Clinical
Trial Background

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.
Grossman HB, Messing E, Soloway M, et al. Detection of Bladder Cancer using a point-of-care proteomic assay, a multi-center study. JAMA. 2005; 293(7):810-816.
Grossman HB, Messing E, Soloway M, et al. Surveillance for recurrent bladder cancer using a point-of-care assay. JAMA. 2006; 295, 299-305.
Matritech's laboratory test for NMP22 protein first received
FDA approval in 1996 for monitoring and received
a second approval as an aid in the diagnosis of bladder cancer in 2000. This test also
measures the level of NMP22 protein in urine and has been
approved by the FDA both as an aid in the diagnosis of bladder
cancer as well as monitoring previously
diagnosed patients.
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