Non-invasive Urinary Biomarker for the Detection of Bladder Urothelial Carcinoma

Unmet Need
Bladder cancer is fifth most common cancer in the US and tenth most common cancer worldwide. In the US, over 80,000 new cases will be diagnosed and approximately 17,000 will die from the disease in 2018. Bladder cancer is diagnosed via the use of cystoscopy. However, this procedure is considered too costly and invasive to be utilized in routine screening. Urine cytology and ImmunoCyt are noninvasive alternatives to cystoscopies, but are limited by their low sensitivity. In addition, none of these current tests are capable of detecting cancer stem-like cells (CSC), which may be a driver of tumor initiation, metastasis and therapeutic resistance. Consequently, a noninvasive method that is able to detect CSCs in bladder cancer is a promising approach to diagnose tumor growth earlier.

Technology Overview  
Johns Hopkins researchers were able to identify a specific protein, CD24, that could be responsible for the properties of cancer stem-like cells (CSC) in the bladder. This protein is responsible for the proliferation of various other CSC-related molecules. Via the use of a training cohort of urine samples, the inventors were able to identify a panel of three molecules (CD24, CD49f, and NANOG) that can be used to diagnose urothelial carcinoma, the most common type of bladder cancer. When tested in an independent cohort of over 291 samples, this panel had a sensitivity of 82% and a specificity of 86% for urothelial carcinoma.

Stage of Development
Researchers validated their noninvasive diagnostic panel in 291 patient samples.

Publications
Ooki, A, et al. British Journal of Cancer 119, 961-970, 2018.
 

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