The present invention relates to the identification and use of markers indicative for the response of a subject to immunotherapy as anti-cancer treatment. The markers are particularly useful in predicting response of a subject to immunotherapy with PD-1 or PD-L1 antagonists in the treatment of cancer. PD-1 and PD-L1 antagonists are typically used as immunotherapy in the treatment of several types of cancer, including melanoma, non-small cell lung cancer (NSCLC), and squamous cell carcinoma.

The present invention provides a diagnostic kit for detecting the presence or quantity of one or more test analytes within a test sample taken from a body surface of a mammal, the diagnostic kit comprising: a separate insert for a lateral flow device (200, 411) comprising a membrane (201) fixed to a rigid support (202) and, the separate insert being configured to obtain the test sample; a lateral-flow assay device configured (300, 400) to accept the separate insert (200, 411); a securing member (210) configured to releasably attach (211) the separate insert to a body surface of a mammal (213); wherein the securing member (210) comprise an expandable layer (212) configured to apply pressure to the separate insert (200, 411) thereby pressing the separate insert (200, 411) against the body surface of the mammal (213).

The purpose of the present invention is to provide a method for detecting, in a selective and simple manner, an oxidized form of HD5 which is human α-defensin, that is, HD5 having intramolecular disulfide bonds that function beneficially in the human body.

[Solution] The present invention relates to: two kinds of novel monoclonal antibodies that contain amino acid sequences of SEQ ID NO: 1-6 or 7-12 as a CDR and that specifically bind to human α-defensin HD5 having intramolecular disulfide bonds; an immunological detection method using the antibodies; and a kit containing the antibodies.

Method of diagnosing and treating inflammatory bowel disease are disclosed herein. Inflammatory bowel disease can be treated and diagnosed using cathelicidin peptides and detection agents thereof. Specifically, method of treating and diagnosing Crohn's disease and ulcerative colitis are disclosed herein.

It has been demonstrated that the level of HBP increases in individuals that have bacterial meningitis. Accordingly, the level of HBP in an individual can be used to determine whether or not an individual has bacterial meningitis.

An object of the invention is to provide a method for detecting cancer in a simple and highly accurate manner, and a reagent that can be used in the method. A method for detecting cancer (excluding renal cell cancer), which comprises measuring the level of Azurocidin (AZU1) in a sample, in which it is determined that cancer is detected when a measured value exceeds a preset reference value. The cancer is preferably selected from the group consisting of stomach cancer, breast cancer, colorectal cancer, and lung cancer. A reagent containing an antibody that specifically recognizes AZU1 is used in detecting cancer (excluding renal cell cancer).

A method of diagnosing and treating urinary tract obstruction that includes obtaining a urine sample from a human patient; detecting whether a predetermined uroepithelial peptide or predetermined urinary protein is present in the urine sample by either contacting the urine sample with an anti-uroepithelial peptide antibody and detecting binding between the uroepithelial peptide and the antibody or contacting the urine sample with an anti-urinary protein antibody and detecting binding between the urinary protein and the antibody; diagnosing the patient with urinary tract obstruction when the presence of either the predetermined uroepithelial peptide or predetermined urinary protein is detected; and operatively or non-operatively treating the patient to correct or remove the urinary tract obstruction.

A method to predict a propensity of an individual to develop atopic dermatitis is disclosed. The method, which involves use of biological markers, can also be used to evaluate the efficacy of a composition to treat atopic dermatitis.

A targeted DEFA5 antibody is disclosed herein. The targeted DEFA5 antibody has a high degree of specificity with DEFA5 protein, particularly with peptide sequences of the P, B, and/or M binding sites of the DEFA5 protein. The targeted DEFA5 antibody may be incorporated into an assay for diagnosing and treating ulcerative colitis and Crohns disease in a subject suffering from inflammatory bowel disease. The assay may be provided in a kit. The targeted DEFA5 antibody may be used in a method for measuring the level of DEFA5 or DEFA5 expression in a sample collected from a subject, and determining, based on the level of DEFA5 or DEFA5 expression, whether the subject is suffering from ulcerative colitis or Crohns disease. A treatment may be based on the determination of whether the subject has ulcerative colitis or Crohns disease.

A method of detecting epithelial cancer is described that includes the steps of: (a) determining the level of beta defensin 3 (BD-3) and beta defensin 2 (BD-2) in a suspect sample obtained from a subject; (b) comparing the level of BD-3 to BD-2 determined in the suspect sample to obtain a suspect BD-3/BD-2 ratio, (c) comparing the suspect BD-3/BD-2 ratio to a healthy BD-3/BD-2 ratio to obtain a diagnostic BD-3/BD-2 ratio; and (d) characterizing the subject as having epithelial cancer if the diagnostic BD-3/BD-2 ratio is greater than 1. A microfluidic device for detecting epithelial cancer using the diagnostic BD-3/BD-2 ratio is also described.