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.