Nestec S.a.

Prometheus Laboratories Inc.

Precision Ibd, Inc.

Nicholas Chi-Kwan Ling

Sharat Singh

Anjali Jain

Stefan Westin

Shui-Long Wang

Jared Salbato

Shui Long Wang

Fred Princen

Steven Lockton

Dunrui Wang

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.

Indirect homogeneous mobility shift assays for the detection of biologics in patient samples

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 &#x3b1;4&#x3b2;7 integrin heterodimers and isolated soluble IL-12p40 monomers that are suitable for use in the indirect assays described herein.

The present invention provides methods for aiding in the diagnosis of irritable bowel syndrome (IBS) in an individual. In particular, the present invention is useful for determining whether a sample from an individual is an IBS sample or a healthy control sample using a statistical algorithm. Thus, the present invention provides an accurate diagnostic prediction of IBS and is useful for guiding treatment decisions.

Antibodies to microbiome, stress factors and mast cell markers as diagnostic markers for IBS

The present invention provides cyclic peptides comprising a dimer of peptides, each peptide comprising a sequence corresponding to the HER2 splice variant HER2Delta16, wherein the cyclic peptide is cyclized via a disulfide bond between the peptides and via an amino acid linking the peptides. The invention also provides methods of making antibodies that specifically bind to HER2Delta16 homodimers using said cyclic peptides.

HER2DELTA16 peptides

HER2Delta16 peptides

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.

Citrullinated peptides for diagnosing and prognosing rheumatoid arthritis

The present invention provides devices and methods for aiding in the diagnosis of Crohn's disease. The devices and methods accurately identify whether a sample from an individual is associated with inflammatory bowel disease (IBD) or a clinical subtype thereof such as Crohn's disease (CD). The present invention is useful for determining whether a sample from an individual is an IBD sample, or differentiating between CD and ulcerative colitis (UC). Thus, the present invention provides an accurate diagnostic prediction of IBD or a clinical subtype thereof and prognostic information useful for guiding treatment decisions.

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San Diego, CA, United States of America

Nicholas Chi-Kwan Ling