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Study says test is superior in detecting bladder cancer (11/3/97)

Researchers in a U.S. multi-center study led by Dr. Michael Sarosdy of The University of Texas Health Science Center at San Antonio found that the BTA *stat* Test improves detection of recurrent bladder cancer over the standard non-invasive method, cytology, according to a paper published in the September issue of *Urology*. The BTA *stat* Test was cleared by the U.S. Food and Drug Administration (FDA) in April 1997.

In the double-blinded study, 134 patient samples with histologically confirmed bladder cancer were compared using the BTA *stat* Test and urine cytology. Urine cytology involves microscopic examination of cells in patient urine and is a standard in urologic practice. The sensitivity of the BTA *stat* Test in detecting cancer at various levels of tumor stage and grade was noted as statistically superior to cytology.

Commenting on the study, Dr. Sarosdy said, "At the very least, the BTA *stat* Test should allow for the replacement of cytology in most cases, and allow decisions previously based on cytology to be made more quickly. For a physician's office or hospital-based urology practice, using the BTA *stat* Test means clinical decisions can be made before cystoscopy, rather than after."

The BTA *stat* Test is a rapid, single-step immunoassay. The disposable test device contains two monoclonal antibodies that detect the presence of a newly identified human Complement Factor H-related protein (hCFHrp). The antigen is related, but not identical to, human Complement Factor H (hCFH).

Like hCFH, the bladder tumor-associated antigen detected by the BTA *stat* Test may confer a selective growth advantage to cancer cells by protecting them from the patient's own immune system. To use the BTA *stat* Test, five drops of urine are placed into the sample well of the test device, and positive or negative results are provided in five minutes.

The study also noted that the BTA *stat* Test is not only simpler and faster than cytology, but is simpler than the original Bard(r) BTA(r) Test. "in short, the BTA *stat* Test takes fewer steps and less time than the original test," said Dr. Sarosdy. The FDA cleared Bard's first BTA Test, a rapid multi-step test for bladder tumor-associated analytes, in 1995. The BTA *stat* Test and original Bard BTA Test remain the leading point-of-care and laboratory assays for the detection of tumor-related recurrent bladder cancer.

The study concludes that the BTA *stat* Test's sensitivity and rapid results are likely to enhance the disease management process, and states that "the BTA *stat* Test is significantly superior to voided urinary cytology in the detection of recurrent bladder cancer in patients undergoing surveillance for that disease."

Bladder cancer is one of the most common forms of cancer in the United States. Some 53,000 Americans are diagnosed with bladder cancer each year, and approximately 500,000 people are routinely monitored for the disease in the United States. The cancer is most common among people over the age of 50, smokers and workers exposed to chemicals in the rubber, leather tanning, metal and dye industries. Bladder cancer is one of the most highly curable types of cancer, if detected early. However, its recurrence rate is between 50 and 80 percent, making life-long monitoring an essential health maintenance component.

For copies of the paper titled "Improved Detection of Recurrent Bladder Cancer Using the Bard BTA *stat* Test" or other studies on the BTA *stat* Test, visit the BTA Web site at www.barddiagnostics.com.

Dr. Sarosdy is professor and chief of the urology division in the Health Science Center's department of surgery. The University of Texas Health Science Center at San Antonio is one of 15 components in The University of Texas System.

Contact: Will Sansom (210) 567-2570 or Wendy Johnson, EvansGroup Public Relations (206) 270-4655