The present invention relates to methods and compositions for diagnosing and enabling treatment of chronic kidney disease in a feline. In one embodiment, a method of diagnosing chronic kidney disease (CKD) in a feline can comprise measuring a normalized relative abundance or absolute quantification of a first serum biomarker and determining if the feline has CKD, early-stage CKD, or late-stage CKD based on the normalized relative abundance or absolute quantification.

Provided herein are methods of treating a nonhematopoietic malignant tumor in a patient and methods of prognosing a nonhematopoietic malignant tumor in a patient, comprising administering to the patient a therapeutically effective amount of an agent that preferentially kills or inhibits proliferation or activity of leukocytes relative to nonhematopoietic cells.

A system and method for determining the immune status or immune cycle in a subject is provided. A sampling component for obtaining physiological data from the subject is provided together with a data storage component for storing the physiological data obtained from the subject. A processing component is provided to analyse the physiological data and thereby determine the immune status or periodicity of the immune cycle and the immune cycle of the subject. An output component for outputting the immune status or periodicity of the immune cycle, and the immune cycle of the subject and/or the future status or immune cycle of the subject is provided.

Disclosed herein are methods for treating subjects with breast cancer, comprising determining a therapeutic regimen for cancer by measuring the level (amount) of proteins of one or more biomarkers. Also disclosed are methods of predicting or assessing therapeutic outcome for subject.

Provided herein are kits for detecting and quantifying the level of a metastatic cancer biomarker(s) in a patient. The kits may contain a detection and quantifying means, such as, biomarker specific antibodies. Also provided are methods for determining a prognosis, a stratification and/or monitoring of a metastatic cancer in a patient. The level or activity of at least two biomarkers, such as obscurin, PI3K, E-cadherin, or N-cadherin is measured in a patient sample and compared to corresponding biomarkers in a control sample. A significant difference in the level or activity of the biomarkers between the patient sample and control is indicative of a metastatic cancer. In addition a method for treating a metastatic breast cancer via administration of a PI3K inhibitor and an agent that increases expression of obscurin is provided.

The present invention provides methods of diagnosing and monitoring systemic lupus erythematosus.

Methods and reagents for diagnosing, prognosing, and treating systemic lupus erythematosus (SLE) are disclosed, involving calculating an SLE risk score for a subject based on a level of each of an erythrocyte C4d (EC4d) marker, a B-cell C4d (BC4d) marker, anti-nuclear antibodies (ANA), and optional rule-out markers.

The present application is directed to to a method for therapy guidance and/ or therapy monitoring and/ or therapy stratification in a patient with shock and/or in a patient running into shock. In particular, the method comprises providing a sample from said patient, determining a level of DPP3 in said sample, and wherein the level of DPP3 in said sample is indicative of whether a treatment with an anti-ADM antibody or anti-ADM antibody fragment or anti-ADM non-Ig scaffold is required. In a preferred embodiment of the invention, the method comprises additionally determining in a sample from said patient a level of ADM-NH.sub.2.

The present invention is based, in part, on the identification of novel antibodies that have binding affinity for both PD-L1 and PD-L2 and methods of using same. In one aspect, an isolated monoclonal antibody, or antigen-binding fragment thereof, which specifically binds both PD-L1 and PD-L2, is provided. In one embodiment, both PD-L1 and PD-L2 are human PD-L1 and human PD-L2.

Methods for identifying subjects having bone loss by detecting bone microparticles in a sample of their bodily fluid are disclosed. Methods for monitoring bone loss and assessing efficacy of bone loss therapies by detecting bone microparticles in bodily fluid samples are also disclosed. Compounds for use as a negative control in the disclosed methods are provided as well as kits comprising such compounds.