Bladder cancer can present in various grades and stages. FGFR3 has been shown to identify low-grade, lower risk bladder cancer from urine or tissue-based specimens, while UroVysion is an FDA approved test that has been proven to be very accurate in identifying high-grade, higher risk disease.1

FGFR3 URINE

The bladder portfolio of tests includes a proprietary biomarker called FGFR3 mutation analysis, which can be tested together with cytology and UroVysion from a single urine specimen. Bladder cancer can present in various grades and stages, and studies have shown FGFR3 to be associated with low-grade, lower risk tumors and predict better overall survival.2,3

689 of 690 cysto/biopsy negative patients were FGFR3 negative (specificity 99.9%), and 20 of 21 FGFR3 positive patients were cysto/biopsy positive (PPV 95.2%)4

Associated with low-grade, early stage bladder cancer and predicts better overall survival3

FGFR3 has been shown to detect tumors in the upper urothelial tract from voided urine specimens5

Rapid turnaround time of 3-4 days

Can be combined with UroVysion to
assist in covering the complete
spectrum of bladder cancer

References

  1. Halling KC, King W, Sokolova IA, et al. A comparison of cytology and fluorescence in situ hybridization for the detection of urothelial carcinoma. J Urol. 2000;164(5):1768-75.
  2. Van rhijn B, Van der kwast T, Liu L, et al. The FGFR3 mutation is related to favorable pT1 bladder cancer. J Urol. 2012;187(1):310-314.
  3. Liu X, Zhang W, Geng D, et al. Clinical significance of fibroblast growth factor receptor-3 mutations in bladder cancer: a systematic review and meta-analysis. Genet Mol Res. 2014;13(1):1109-1120.
  4. Karnes RJ, Fernandez CA, Shuber AP. A noninvasive multinalyte urine-based diagnostic assay for urothelial cancer of the bladder in the evaluation of hematuria. Mayo Clin Proc. 2012; 87(9):835-842.
  5. van Oers J, Zwarthoff E, Rehman I, et al. FGFR3 Mutations Indicate Better Survival in Invasive Upper Urinary Tract and Bladder Tumours. Eur Urol. 2009;55(3):650-658.
  6. van Rhijn BW, Vis AN, van der Kwast TH, et al. Molecular grading of urothelial cell carcinoma with fibroblast growth factor receptor 3 and MIB-1 is superior to pathologic grade for the prediction of clinical outcome. J Clin Oncol. 2003;21(10):1912-1921.
  7. Kamat AM, Dickstein RJ, Messetti F, et al. Use of fluorescence in situ hybridization to predict response to bacillus Calmette-Guérin therapy for bladder cancer: results of a prospective trial. J Urol. 2012;187(3):862-
FGFR3 TISSUE

Molecular grading through the use of proprietary biomarker FGFR3 can help determine the prognostic profile of bladder cancer patients through the FGFR3 Tissue test. This test analyzes the mutation and Ki-67 levels in the tissue, which together helps to determine whether a patient’s prognosis is favorable, intermediate, or poor.6

Assists with initial diagnosis and prognosis

Improves risk stratification of your non-muscle invasive bladder cancer patients

Patients with FGFR3 mutations and low Ki-67 levels appear to have better overall survival6

Rapid turnaround time of 3-4 days

References

  1. Halling KC, King W, Sokolova IA, et al. A comparison of cytology and fluorescence in situ hybridization for the detection of urothelial carcinoma. J Urol. 2000;164(5):1768-75.
  2. Van rhijn B, Van der kwast T, Liu L, et al. The FGFR3 mutation is related to favorable pT1 bladder cancer. J Urol. 2012;187(1):310-314.
  3. Liu X, Zhang W, Geng D, et al. Clinical significance of fibroblast growth factor receptor-3 mutations in bladder cancer: a systematic review and meta-analysis. Genet Mol Res. 2014;13(1):1109-1120.
  4. Karnes RJ, Fernandez CA, Shuber AP. A noninvasive multinalyte urine-based diagnostic assay for urothelial cancer of the bladder in the evaluation of hematuria. Mayo Clin Proc. 2012; 87(9):835-842.
  5. van Oers J, Zwarthoff E, Rehman I, et al. FGFR3 Mutations Indicate Better Survival in Invasive Upper Urinary Tract and Bladder Tumours. Eur Urol. 2009;55(3):650-658.
  6. van Rhijn BW, Vis AN, van der Kwast TH, et al. Molecular grading of urothelial cell carcinoma with fibroblast growth factor receptor 3 and MIB-1 is superior to pathologic grade for the prediction of clinical outcome. J Clin Oncol. 2003;21(10):1912-1921.
  7. Kamat AM, Dickstein RJ, Messetti F, et al. Use of fluorescence in situ hybridization to predict response to bacillus Calmette-Guérin therapy for bladder cancer: results of a prospective trial. J Urol. 2012;187(3):862-
UroVysion

