Biomarkers useful for diagnosing and assessing inflammatory disease are provided, along with kits for measuring their expression. The invention also provides predictive models, based on the biomarkers, as well as computer systems, and software embodiments of the models for scoring and optionally classifying samples. The biomarkers include at least two biomarkers selected from the DAIMRK group and the score is a disease activity index (DAI).

Antibodies and antigen-binding fragments of antibodies that bind to human fractional C-Reactive Protein (fracCRP), kits containing these antibodies and antibody fragments, and assays using these antibodies and antibody fragments.

A diagnostic method for inflammatory diseases, and the diagnostic kit used in the method. The diagnostic method includes the use of a novel tryptophan metabolite, 5-methoxytryptophan (5-MTP), as a diagnostic biomarker of inflammation. Specifically, a highly specific competitive ELISA is provided to measure 5-MTP level in human serum for gauging occurrence and severity of inflammatory diseases, including sepsis and systemic lupus.

A method of chronically reducing a patient's pathological inflammation via the administration of an agent that specifically binds to an alpha-4 integrin or a dimer comprising an alpha-4 integrin is disclosed. The agent provided must have a binding affinity such that administration is sufficient to suppress pathological inflammation, and the agent is administered chronically to provide long-term suppression of pathological inflammation.

The present invention is directed to therapeutic methods using IL-6 antagonists such as antibodies and fragments thereof having binding specificity for IL-6 to improve survivability or quality of life of a patient in need thereof. In preferred embodiments these patients will comprise those exhibiting (or at risk of developing) an elevated serum C-reactive protein level or a reduced serum albumin level prior to treatment. In another preferred embodiment, the patient's Glasgow Prognostic Score will be increased and survivability will preferably be improved.

A diagnostic assay strip includes a first layer that includes an iron mobile labelled specific binding partner that will bind to and iron biomarker from a sample and produce an iron complex and a vitamin A mobile labelled specific binding partner that will bind to a vitamin A biomarker from the sample and produce a vitamin A complex. A second layer includes iron and vitamin A test regions, and a control region. The iron test region has immobilized specific binding partners that will bind to the iron complex. The vitamin A test region has immobilized vitamin A biomarker that will bind to vitamin A mobile labelled specific binding partner, which is not bound to the vitamin A biomarker, passing from the first layer to the second layer. The control region has a moiety which will non-specifically bind to and immobilize the iron and vitamin A labelled specific binding partners. Methods of using the diagnostic assay strip are also discussed.

A multi-analyte sensor includes a body having a proximal end and a distal end. A plurality of strips is connected to one end of the body and a plurality of electrical conductors run through the body and into the plurality of strips. Exposed portions of first and second electrical conductors running through first and second strips are coated with analyte-responsive materials, such as a first molecular imprinted polymer (MIP) and a second MIP, respectively. The first MIP has binding sites for a first target analyte and the second MIP has binding sites for a second target analyte. The multi-analyte sensor may be part of a sensing device that also includes a controller and a data store.

The invention is to devices and methods for rapid determination of analytes in liquid samples. The devices and methods incorporate a sample dilution feature and multiple immunosensors for performing a ratiometric immunoassay on a first analyte and a second analyte, for example, hemoglobin and hemoglobin A1c or albumin and glycosylated albumin. The devices are preferably capable of being used in the point-of-care diagnostic field.

The present invention provides methods and systems to accurately detect and measure levels of endogenous antibodies, for examples endogenous IgA, to particular antigens in a biological sample from a companion animal, which is useful to diagnose inflammatory conditions, including bowel disease (IBD), gastrointestinal infections, and food sensitivities in companion animals, e.g., dogs or cats, and to distinguish among such gastrointestinal disorders. Such methods and systems identify whether a sample from the patient is associated with an inflammatory condition, infection, and/or food sensitivity condition, by using non-invasive means, thus conveniently providing information useful for guiding treatment decisions.

Methods of treating IBD in a subject using an anti-SMAD7 therapy, such as a SMAD7 antisense oligonucleotide, to reduce CCL20, IL8, or TNFα levels are disclosed. Methods of treating and managing IBD in a subject using an anti-SMAD7 therapy, such as a SMAD7 antisense oligonucleotide, based on CCL20, IL8, or TNFα levels are also disclosed. Also disclosed are methods of determining whether a subject with IBD is responsive or likely to be responsive to treatment an anti-SMAD7 therapy. Reduction of CCL20, IL8, or TNFα levels may correlated with IBD remission or decreases in CDAI score.