased in comparison to a control is measured in vitro in a sample from the patient. The patient is undergoing therapy comprising a modulator of the HER2/neu (ErbB2) signaling pathway (like Trastuzumab) and a chemotherapeutic agent (like dodetaxel) or such a therapy is contemplated for the patient. Also provided herein are means and methods for treating a cancer in a cancer patient for whom therapy comprising a modulator of the HER2/neu (ErbB2) signaling pathway (like Trastuzumab) and a chemotherapeutic agent (like dodetaxel) is contemplated, wherein the patient is to receive PD-L1 inhibitor cotherapy.

The invention provides a method for predicting whether a binding peptide, which binds to a target peptide presented by a Major Histocompatibility Complex (MHC) and is for administration to a subject, has the potential to cross react with another peptide in the subject in vivo. The method comprises the steps of identifying at least one binding motif in the target peptide to which the binding peptide binds; and searching for peptides that are present in the subject that comprise the at least one binding motif and that are not the target peptide. The presence of one or more such peptides indicates that the binding peptide has the potential to cross react in vivo.

The present invention provides novel processes, compositions, and methods for analyzing or assaying the potency and/or functionality of tumor infiltrating lymphocyte (TIL) products for use in therapy, including human cancer therapy, and analyzing or assaying the potency and/or functionality of other polyclonal products, such as marrow infiltrating lymphocyte (MIL) and peripheral blood lymphocyte (PBL) products. Compositions, methods, and kits for preparing and treating cancer using TIL, MIL, and PBL products are also provided.

The present invention relates to an information provision method for examining active immunity. The present invention comprises (a) preparing a plurality of biological samples; (b) preparing a first reagent containing a vaccine antigen against SARS-CoV-2 or a protein antigen expressed by the vaccine, and a second reagent containing a protein derived from SARS-CoV-2 other than the antigen contained in the first reagent; c) preparing a plurality of mixed samples by mixing the biological samples with the reagents; d) preparing a plurality of detection reagents including a conjugate containing a signal generating means and an anti-interferon gamma antibody; (e) preparing a plurality of analyte samples by adding the detection reagent to the mixed sample; and (f) loading the analyte samples into a plurality of lateral flow cartridges and measuring signals from the cartridges using a signal detector.

The present invention relates to a method of simultaneously diagnosing active tuberculosis and latent tuberculosis infection (LTBI) using one or more biomarkers selected from a white blood cell count, a hemoglobin concentration, a neutrophil count, a lymphocyte count, a monocyte count, a procalcitonin concentration, a C-reactive protein concentration, an ?1-acid glycoprotein concentration and an erythrocyte sedimentation rate, or a combination thereof. The present invention may provide a diagnostic method for simultaneously differentiating active tuberculosis and LTBI without a separate additional test on a patient diagnosed as positive by a conventional tuberculosis infection assay such as a tuberculin skin test (TST) or an interferon-T release assay (IGRA).