Abstract: The present invention provides a sensitive and specific indirect homogeneous mobility shift assay using size exclusion chromatography to measure biologics such as vedolizumab and ustekinumab in a patient sample. The assays of the present invention are particularly advantageous for detecting the presence or level of biologics that target complex or large antigens including cell surface proteins, transmembrane proteins, heavily glycosylated proteins, and multimeric proteins, as well as antigens that cannot be purified, impure antigens, and partially or substantially purified antigens. The present invention also provides isolated soluble ?4?7 integrin heterodimers and isolated soluble IL-12p40 monomers that are suitable for use in the indirect assays described herein.

Abstract: The present disclosure provides methods for assessing mucosal healing in a patient with Crohn's Disease. The methods include detecting expression levels of analytes in a serum sample from a patient, and applying a mathematical algorithm to the expression levels, thereby producing a Mucosal Healing Index score for the patient. The present disclosure also provides kits that include two or more binding partners, each or which is capable of binding a different analyte measured in the disclosed mucosal healing assessment methods.

Abstract: In some aspects, the present invention provides methods for predicting whether a subject will develop autoantibodies to an anti-TNF? drug during the course of anti-TNF? drug therapy. In other aspects, the present invention provides methods for predicting the level of an anti-TNF? drug in a subject during the course of anti-TNF? drug therapy. Systems for predicting anti-TNF? drug levels and the likelihood of autoantibody formation during the course of anti-TNF? drug therapy are also provided herein. The present invention further provides methods for predicting a clinical outcome (e.g., endoscopic response) of a subject on anti-TNF? drug therapy.

Abstract: The present invention provides methods for personalized therapeutic management of a disease in order to optimize therapy and/or monitor therapeutic efficacy. In particular, the present invention comprises measuring an array of one or a plurality of biomarkers at a plurality of time points over the course of therapy with a therapeutic agent to determine a mucosal healing index for selecting therapy, optimizing therapy, reducing toxicity, and/or monitoring the efficacy of therapeutic treatment. In certain instances, the therapeutic agent is a TNF? inhibitor for the treatment of a TNF?-mediated disease or disorder.

Abstract: The present invention provides methods for selecting a suitable anticancer therapy, and for identifying and predicting response for the treatment of a gastric cancer.

Abstract: The present invention provides methods for analyzing genetic and/or metabolite biomarkers to individualize methotrexate (MTX) therapy. For example, the assay methods of the present invention are useful for predicting whether a patient will respond to MTX and/or has a risk of developing toxicity to MTX based upon the genotype of one or more folate pathway genes. The assay methods of the present invention are also useful for optimizing the dose of MTX in a patient already receiving the drug to achieve therapeutic efficacy and/or reduce toxic side-effects based upon the genotype of one or more folate pathway genes. In addition, the assay methods of the present invention are useful for predicting or optimizing the therapeutic response to MTX in a patient based upon the methotrexate polyglutamate and/or folate polyglutamate levels in a sample from the patient.

Abstract: The present invention provides compositions and methods for detecting the activation states of components of signal transduction pathways in tumor cells. Information on the activation states of components of signal transduction pathways derived from use of the invention can be used for cancer diagnosis, prognosis, and in the design of cancer treatments.

Abstract: The present invention provides assays for detecting and measuring the presence or level of anti-TNF? drug therapeutics and autoantibodies in a sample. The present invention is useful for optimizing therapy and monitoring patients receiving anti-TNF? drug therapeutics to detect the presence or level of autoantibodies (e.g., HACA and/or HAHA) against the drug.

Abstract: The invention provides novel biomarkers, kits, and methods of diagnosing, prognosing, and subtyping IBS. Also provided are methods for aiding in the diagnosis of irritable bowel syndrome by detecting the serum level of novel IBS biomarkers identified herein.

