Methods and assays for detecting natalizumab in a sample, natalizumab-peptide complexes in a sample, and point-of-care devices for detecting natalizumab in a sample are described herein.

Biomarkers predictive of responsiveness to integrin beta7 antagonists, including anti-beta7 integrin subunit antibodies, and methods of using such biomarkers are provided. In addition, methods of treating gastrointestinal inflammatory disorders such as inflammatory bowel diseases including ulcerative colitis and Crohn's disease are provided. Also provided are methods of using such predictive biomarkers for the treatment of inflammatory bowel diseases including ulcerative colitis and Crohn's disease.

Provided herein is a method of monitoring the change of the alpha-4 integrin activities in an individual by correlating with the soluble vascular cell adhesion molecule (sVCAM) and/or soluble mucosal addressin cell adhesion molecule (sMAdCAM) levels. Particularly, this method can be used, for example, to evaluate the pharmacokinetics and pharmacodynamics (PK/PD) of an alpha-4 integrin inhibitor used to treat a disease associated with pathological or chronic inflammation.

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.

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.

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 α4β7 integrin heterodimers and isolated soluble IL-12p40 monomers that are suitable for use in the indirect assays described herein.

The present invention concerns methods of diagnosing and treating a malignant neoplasm of the CNS by detecting mammalian tissue expressing integrin alpha 10 subunit or a fragment or variant thereof, and administering a drug specific for integrin alpha 10 subunit.

The present invention in various aspects and embodiments involves pharmaceutical compositions prepared by contacting a candidate α- or β-integrin-binding molecule, or panel thereof, with an integrin heterodimer, and quantifying heterodimer disruption by the candidate molecule. An integrin-binding molecule, or derivative thereof, that disrupts the integrin heterodimer is selected and is formulated into a pharmaceutical composition for administration to a subject, e.g., who has a disease or disorder related to abnormal vascularization.

In one aspect, the present disclosure relates to a method for determining risk of ovarian cancer in a patient, the method including: providing a biological sample from the patient; measuring a level of CA1225 in the biological sample; measuring a level of SEZ6L in the biological sample; and identifying that the patient is at risk of ovarian cancer based on the level of CA125 and the level of SEZ6L. In one or more embodiments, the method further includes measuring a level of HE4 and ITGAV. In another aspect, the present disclosure relates to a kit, system, or computer program for performing a method described herein.

In a first aspect, the present invention relates to an antibody directed against the alpha-11 integrin subunit, in particular, said antibody is an antibody binding the same epitope as the antibody produced by the hybridoma deposited as DSM ACC3320. Further, the present invention relates to a method for detecting the alpha-11 integrin subunit in a sample. In particular, the antibody according to the present is an anti- body suitable for use in samples being cryopreserved and cryosectioned or formaldehyde fixed and paraffin embedded. The present invention relates further to a kit for detecting the alpha-11 integrin subunit containing the antibody according to the present invention. Finally, the present invention provides the antibody in a humanized form. The antibody, in particular, in its humanized forms are useful for antibody drug conjugates.