UroVysion is the first and only FDA-approved molecular urine test that detects chromosomal changes associated with bladder cancer. This test has been shown to be highly sensitive for high-grade, higher risk disease.5 It also aids in the initial diagnosis of bladder cancer, and detects bladder cancer recurrence up to 6 months sooner than current diagnostic methods.5

Can be combined with FGFR3 Urine to assist in covering the complete spectrum (low grade to high grade) of bladder cancer

Available via our TC/PC virtual platform

Overall specificity of 93%, and a combined specificity with cystoscopy of 97%1

Rapid turnaround time of 3-4 days

In addition, a positive UroVysion result has been shown to predict recurrence during BCG therapy7

Additional Information for Pathologists

Working in conjunction with Pathology laboratories around the country, RosettaGX provides the technical component (TC) of UroVysion, while the Pathologist provides the professional component (PC). It is not necessary for Pathology laboratories to acquire specialized equipment or modify facilities.

Additional Information for Urologists

UroVysion is intended for initial diagnosis of patients with hematuria, or for monitoring recurrent urothelial carcinoma. Consider these hypothetical circumstances that a Urologist may consider UroVysion:

  • A Urologist who commonly uses cystoscopy with cytology and sees a high rate of recurrence in bladder cancer patients may choose to order UroVysion as an aid in detecting bladder cancer early.
  • A Urologist who commonly uses cystoscopy without cytology and seeks
    to detect carcinoma in situ (CIS) early may order UroVysion as an additional diagnostic aid.
  • A Urologist who uses cystoscopy with other tumor markers, and who has found that
    these markers can be affected by BCG or inflammation, may add UroVysion to the standard diagnostic procedures.

References

  1. Halling KC, King W, Sokolova IA, et al. A comparison of cytology and fluorescence in situ hybridization for the detection of urothelial carcinoma. J Urol. 2000;164(5):1768-75.
  2. Van rhijn B, Van der kwast T, Liu L, et al. The FGFR3 mutation is related to favorable pT1 bladder cancer. J Urol. 2012;187(1):310-314.
  3. Liu X, Zhang W, Geng D, et al. Clinical significance of fibroblast growth factor receptor-3 mutations in bladder cancer: a systematic review and meta-analysis. Genet Mol Res. 2014;13(1):1109-1120.
  4. Karnes RJ, Fernandez CA, Shuber AP. A noninvasive multinalyte urine-based diagnostic assay for urothelial cancer of the bladder in the evaluation of hematuria. Mayo Clin Proc. 2012; 87(9):835-842.
  5. van Oers J, Zwarthoff E, Rehman I, et al. FGFR3 Mutations Indicate Better Survival in Invasive Upper Urinary Tract and Bladder Tumours. Eur Urol. 2009;55(3):650-658.
  6. van Rhijn BW, Vis AN, van der Kwast TH, et al. Molecular grading of urothelial cell carcinoma with fibroblast growth factor receptor 3 and MIB-1 is superior to pathologic grade for the prediction of clinical outcome. J Clin Oncol. 2003;21(10):1912-1921.
  7. Kamat AM, Dickstein RJ, Messetti F, et al. Use of fluorescence in situ hybridization to predict response to bacillus Calmette-Guérin therapy for bladder cancer: results of a prospective trial. J Urol. 2012;187(3):862-