Abstract: The present invention relates to methods of diagnosing the presence of a non-specific disease or disorder in a subject, wherein a determined level of YKL-40 above a reference level indicates the presence of a non-specific disease or disorder. The subject may suffer from a variety of diseases or disorders. The reference level may be a reference level obtained from healthy individuals or it may be a previous measurement obtained from the same subject. The present invention furthermore relates to a method for classifying the severity of a non-specific disease or disorder in a subject, wherein a determined level of YKL-40 above or below one or more reference levels gives the severity of said non-specific disease or disorder. The present invention further relates to a kit and a device that may be used in the method of the present invention comprising means for measuring the level of YKL-40 in a sample; and means for comparing the measured level of YKL-40 with at least one reference level of YKL-40.

Abstract: The present invention relates to methods of diagnosing the presence of a non-specific disease or disorder in a subject, wherein a determined level of YKL-40 above a reference level indicates the presence of a non-specific disease or disorder. The subject may suffer from a variety of diseases or disorders. The reference level may be a reference level obtained from healthy individuals or it may be a previous measurement obtained from the same subject. The present invention furthermore relates to a method for classifying the severity of a non-specific disease or disorder in a subject, wherein a determined level of YKL-40 above or below one or more reference levels gives the severity of said non-specific disease or disorder. The present invention further relates to a kit and a device that may be used in the method of the present invention comprising means for measuring the level of YKL-40 in a sample; and means for comparing the measured level of YKL-40 with at least one reference level of YKL-40.

Abstract: This invention provides methods for detecting cancers and for evaluating the prognosis of cancer patients. In particular, the methods of this invention utilize YKL-40 as a marker for the presence or absence of a cancer and for the prognosis (e.g. likelihood of recurrence) of a cancer. Elevated levels of YKL-40 are indicative of the presence of a cancer in undiagnosed subjects and indicate likely recurrence of the cancer in subjects diagnosed as having a cancer.

Abstract: The invention is a method of identifying the presence of a disease state in a mammal which is associated with degradation of connective tissue in the mammal which contains the protein known as YKL-40. The method is a competitive immunoassay for YKL-40. It can be used, for example, to identify the presence of inflammatory or degenerative joint disease and tumor metastasis (to the extent it can be correlated to serum YKL-40 levels). Serum YKL-40 levels as detected and quantified by the inventive method are also suggestive of the prognosis for the length of survival in breast cancer patients following recurrence and/or metastasis of their cancers.