Quest Diagnostics Incorporated , the nation's leading provider of gene-based medical testing, with laboratories across the country, today announced that it has begun offering Abbott Laboratories' Vysis UroVysion® DNA Probe Assay, a non-invasive method for monitoring the recurrence of bladder cancer in patients previously diagnosed with the disease. In March 2002, the U.S. Food and Drug Administration (FDA) cleared Abbott Laboratories' use of new clinical data in the test's labeling as providing further evidence of the test's effectiveness in monitoring bladder cancer recurrence.
UroVysion can be used in conjunction with cystoscopy and is the only DNA-based test currently available for monitoring the recurrence of bladder cancer. The UroVysion assay is both highly sensitive and highly specific and, in many cases, can detect the presence of cancer cells in urine before a cancerous growth can be detected through cystoscopic visual inspection or urine cytology.
The test is based on Fluorescence in situ Hybridization (FISH) technology, which is able to detect genetic changes in tumor specimens with a high degree of accuracy. In contrast to other methods for examining the presence of cancerous cells, with FISH, the cells need not be destroyed and are able to remain physically intact.
In addition to UroVysion, Quest Diagnostics offers Abbott Laboratories' Vysis PathVysion® HER-2 Assay. In December 2001, the FDA approved the use of PathVysion to help physicians select appropriate patient candidates for Herceptin therapy based on patients' genetic profiles.
PathVysion is a gene-based breast cancer test that identifies women with metastatic breast cancer who are HER-2 positive and who could benefit from Herceptin® therapy. The presence of multiple copies of the HER-2 gene is a key determinant in the rapid growth of tumor cells in 25 to 30 percent of breast cancer patients. Herceptin, developed by Genentech, Inc., is a targeted monoclonal antibody treatment for women with HER-2 positive metastatic breast cancer, an aggressive form of the disease.
"As early adopters of UroVysion and PathVysion, we are excited to offer physicians these FISH-based tests as part of our comprehensive pathology and oncology testing menu," said Lucia Quinn, Senior Vice President, Advanced Diagnostics, for Quest Diagnostics.
About Bladder Cancer:
It is estimated that there were approximately 53,000 new cases of bladder cancer diagnosed in 2001 in the United States, according to the American Cancer Society (ACS).
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 four times a year. Prior to FDA clearance of the Vysis UroVysion test in August 2001, monitoring was done primarily by cystoscopy, an invasive procedure, and by urine cytology.
About Breast Cancer:
Responsible for $6 billion in direct medical costs annually in the United States, breast cancer is the most common form of cancer among women and the second leading cause of cancer-related deaths among women age 35 to 54. About 192,000 new cases of breast cancer are diagnosed each year in the United States. Some 1.7 million American women are currently living with the disease.
About Quest Diagnostics
Quest Diagnostics Incorporated is the nation's leading provider of diagnostic testing, information and services, providing insights that enable physicians, hospitals, managed care organizations and other healthcare professionals to make decisions to improve health. The company offers the broadest access to diagnostic laboratory testing services through its national network of laboratories and patient service centers. Quest Diagnostics is the leading provider of esoteric testing, including gene-based medical testing, and empowers healthcare organizations and clinicians with state-of-the-art connectivity solutions that improve practice management. Additional company information can be found on the Internet at: http://www.questdiagnostics.com/.
The statements in this press release that are not historical facts or information may be forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the outcome to be materially different. Certain of these risks and uncertainties are listed in the Quest Diagnostics Incorporated 2001 Form 10-K and subsequent filings.
Quest Diagnostics is a registered trademark owned by Quest Diagnostics Incorporated.
All other non-Quest Diagnostics trademarks are the property of their respective owners.
SOURCE: Quest Diagnostics Incorporated
Contact: Investors - Laure Park, +1-201-393-5030, Media - Jennifer
Somers or Gary Samuels, +1-201-393-5700, all of Quest Diagnostics