VYSI
biz.yahoo.com
Thursday November 30, 8:30 am Eastern Time
Press Release
SOURCE: Vysis, Inc.
Vysis Submits FDA Application for First Genomic
DNA-Probe Test For Monitoring Recurrence of Bladder Cancer
Non-Invasive Genomic Test Addresses Substantial Market Opportunity
DOWNERS GROVE, Ill., Nov. 30 /PRNewswire/ -- Vysis, Inc. (Nasdaq: VYSI - news), announced today that it had
submitted its clinical trial data to the U.S. Food and Drug Administration on its UroVysion(TM) assay for monitoring recurrence
of bladder cancer. The assay is based on the detection of genetic changes in bladder cells utilizing Vysis' proprietary
fluorescence DNA probe technology. This assay is the first genomic DNA-probe test for monitoring recurrence of bladder
cancer to be submitted to the FDA.
``Our UroVysion test represents another key cellular genomic assay utilizing Vysis' patented technology for the identification of
chromosomal abnormalities in cancer,'' stated John Bishop, president and CEO of Vysis. ``It is becoming increasingly clear that
abnormalities in numbers of chromosomes and genes are a significant early event in the cancer process. Vysis' Fluorescence in
situ Hybridization (FISH) technology platform is uniquely positioned to detect these abnormalities easily and cost effectively in
routine clinical laboratories. Having this platform fully developed now allows us to continue to accelerate our product pipeline
for clinical applications beyond that of bladder cancer.''
``The UroVysion assay is Vysis' sixth submission of a genetic test to the FDA,'' stated Russel Enns, Ph.D., vice president of
regulatory and clinical affairs at Vysis. ``Our leadership in conducting multi-site evaluations to clinically validate genetic testing
products is evidence of our corporate focus and capability in bringing genomic tests to the routine clinical marketplace.''
The Company collaborated with the Mayo Clinic on the development and pre-clinical trials of the UroVysion assay. The Mayo
Clinic published its significant pre-clinical trial data involving the use of Vysis' DNA probe set in the November issue of the
Journal of Urology.
Substantial Market for Bladder Cancer Detection
Bladder cancer is a leading site of cancer worldwide. According to the American Cancer Society (ACS) and EUCAN, it is
estimated that there will be approximately 53,000 and 83,000 new cases diagnosed in 2001 in the United States and European
Union, respectively. The company estimates that there are well over one million patients living with the disease in the U.S. and
Europe. When bladder cancer is found at an early stage and properly treated, the five- year relative survival rate is 94 percent,
according to the ACS. 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, up to as many as
four times a year for tumor recurrence. The current monitoring is done by cystoscopy, an invasive procedure, and by urine
cytology. Urine cytology consistently has been proven to be unreliable.
``Based on the large number of monitoring events, UroVysion should provide another significant revenue source for Vysis in
2001,'' added Bishop.
Vysis, Inc., Downers Grove, Ill., is a genomic disease management company that develops, commercializes and markets
DNA-based clinical products providing information critical to the evaluation and management of cancer, prenatal disorders and
other genetic diseases. The company has direct sales operations in the United States and Europe; a marketing partnership in
Japan with Fujisawa Pharmaceutical Co.; and a worldwide distribution network.
The statements in this press release concerning Vysis' future financial results as well as any other statements which are not
historical facts, are forward-looking statements and are subject to risks and uncertainties inherent in the company's business.
These risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by the
forward-looking statements, include: the market acceptance of the company's clinical products; the extent to which the clinicians
or laboratories performing the procedures with the company's products are able to obtain third-party reimbursement; the ability
of the company to successfully market and sell its clinical products, other products and equipment; competition; compliance by
the company with regulatory requirements and the timely receipt of necessary governmental approvals; the company's ability to
manufacture products in sufficient quantities; the company's ability to maintain intellectual property protection for its proprietary
products, to defend its existing intellectual property rights from challenges by third parties, and to avoid infringing intellectual
property rights of third parties; and the company's cost control efforts. In addition, a detailed discussion of risks and
uncertainties may be found in the company's periodic filings with the Securities and Exchange Commission. Vysis disclaims any
intent or obligation to update these forward-looking statements.
To receive Vysis, Inc.'s latest news release and other corporate documents, free of charge via fax, simply dial
1-800-PRO-INFO. Use company ticker VYSI.
SOURCE: Vysis, Inc. |
