PITTSBURGH, February 15, 2000 – Researchers at the University of Pittsburgh Department of Urology and the University of Pittsburgh Cancer Institute (UPCI) have developed a novel and highly specific early bladder cancer detection technology, which was licensed recently by Eichrom Technologies, Inc., in Darien, IL.

Robert Getzenberg, Ph.D., director of research of the department of urology and co-director of the Prostate and Urologic Cancer Center and associate professor of urology, pathology and pharmacology, led a group of researchers in identifying six bladder tissue specific proteins (BLCA 1-6) from inside the nucleus of bladder cancer cells that are not found in other types of cancers such as prostate, breast, kidney and cervical cancers.

In a study of 55 patients with histologically proven bladder cancer, BLCA-4 was found to be 96.4 percent sensitive and 100 percent specific for distinguishing patients with bladder cancer from those without the disease. Moreover, BLCA-4 was detected throughout the bladder in patients with bladder cancer, indicating that it may be an early marker of the disease.

"If these same results are proven in clinical trials, early detection of bladder cancer may be dramatically improved and significantly less invasive, making BLCA-4 the first marker available to screen individuals specifically for bladder cancer," Dr. Getzenberg said.

The results to date show that BLCA-4 will be significantly more accurate and specific than any of the other urine-based tests currently available for detecting bladder cancer. Because of this, Eichrom Technologies has licensed this technology to develop an ELISA-based quantitative assay and qualitative one-step rapid test, similar to the type of assay used in home pregnancy tests.

"This study is just one example of the direction towards developing more highly specific and sensitive tumor markers," said Tim Barder, Ph.D., vice president of research and commercial development at Eichrom Technologies. "This study could set the benchmark for all other types of biomarkers, either commercially available or under development, for diagnosis and management of bladder cancer."

Plans to enter into a multi-site clinical trial in 2000 to validate the use of BLCA-4 in the diagnosis and monitoring of bladder cancer are underway. This trial will be coordinated by Badrinath Konety, Ph.D., in the department of urology.