A lysosomal pepstatin-insensitive proteinase as a novel...

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G01N 33/574 (2006.01) C12Q 1/37 (2006.01) G01N 33/543 (2006.01) G01N 33/573 (2006.01) G01N 33/577 (2006.01) G01N 33/58 (2006.01)

Patent

CA 2403373

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.

L'invention concerne des techniques diagnostiques et pronostiques permettant de détecter dans des échantillons vasculaires et de tissu la présence et l'activité de la protéinase lysosomiale insensible à la pepstatine, CLN2p, qui a été récemment associée au cancer du sein et constitue un nouveau biomarqueur du cancer du sein, y compris tumeurs du sein primaires, non primaires ou métastatiques, néoplasmes et carcinomes. L'activité mesurée de CLN2p est considérablement élevée dans les échantillons de tissu de sein qui proviennent de patientes présentant un carcinome du sein, par comparaison avec les taux de CLN2p d'échantillons témoins normaux ; cette activité de CLN2p est d'approximativement deux à dix-sept fois supérieure en présence de tumeurs du sein. Les taux supérieurs d'activité de CLN2p dans les tumeurs du sein ont été corrélés avec succès à plusieurs biomarqueurs de cancer du sein connus, tels que la cathepsine D, le récepteur des oestrogènes et le récepteur de la progestérone. L'invention concerne CLN2p comme nouveau biomarqueur utile dans la détection, le diagnostic et le pronostic du cancer du sein.

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