International Product Information

Matritech is in compliance with the European In Vitro Diagnostics Directive and has placed the CE Mark on all its NMP22 products, including the point-of-care format NMP22® BladderChek® Test. Compliance with this directive allows Matritech to market the NMP22 BladderChek Test and its other NMP22 products in the member countries of the European Union.


NMP22® BladderChek® Test
The NMP22 BladderChek Test is the only in-office test approved by the U.S. 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 U.S. FDA-approved four times for various formats and claims, most recently in April 2003 for point-of-care use for diagnosis.


NMP22® Test Kit
The NMP22 Test Kit is a quantitative microplate enzyme immunoassay that detects elevated levels of NMP22 protein.


Through its wholly owned subsidiary, Matritech GmbH, Matritech sells the NMP22 family of products throughout Europe and distributes selected products in Germany from such manufacturers as Hitachi, Orion and MBL. For more information, please see the Matritech GmbH web site.


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