| 摘要 |
The present invention describes diagnostic and prognostic assays to detect in vascular and tissue samples the presence and activity of the lysosomal pepstatin-insensitive proteinase, CLN2p, which has been newly found to be associated with breast cancer and serves as a novel biomarker for breast cancer, including primary, non-primary, or metastatic breast tumors, neoplasms and carcinomas. The activity of CLN2p was discovered to be significantly elevated when measured in breast tissue samples from patients with primary breast carcinoma, compared with CLN2p levels in normal sample controls, thereby demonstrating an approximately two- to seventeen-fold higher CLN2p activity in breast tumors. These higher levels of CLN2p activity in breast tumors were positively correlated with several known breast cancer biomarkers, such as cathepsin D, estrogen receptor and progesterone receptor. The present invention thus provides CLN2p as new biomarker for use in the detection, diagnosis and prognosis of breast cancer.
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