NEWTON, MassachusettsMatritech Inc has launched its new point-of-care diagnostic test for bladder cancerNMP22 BladderChek. Cytogen Corporation (Princeton, New Jersey) will distribute the product.
The test received FDA approval for use in monitoring bladder cancer patients for recurrence after surgery in conjunction with standard diagnostic procedures such as cystoscopy.
The test measures the level of the nuclear matrix protein NMP22 in the urine. NMP22 is often elevated in patients with bladder cancer, even at the earliest stages of the disease. The test requires only a few drops of a patient’s urine and returns results in 30 minutes.
Clinical trial results show that NMP22 BladderChek detected 4 times more early-stage bladder tumors and 2.5 times more life-threatening, high-grade tumors than cytology, Matritech and Cytogen said in a joint press release announcing the launch.
NMP22 BladderChek is the point-of-care format of Matritech’s NMP22 laboratory test kit (microplate). Clinical testing shows that BladderChek produces the same results as the laboratory test more than 90% of the time.