Nestec S.a.

Prometheus Laboratories Inc.

Prometheus Biosciences, Inc.

Shui Long Wang

Sharat Singh

Linda Ohrmund

Scott Hauenstein

Hua Gong

Nicholas Chi-Kwan Ling

Dunrui Wang

The present invention provides assays for detecting and measuring the presence or level of neutralizing and non-neutralizing autoantibodies to biologics such as anti-TNF&#x3b1; drug therapeutics in a sample. The present invention is useful for monitoring the formation of neutralizing and/or non-neutralizing anti-drug antibodies over time while a subject is on biologic therapy. The present invention is also useful for predicting and/or determining the cross-reactivity of neutralizing anti-drug antibodies in a subject's sample with alternative biologic therapies. As such, the present invention provides information for guiding treatment decisions for those subjects receiving therapy with a biologic agent and improves the accuracy of optimizing therapy, reducing toxicity, and/or monitoring the efficacy of therapeutic treatment to biologic therapy.

Assays for detecting neutralizing autoantibodies to biologic therapy

Systems and assay methods are disclosed for detecting an autoantibody in a sample. In certain instances, the systems and methods employ a mass tag releasably connected to an antigen. The tag is thereafter released for detection. A tag can be detected by mass spectrometry or in certain instances the tag is fluorescent. Methods for diagnosing a disease or disorder in a subject are also disclosed.

Addressable antibody arrays and methods of use

The present invention provides assay methods for the determination of one or more anti-drug antibody (ADA) isotypes in a sample. As a non-limiting example, the assays of the present invention are particularly useful for determining different ADA isotypes in samples from ADA-positive patients receiving an anti-TNF&#x3b1; drug such as REMICADE&#x2122; (infliximab) or HUMIRA&#x2122; (adalimumab). The present invention also provides methods for optimizing therapy and/or reducing toxicity in subjects receiving TNF&#x3b1; inhibitors for the treatment of TNF&#x3b1;-mediated disease or disorders.

Methods for determining anti-drug antibody isotypes

The present invention provides assays for detecting and measuring the presence or level of anti-TNF&#x3b1; drug therapeutics and autoantibodies in a sample. The present invention is useful for optimizing therapy and monitoring patients receiving anti-TNF&#x3b1; drug therapeutics to detect the presence or level of autoantibodies (e.g., HACA and/or HAHA) against the drug.

Assays for the detection of anti-TNF drugs and autoantibodies

The invention provides an ELISA assay for the determination of serum mast cell &#x3b2;-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 &#x3b2;-tryptase, histamine and/or prostaglandin E.

Methods for diagnosing irritable bowel syndrome

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.

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San Diego, CA, United States of America

Shui Long Wang