Global Point of Care
NMP22™ BladderChek™
The NMP22™ BladderChek™ Test is a fast, easy to use and non-invasive test that aids in the diagnosis and monitoring of bladder cancer, in conjunction with standard diagnostic procedures. With results in 30 minutes at the point-of-care, results can be delivered to patients during the same office visit, allowing a rapid and cost-effective aid in the detection of bladder cancer in patients at risk.
Benefits
- CE-marked and CLIA-waived.
- FDA cleared in the US for professional point-of-care and prescription home use.
- Ability to test patients at risk for bladder cancer.
- Easy testing process, only requiring 4 drops of urine to run the test.
- Fast results in 30 minutes, allowing consultation during the same visit.
- An ideal adjunct marker to cystoscopy as found in one study:
- 99% sensitivity when combined with cystoscopy, giving greater confidence that recurrent cancer has been detected.1
- 99% NPV overall when combined with cystoscopy, the most effective diagnostic combination for ruling out bladder cancer.1,2
- 99% sensitivity when combined with cystoscopy, giving greater confidence that recurrent cancer has been detected.1
Helpful Documents
PRODUCT DOCUMENTS
SPECIFICATIONS
Even at the early stages of the disease, elevated levels of NMP22 can be detected using an NMP22-specific assay, making it an ideal marker for early diagnosis and monitoring in conjunction with standard diagnostic procedures.1,2 The NMP22™ BladderChek™ Test works by detecting nuclear matrix protein (NMP22) in the urine, which bladder cancer cells release at higher levels than normal cells.3
PRODUCT CODE
| NMP22™ BladderChek™ Test | Code |
|---|---|
| NMP22™ BladderChek™ (24 count) | D1200 |
| NMP22™ BladderChek™ (24 count, CE Mark) | D1200E |
| NMP22™ BladderChek™ Test (10 count, CE Mark) | D1300E |
| NMP22™ BladderChek™ Control Kit (1 positive and 1 negative control) | D1250 |
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VIEW REFERENCES
- Grossman HB, Soloway M, Messing E, et al. Surveillance for recurrent bladder cancer using a point-of-care proteomic assay. JAMA. 2006;295(3):299-305. doi:10.1001/jama.295.3.299
- Grossman HB, Messing E, Soloway M, et al. Detection of bladder cancer using a point-of-care proteomic assay. JAMA. 2005;293(7):810-816. doi:10.1001/jama.293.7.810
- Kumar A, Kumar R, Gupta N. Comparison of NMP22 BladderChek Test and Urine Cytology for the Detection of Recurrent Bladder Cancer. Jpn. J. Clin. Oncol. 2006: 36(3) 172-175. https://doi.org/10.1093/jjco/hyi244