The present invention relates to the determination of levels or expression of particular biomarkers in biological samples which can be utilized to diagnose, prognose, and treat Kawasaki disease in subjects, and further to select subjects who would benefit from a Kawasaki disease therapy other than, or in addition to, IVIG treatment. Accordingly, the present invention encompasses methods and compositions that utilize these biomarkers for the diagnosis, prognosis, and treatment of Kawasaki disease.

The present disclosure provides monoclonal antibodies that target intracytoplasmic inclusion bodies in KD and methods for their use. Wherein an isolated antibody or antigen binding fragment thereof comprises: a heavy chain variable domain comprising: CDRH1, CDRH and CDRH3 sequences; and a light chain variable domain comprising: CDRL1, CDRL2, and CDRL3 sequences.

A biomarker for determining Kawasaki disease is identified by lipidomic analysis and mass spectrometry. With the use of the biomarker, we develop and provide a kit and a method capable of directly and objectively determining whether the subject suspected of having Kawasaki disease suffers from Kawasaki disease. A kit for determining Kawasaki disease, the kit including LOX-1 protein and/or part thereof having LAB-binding ability, the protein or part thereof being immobilized on a surface of a base material, is provided.

Provided is a method of determining whether a patient has bladder cancer, colon cancer, or breast cancer. Also provided is a method of determining whether a patient has a chronic inflammatory disease. Additionally provided is a method of evaluating patient response to a treatment for a chronic inflammatory disease. Further provided is a method of developing a treatment for a chronic inflammatory disease in a patient.