In one aspect, the present disclosure relates to a method for excluding a subject from the need for diagnostic testing for Parkinson's disease (PD). In another aspect, the present disclosure relates to a method for excluding a subject from recruitment into a clinical study for an investigational PD medication. In yet another aspect, the present disclosure relates to a method for screening a subject to determine whether the subject is ruled out as having PD, wherein the subjects who cannot be ruled out are administered a diagnostic test for PD, a treatment for PD, or a combination thereof.

Disclosed are novel means of stratifying patients into potential of positive response to mesenchymal stem cell therapy based on quantification of pretreatment levels of B regulatory cells. In one embodiment quantification of cells concurrently expressing CD5 and CD19. In another embodiment B regulatory cells are CD19+CD39?IL10+. In one embodiment the selection of B regulatory cells is quantified by flow cytometric means and patients possessing more than 7% IL-10 secreting CD19 cells are chosen for stem cell therapy. In some embodiments numbers of B regulatory cells are increased prior to treatment by administration of various interventions including providing GM-CSF, microbiome alteration or manipulation of oxidative stress.

The invention provides methods and systems for detecting a biomarker in a synovial fluid wherein the system also includes a control to ensure that the test sample is indeed synovial fluid. The biomarkers and the control for synovial fluid can be identified using proteomic methods, including but not limited to antibody based methods, such as an enzyme-linked immunosorbant assay (ELISA), a radioimmunoassay (RIA), or a lateral flow immunoassay.

The present invention relates to methods and other technologies that may be used to determine whether compositions (e.g., pharmaceutical compositions) comprising interleukin-10 molecules (e.g., pegylated interleukin-10) meet particular product-related specifications prior to being administered to a subject for the treatment and/or prevention of the diseases, disorders and conditions, and/or the symptoms thereof, described herein.

The present invention concerns the use of IL-10 as a biological marker for predicting the responsiveness of a house dust mite allergic patient to house dust mite allergen immunotherapy.

The invention relates to a method for prognostic evaluation of the disease progression of rheumatoid arthritis, in particular prognostic evaluation of the disease progression during treatment, and for the diagnosis and/or activity determination of rheumatoid arthritis by analysing cytokines from a human full blood sample. In the method according to the invention, a volume of a full blood sample of a human is transferred into at least one test tube containing a stimulating agent. As control samples, the same volume of a full blood sample of the human in each case is transferred into an empty test tube as a negative control and a test tube containing lipopolysaccharide as a positive control respectively. After incubation, the concentration of at least one proinflammatory cytokine is determined from the cell-free residue of each test tube. By way of an altered concentration of the at least one cytokine in the at least one test tube comprising the stimulating agent, the prognostic evaluation of the disease progression or the diagnosis is subsequently made. The invention further relates to an associated diagnostic kit and to the use thereof. The invention is applied in medical diagnostics and medical research.

The present invention includes methods, systems, and kits, for identifying and modifying the treatment of a systemic lupus erythematosus (SLE) patient prior to the presence of autoantibodies, comprising: (a) obtaining a dataset representing protein expression level values for cytokines and molecules; (b) assessing the dataset for protein expression levels of at least one innate serum mediator; (c) assessing the dataset for protein expression levels of at least one adaptive serum mediator; and (d) determining the likelihood that the patient will develop SLE prior to the onset of autoantibodies when compared to a control.

The present invention is directed to an isolated synthetic tripeptide of formula H-D-Phe-N-Methyl-L-Val-L-Ala-OMe (SEQ ID NO: 1), or a derivative thereof, and to the corresponding lipotripeptides, which are specific to Mycobacterium avium subsp. paratuberculosis (Map) S-type strain, as well as derivatives and conjugates thereof. The invention also concerns the use of these antigens in different methods and tests for detecting Map infection, especially by detecting humoral response and cell mediated response of infected animals. The invention is also directed to a genetic signature of Map and a mass spectrometry and NMR spectroscopy signature of Map presence or infection.

The present invention provides methods for using effluent obtained from medical procedures resulting in stomas or percutaneous drains or ports to assess diagnostic biomarkers indicative of disease. Identified biomarkers are used to inform surgical success and/or to assess and monitor efficacy of treatment.

The invention provides methods, kits and reagents for diagnosing fibromyalgia (FM) in an individual by determining whether the levels of one or more cytokines in the individual are altered, as compared to control levels. The altered level(s) or patterns of expression of the cytokines measured in the affected individual compared to the level from the control is predictive/indicative of FM in the individual.