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New Device Approval

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: UroVysion™ Bladder Cancer Kit
Applicant: Vysis, Inc. (a wholly-owned subsidiary of Abbott Laboratories)
Address: 3100 Woodcreek Drive , Downers Grove , IL 60515
Approval Date: January 24, 2005
Approval Letter: http://www.fda.gov/cdrh/pdf3/p030052a.pdf

What is it? The UroVysion™ Bladder Cancer Kit is a lab test used to:

• help doctors diagnose bladder cancer in patients who have blood in their urine, and
• to monitor patients already known to have bladder cancer.

The test uses fluorescence for the analysis of the chromosomes in the cells present in the patient’s urine to determine if they are cancerous cells. Fluoresence uses small, fluorescent-labeled DNA molecules (probes) to identify specific areas of DNA in human cells under a microscope.

The test can be done by a manual method with special staining accessories or it can be used with an automated tissue staining system.

How does it work? The UroVysion™ Bladder Cancer Kit is used to detect too many copies of chromosomes 3, 7, and 17 and/or the loss of part of the short arm of chromosome 9 (9p21) in cells found in the urine. These abnormalities suggest that the cells are cancerous and that bladder cancer is present.

• A sample of urine is taken from the patient.
• The cells in the urine are spun down.
• The cell pellet is spread on a microscope slide and dried.
• The cells on the slide are treated to separate the two strands of the DNA.
• Fluorescent DNA probes are added to the sample and incubated.
• The sample is analyzed by a pathologist or medical technologist using a microscope equipped to detect fluorescence.
• The fluorescence patterns seen in the cells on the slide are used to determine whether bladder cancer cells are present.

 When is it used? The UroVysion™ Bladder Cancer Kit is used in persons who have blood in their urine and may have bladder cancer.

 What will it accomplish? The UroVysion™ Bladder Cancer Kit, used together with the current standard diagnostic procedures, helps in the diagnosis of bladder cancer and monitoring of patients with bladder cancer.

 When should it not be used? There are no contraindications for this device.

Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf3/p030052.html

Other:

Bladder cancer information:
http://www.nlm.nih.gov/medlineplus/bladdercancer.html

American Cancer Society: Learn About Bladder Cancer
http://www.cancer.org/docroot/LRN/LRN_0.asp?dt=44

Updated March 10, 2005

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