Clinical Trial Background

Matritech's clinical trials for the NMP22® BladderChek® Test included 1,999 individuals from 23 trial sites in ten states. In addition to the trial results that showed increased sensitivity over cytology, previous study findings showed that the NMP22 BladderChek Test results are not hindered by the common occurrence of blood in urine samples. Other urine tests often exhibit false-positives or do not return an answer when blood contaminates the sample.

Matritech's laboratory test for NMP22 protein first received FDA approval in 1996 for monitoring and received a second approval for diagnosis in 2000. This test also measures the level of NMP22 protein in urine and has been approved by the FDA both for diagnosing patients with bladder cancer as well as monitoring previously diagnosed patients.

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