Rapid Bladder Cancer Test for Doctor's Office

The assay has been cleared by the US Food and Drug Administration (FDA).

The test, called BladderChek, detects a bladder cancer nuclear matrix protein, NMP22, in urine of patients. In clinical trials reviewed by the FDA, the test detected three times more early-stage bladder tumors and twice as many life-threatening, high-grade tumors as cytology. Only four drops of urine are needed for the simple in vitro test, which provides immediate results.

The test was developed by Matritech, Inc. (Newton, MA, USA). The company notes that urologists are using the BladderChek test in conjunction with cystoscopy, the primary clinical procedure used to visually identify tumors in the bladder. Nuclear matrix proteins are found in the nuclei of cells where they contribute to nuclear structure and regulate important cell functions. NMP2 is elevated in bladder cancer cells by 20-80 times the normal amount and is released into the urine of bladder cancer patients.

"The earlier physicians can detect cancer, the more effective treatment can be and the greater the chance of patient survival,” said Stephen D. Chubb, chairman and CEO of Matritech.




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