IUrisure is a product that detects the methylation of the AL021918.2 and VIM genes in exfoliated urothelial cells from urine. It can screen for urothelial carcinoma, including bladder cancer, ureteral cancer and renal pelvis cancer, with bladder cancer being the most prevalent among urothelial malignancies.
Urothelial carcinoma is cancer that starts in urothelium, the tissue that lines parts of urinary system. Urothelial carcinoma accounts for about 90% of all cases of bladder cancer and 7% of all cases of kidney cancer, including cancer in renal pelvis and ureter. Bladder and kidney cancers caused by urothelial carcinoma have similar symptoms. They also have similar prognoses – caught early on, these cancers are easily treated, but often come back.
80%-90% of bladder cancer patients first discover abnormalities as hematuria.
Chronic urinary tract infections and kidney stones may significantly increase the risk of bladder cancer.
Smoking and Exposure to carcinogens
e.g., indwelling catheters, stones.
Performed on a urine sample, reducing the number of recurrent cystoscopies.
Overall Sensitivity: 92.94%, Specificity: 92.83%.
For hematuria triage, treatment assessment & recurrence surveillance.
Urine can be collected at the hospital or at home.
Results available within 4.5h since sample processing.
Enables timely treatment by detecting molecular changes before clinical symptoms.
The study included a total of 1,571 valid samples for statistical analysis, comprising 637 samples of UC and 934 samples of non-UC. The results showed a sensitivity of 92.94% and a specificity of 92.83%.