"This is a small study population," cautions study co-author Dario Altieri, MD, "and the results have to be confirmed in thousands of patients. But this gene is expressed only in specific cancer tissues and never in normal tissues. We might eventually have a very easy, very inexpensive urine test for bladder cancer." Altieri is professor of pathology at the Yale University School of Medicine.

The Yale group focused on survivin because the gene interferes with a type of normally-occurring cell death called apoptosis. (The name survivin refers to the cell?s ability to survive by avoiding cell death.) Without the normal chemical signals instructing the cell to die, cells continue to reproduce uncontrollably, forming cancers. Discovered just three years ago, survivin has been found in high levels in cancers of the bladder, breast, colon, brain, lung, lymphatic system, and other tissues. But, it is not detectable in normal tissues, says Altieri.

Several tests are currently used for bladder cancer diagnosis but each has its drawbacks. The two most common tests are cystoscopy and urine cytology, and they are frequently used in combination. In a cystoscopy, a doctor views the lining of the bladder through a hollow, lighted tube inserted into the urethra. Cystoscopy is very accurate for most types of bladder cancer but is also expensive and uncomfortable. Urine cytology involves using a microscope to find cancer cells in urine specimens. It is painless, but may miss some cancers, especially low grade or slow-growing ones, and its accuracy depends on the skill of the technologists and pathologists looking through the microscope.

The survivin test results were highly encouraging, says Altieri. There were no false negatives, meaning that survivin was detected in the urine of all the patients with bladder cancer. Also, patients with the most serious forms of bladder cancer (flat carcinoma in situ and high grade carcinomas) had higher urine survivin levels than patients with more favorable types (low-grade papillary tumors).

"We''ve needed a better marker for bladder cancer," says Ralph Vogler, MD, scientific programs director for the American Cancer Society. "The only way to follow patients until now has been repeated cytoscopy, which is not a pleasant process. If this test survives confirmation studies, it is going to make for much easier follow-up and treatment for patients."

Altieri says the Yale group hopes to include their survivin test in the National Cancer Institute''s Early Detection Study so that it can be tested in thousands of patients. If the test survives the challenge, a simple, automated version might be developed that could be processed in doctors? office labs.