Scimedx Corporation - Bladder Cancer Diagnosis with ImmunoCyt™/ uCyt+™

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IFA Assays
	Bladder Cancer
	Main Page on Bladder Cancer
	Overview of Bladder Cancer
	FAQ on Bladder Cancer
	ImmunoCyt™ / uCyt+™
	Summary of Procedure
	FAQ on ImmunoCyt™ / uCyt+™
	Certification

Bladder Cancer Diagnosis with ImmunoCyt™ / uCyt+™

Bladder cancer

Bladder cancer is the most common tumor of the urinary system and the fifth most common cancer in North America. It is estimated that 75,000 new cases of bladder cancer will be diagnosed in 2008, and that 16,000 individuals will die from it. The World Health Organization estimates that there are 330,000 new cases annually worldwide. Bladder cancer prevalence is steadily increasing and its projected rise is 28% by 2010 for both men and women.

The diagnosis of bladder cancer currently relies on identifying malignant cells by urine cytology, with or without adjunct tests, and also by visualizing the tumor by cystoscopic examination and tissue biopsy. Despite its low sensitivity (35% to 40%)[1] in the detection of urothelial carcinoma (UC) of all grades and stages (17% in grade 1, 61% in grade 2 and 90% in grade 3)[1], urine cytology remains the most commonly used non-invasive test.

More on bladder cancer

ImmunoCyt™/ uCyt+™

ImmunoCyt™ / uCyt+™ is a non-invasive test for detecting superficial bladder cancer. Through a simple urine sample, this test detects the presence of cancerous cells with the help of a fluorescence microscope.

Currently, testing for bladder cancer is carried out by urinary cytology in conjunction with a cystoscopy, an extremely invasive procedure. For low-grade tumors, the sensitivity obtained with ImmunoCyt™/ uCyt+™ is up to four times higher than that of conventional urinary cytology. With regard to overall detection of bladder cancer, ImmunoCyt™ / uCyt+™ combined with urinary cytology, shows greater sensitivity, in the range of 85% to 95%. ImmunoCyt™ has FDA clearance for commercialization in the United States for the monitoring of bladder cancer.

Current commercialization activities related to ImmunoCyt™/uCyt+™ include:

Distribution and development agreements with several reference laboratories and independent private laboratories in the United States
International Distribution Network
Agreements with ALCOA and ALCAN for use of ImmunoCyt™ / uCyt+™ as a screening tool for bladder cancer in high-risk populations, for research use only (RUO)