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FDA Clears NMP22 BladderChek for Monitoring of Bladder Cancer

FDA Clears NMP22 BladderChek for Monitoring of Bladder Cancer

 NEWTON, Mass—Matritech Inc. has received clearance from the US Food and Drug Administration to market NMP22 BladderChek for monitoring patients with a history of bladder cancer.

The test brings rapid detection into the urologist’s office through the use of proteomics technology, the company said in a news release. Four drops of urine are placed on the BladderChek cassette to detect the presence of NMP22, a nuclear matrix protein correlated with bladder cancer.

Clinical trial results reviewed by the FDA showed that NMP22 Bladder-Chek detected 4 times more early-stage bladder tumors and 2.5 times more life-threatening, high-grade tumors than cytology. The test is used in conjunction with cystoscopy.

 
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