Abstract: The present invention provides novel citrullinated peptides, their use in methods for aiding, assisting, improving, or facilitating the diagnosis or prognosis of rheumatic diseases such as rheumatoid arthritis (RA), and methods for identifying novel citrullinated peptides that are immunoreactive with anti-citrullinated protein antibodies (ACPAs). The present invention also provides methods for detecting rheumatoid factor (RF) using novel RF detection reagents as a means to aid, assist, improve, or facilitate the diagnosis or prognosis of rheumatic diseases such as RA. Kits comprising at least one of the novel citrullinated peptides and/or RF detection reagents of the present invention are also provided.

Abstract: The present invention provides antibody-based arrays for detecting the activation state and/or total amount of one or a plurality of oncogenic fusion proteins in a biological sample such as whole blood or tumor tissue and methods of use thereof. In certain instances, the activation state and/or total amount of oncogenic fusion protein(s) present in a sample can be measured in combination with one or a plurality of signal transduction molecules. The compositions and methods of the present invention have the advantages of specificity associated with enzyme-linked immunosorbent assays, sensitivity associated with signal amplification, and high-throughput multiplexing associated with microarrays.

Abstract: The present invention provides methods for selecting a suitable anticancer therapy and for identifying and predicting response for the treatment of a gastric cancer by determining the expression level and/or activation level of one or more analytes in a cell such as a cancer cell from an ascites sample. The present invention also provides methods for selecting a suitable anticancer therapy and for identifying and predicting response for the treatment of a lung cancer such as a non-small cell lung cancer by determining the expression level and/or activation level of one or more analytes in a cell such as a cancer cell from a pleural efflux sample.

Abstract: The invention provides an ELISA assay for the determination of serum mast cell ?-tryptase levels using rabbit anti-tryptase as the capture antibody and alkaline phosphatase conjugated G3 as the detecting antibody. Luminescent substrate CPSD was used to enhance the assay sensitivity. Also provided are methods for aiding in the diagnosis of irritable bowel syndrome by detecting the serum level of ?-tryptase, histamine and/or prostaglandin E2.

Abstract: The present invention provides methods for selecting a suitable anticancer drug therapy, and for identifying and predicting response, for the treatment of colorectal cancer. The present invention also provides methods for monitoring the status of colorectal cancer and monitoring how a patient with colorectal cancer is responding to anticancer drug therapy.

Abstract: The methods and systems of the present invention are useful in the diagnosis of inflammatory bowel disease (IBD) and in the prognosis of IBD progression and disease complications. With the present invention, it is possible to predict outcome of disease and patients who will have a particular risk of disease complications and/or progression to surgery.

Abstract: The present invention provides compositions and methods for detecting the activation states of components of signal transduction pathways in tumor cells. Information on the activation states of components of signal transduction pathways derived from use of the invention can be used for cancer diagnosis, prognosis, and in the design of cancer treatments.

Abstract: The invention provides an ELISA assay for the determination of serum mast cell ?-tryptase levels using rabbit anti-tryptase as the capture antibody and alkaline phosphatase conjugated G3 as the detecting antibody. Luminescent substrate CPSD was used to enhance the assay sensitivity. Also provided are methods for aiding in the diagnosis of irritable bowel syndrome by detecting the serum level of ?-tryptase, histamine and/or prostaglandin E2.

Abstract: The present invention provides methods for selecting a suitable anticancer therapy, and for identifying and predicting response for the treatment of a gastric cancer.

Abstract: The present invention provides compositions and methods for detecting the activation states of components of signal transduction pathways in tumor cells. Information on the activation states of components of signal transduction pathways derived from use of the invention can be used for cancer diagnosis, prognosis, and in the design of cancer treatments.

Abstract: The present invention provides methods for analyzing a combination of biomarkers to individualize tyrosine kinase inhibitor therapy in patients who have been diagnosed with cancer. In particular, the assay methods of the present invention are useful for predicting, identifying, or monitoring the response of a tumor, tumor cell, or patient to treatment with a tyrosine kinase inhibitor using an algorithm based upon biomarker profiling. The assay methods of the present invention are also useful for predicting whether a patient has a risk of developing toxicity or resistance to treatment with a tyrosine kinase inhibitor. In addition, the assay methods of the present invention are useful for monitoring tyrosine kinase inhibitor therapy in a patient receiving the drug to evaluate whether the patient will develop resistance to the drug.