About UroVysion® Bladder Cancer Kit

UroVysion As An Aid

FISH / Molecular Diagnostics

How UroVysion Works

Clinical Performance

Predictive Value



UroVysion As An Aid

UroVysion, the advanced molecular diagnostics generation of bladder cancer detection, aids—in conjunction with and not in lieu of standard diagnostic procedures—in the initial diagnosis of bladder carcinoma in patients with hematuria and also in the subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

In 2001 UroVysion became the first and is still the only FDA-approved molecular test for bladder cancer. UroVysion has these characteristics:

 

  • UroVysion’s sensitivity is better than the sensitivity of cytology for all stages and grades1
  • UroVysion’s most pronounced benefit is for “serious” recurrences (CIS, high-grade or invasive)1

 

 

Further characteristics of UroVysion:

 

  • Detects chromosomal abnormalities associated with the development and progression of bladder cancer
  • Offers the best available combination of sensitivity and specificity (Halling KC et al, J Urol. 2000; 164: 1768-1775)
  • Detects bladder cancer recurrence up to 6 months sooner than current diagnostic methods 1

 

Complete UroVysion Package Insert

 

UroVysion, as run by CYNOGEN, adheres to the FDA-approved labeling for UroVysion, without modifications in procedures that potentially may alter the performance of the assay. Studies show that, in patients previously diagnosed with bladder cancer, UroVysion in combination with cystoscopy provides a 97% sensitivity1. The overall specificity of UroVysion is 93%, as indicated in the FDA-approved labeling for UroVysion.

 

 

FISH / Molecular Diagnostics

UroVysion, a product of Abbott Molecular's rapidly growing molecular diagnostics business, provides important information based on the early detection of subtle changes in chromosomes found in patients' genes. This information may allow for the earlier diagnosis of bladder cancer and the monitoring for disease recurrence.

 

FISH (fluorescence in situ hybridization) has been widely studied and validated. UroVysion is a FISH-based test. According to research conducted by Abbott Molecular in 2008, 70% of 7,687 urologists participating in the research study were ordering UroVysion. Today, pathologists across the country are called upon to read UroVysion tests.

 

Click here to view a presentation on FISH technology.

 

 

How UroVysion Works

The UroVysion Bladder Cancer Kit (UroVysion Kit) is FDA-approved and designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from persons with hematuria suspected of having bladder cancer. Results from the UroVysion Kit are intended for use in conjunction with and not in lieu of current standard diagnostic procedures as an aid for the initial diagnosis of bladder carcinoma in patients with hematuria and the subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

 

UroVysion uses four DNA probes, each labeled with a different color fluorescent tag, that bind to specific gene sequences on human chromosomes. These probes reveal genetic abnormalities that may be associated with cancer.

 

Clinical Performance

UroVysion’s clinical performance is shown in the following data.

 

The FDA-approved labeling for UroVysion indicates the overall specificity of UroVysion.


Predictive Value

UroVysion is used to monitor for recurrence of bladder cancer. An anticipatory positive UroVysion result can be predictive of bladder cancer recurrence. An anticipatory positive is defined as a positive/abnormal result, despite an initial negative cystoscopy/histology, where a tumor is subsequently identified by cystoscopy/histology.

 

See the UroVysion package insert for more information about the positive predictive value (PPV) and negative predictive value (NPV) of UroVysion. Complete UroVysion Package Insert

 

 

Intended Use: The UroVysion Bladder Cancer Kit (UroVysion Kit) is designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from persons with hematuria suspected of having bladder cancer. Results from the UroVysion Kit are intended for use in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

 

Warnings and Limitations

  1. The UroVysion Kit has been optimized for identifying and quantitating chromosomes 3, 7, and 17, and locus 9p21 in human urine specimens.
  2. The performance of the UroVysion Kit was validated using the procedures provided in the package insert only. Modifications to these procedures may alter the performance of the assay.
  3. The clinical interpretation of any test results should be evaluated within the context of the patient’s medical history and other diagnostic laboratory test results.
  4. UroVysion assay results may not be informative if the specimen quality and/or specimen slide preparation is inadequate, e.g., the presence of excessive granulocytes or massive bacteruria.
  5. Technologists performing the UroVysion signal enumeration must be capable of visually distinguishing between the red and green signals.
  6. Positive UroVysion results in the absence of other signs or symptoms of bladder cancer recurrence may be evidence of other urinary tract related cancers, e.g., ureter, urethra, renal, and/or prostate in males, and further patient follow-up is justified. In a study conducted on patients with hematuria, 3 patients whose initial bladder cystoscopy was negative, were subsequently diagnosed with renal cancer within 6 months of this initial study visit. All 3 of these cases were positive by UroVysion.
  7. If UroVysion results are negative but standard clinical or diagnostic tests (e.g., cytology, cystoscopy) are positive, the standard procedures take precedence over the UroVysion test. Although the UroVysion Kit was designed to detect genetic changes associated with most bladder cancers, there will be some bladder cancers whose genetic changes cannot be detected by the UroVysion test.
  8. Ta stage solitary tumors smaller than 5mm could not be detected by UroVysion FISH. UroVysion FISH results are dependent on the amount of tumor cells that are deposited on the slide.

 

Caution:  United States Federal law restricts this device to sale and distribution to, or on the order of, a physician or a clinical laboratory; use is restricted to, by, or on the order of a physician.

 

Complete UroVysion Package Insert
Important Safety Information for UroVysion

 

FOR IN VITRO DIAGNOSTIC USE

 

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; 1768-1775.