FDA Approves First Gene-Based Test, UroVysion(TM), for Diagnosis of Patients Suspected of Having Bladder Cancer
25 Janvier 2005 - 4:00PM
PR Newswire (US)
FDA Approves First Gene-Based Test, UroVysion(TM), for Diagnosis of
Patients Suspected of Having Bladder Cancer UroVysion shown to be
more sensitive than established methods in detecting bladder cancer
ABBOTT PARK, Ill., Jan. 25 /PRNewswire-FirstCall/ -- The U.S. Food
and Drug Administration has approved Abbott's UroVysion(TM) DNA
probe assay for use as an aid in the initial diagnosis of bladder
cancer in patients with hematuria (blood in urine) suspected of
having bladder cancer. With this approval, UroVysion represents the
first gene-based test available for both diagnosis and monitoring
of bladder cancer recurrence. The test is designed to detect
genetic changes in bladder cells in urine specimens using a
proprietary technology known as fluorescence in situ hybridization
or FISH. "UroVysion is significantly more sensitive than
conventional methods for the detection of bladder cancer," said
Michael Sarosdy, M.D., of San Antonio, Texas, a urologic oncologist
and lead investigator of the UroVysion study. "This new use should
allow physicians to make an earlier diagnosis, with earlier
treatment," Dr. Sarosdy said. The FDA based its approval on a
Premarket Approval Application (PMA) filed by Abbott in December
2003. Included in that filing were the results of a 23- site study
of 497 patients presenting with hematuria. Results demonstrated
that UroVysion had greater sensitivity than the most commonly used
testing method to detect bladder cancer. The study compared
UroVysion performed on urine samples to cystoscopy/histology
testing methods and demonstrated a clinical sensitivity of 68.6
percent and a clinical specificity of 77.7 percent. Urine cytology
was also performed and demonstrated a relative sensitivity of 39.2
percent and a relative specificity of 91.5 percent. "Studies have
shown that early and accurate detection of bladder cancer is key as
thousands die each year of this disease," said Mark S. Soloway,
M.D., professor, Department of Urology, University of Miami School
of Medicine, and a leading bladder cancer expert. "This is an
important new tool for clinicians to fight bladder cancer." In
2001, the FDA cleared UroVysion for use in conjunction with
cystoscopy to monitor patients for the recurrence of bladder
cancer. Prior to that, monitoring was done primarily by cystoscopy
and urine cytology. "The FDA's decision is important because it
gives physicians a more powerful diagnostic test than current
methods alone to detect one of the most common urological cancers,"
said Edward Michael, president, Abbott Molecular. "This approval is
the most recent example of Abbott's significant strides against
cancer through advanced molecular diagnostics and new treatments to
help patients live longer, healthier lives." About Fluorescence in
situ Hybridization The FISH technology platform is a system in
which genes and chromosomes are probed by fluorescent-labeled DNA
and then illuminated to allow for clearer identification. It has
been shown that by identifying abnormalities in chromosomal DNA,
clinicians can effect better treatments. In addition to UroVysion,
FISH is utilized in an FDA-approved device, PathVysion(R), to
quickly identify which patients with late-stage breast cancer are
suitable candidates for Herceptin therapy. Abbott scientists are
also exploring FISH's diagnostic capabilities for cervical,
esophageal, melanoma and hematological cancers. Product Limitations
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. FISH assay results may not be
informative if the specimen quality and/or specimen slide
preparation is inadequate. Positive FISH 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. A negative FISH result does not rule out
all bladder cancer, nor does it necessarily mean that an individual
will not develop bladder cancer in the future. About Bladder Cancer
The American Cancer Society estimates that in 2005 there will be
about 63,000 new cases of bladder cancer diagnosed in the United
States (about 47,000 men and 16,000 women). The chance of a man
developing this cancer at any time during his life is about 1 in 30
and for a woman, 1 in 90. In 2005 there will also be about 13,000
deaths from bladder cancer in the United States (about 9,000 men
and 4,000 women). Smoking causes nearly half of the deaths from
bladder cancer among men (48 percent) and less than a third of
bladder cancer deaths in women (28 percent). Over 500,000 people in
the United States have a history of this cancer. Approximately 50
percent of patients will experience a recurrence within two years
after an initial diagnosis of bladder cancer. This high rate of
recurrence requires that patients be monitored on a regular basis,
including up to four times a year for tumor recurrence. Abbott is a
global, broad-based health care company devoted to the discovery,
development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics.
The company employs more than 60,000 people and markets its
products in more than 130 countries. Abbott's news releases and
other information are available at the company's web site at
http://www.abbott.com/ . Source of bladder cancer statistics:
http://www.cancer.org/ DATASOURCE: Abbott Laboratories CONTACT:
Media, Don Braakman, +1-847-937-1237, or Financial, Christy Wistar,
+1-847-938-4475, both of Abbott Laboratories Web site:
http://www.cancer.org/ http://www.abbott.com/ Company News On-Call:
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