The NMP22® BladderChek® Test is the only in-office test approved by the FDA for the diagnosis of bladder cancer. The NMP22 BladderChek Test is a painless and non-invasive assay, performed on a single urine sample, that detects elevated levels of NMP22 protein. Healthy individuals generally have very small amounts of NMP22 protein in the urine. However, the level of NMP22 protein is often elevated in the urine of patients with bladder cancer, even at early stages of the disease. The test can be performed in a physician’s office with results delivered during the patient visit, allowing a rapid, accurate and cost-effective way to aid in the detection of bladder cancer in patients at risk. The use of the NMP22 protein has been FDA-approved four times for various formats and claims, most recently in April 2003 for point-of-care use for diagnosis.

NMP22® BladderChek® Test Fact Sheet