- A tissue test for bladder cancer to determine the molecular grade and risk of progression.
- A unique combination of immunohistochemistry to detect the presence or absence of FGFR3 mutations and the density of Ki-67 staining.
- A useful complement to pathologic diagnosis to help eliminate the variability of assessment.
- Research strongly supports the correlation of FGFR3 mutations and a lower risk of progression in non-muscle invasive bladder cancer.
CertNDx Molecular Grading
The clinical management of non-muscle invasive bladder cancer represents a significant challenge because of the high rate of recurrence and progression. Grading of bladder tumors can be challenging and there is often variability in the grading. Since urologists rely on this information to determine the proper course of treatment and management, it is critical to provide as accurate a diagnosis as possible.
The CertNDx™ Bladder Cancer Assay for Molecular Grading is a tissue-based test that provides an objective method of grading bladder tumors and offers additional insight into which tumors are likely to progress. Through a unique combination of immunohistochemistry and DNA mutation analysis, the assay detects Ki-67 protein antigens and FGFR3 mutations to assign a molecular grade and determine the risk of progression.
When combined with pathologic diagnosis, the CertNDx test can assist both the pathologist and the urologist in determining the most appropriate course of treatment and follow-up.
What Do Your Results Mean?
|Grade||Biomarker Status||Risk of Disease|
|mG1||FGFR3 mutant with low Ki-67||2 - 3% risk of disease progression at year 5 and ~5% at year 10|
FGFR3 mutant with high Ki-67
FGFR3 wild-type with low Ki-67
|~12% risk of disease progression at year 10|
|mG3||FGFR3 wild-type with high Ki-67||~31% risk of disease progression at year 5 and >50% at year 10|
Sample Report: CertNDx mG3