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Hirosaki University Technology: Diagnostic Biomarker for Urothelial Carcinoma: K23-016

Discovery of N-linked glycan mutations in serum Ig specific to urothelial carcinoma.

The present invention relates to a urinary tract urothelial carcinoma diagnostic biomarker based on serum immunoglobulin (Ig) N-binding glycan structural variations. The diagnosis of urinary tract urothelial carcinoma (bladder cancer and renal pelvis/ureter cancer) is performed through urine cytology, imaging diagnostics, and invasive procedures such as cystoscopy and ureteroscopy with biopsy. However, both sensitivity and specificity are insufficient, and there is a demand for novel non-invasive markers that can detect urinary tract urothelial carcinoma at an early stage. Therefore, the inventors identified urinary tract urothelial carcinoma-specific glycan variations and demonstrated that the disease can be detected with high accuracy by scoring the associated glycans (see right figure). Additionally, they identified two types of lectins capable of distinguishing upper urinary tract urothelial carcinoma using a lectin array, allowing the entire process from serum collection to analysis to be completed in four hours. 【Advantages over prior art】 - As a serum marker, it is less invasive than cystoscopy. - Diagnostic accuracy far exceeds that of urine cytology, with AUC > 0.9. - Intended for use as an early diagnostic marker for urinary tract urothelial carcinoma.

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