NEWTON, MassMatritech 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.