Cangen Biotechnologies Announces Non-Invasive Bladder Cancer Diagnostic Study; Assay is First DNA-Based Early Detection for Bladder Cancer.

BETHESDA, Md. -- Cangen Biotechnologies, Inc. (www.cangenbio.com) announced today the initiation of enrollment of patients in a Phase 3 study to evaluate a diagnostic test for the early detection of bladder cancer. Cangen's non-invasive test detects cancer by identifying genetic alterations in microsatellite DNA in urine. The validation study for detection of microsatellite instability in bladder cancer as markers for early detection and recurrence of bladder cancer was initiated and is conducted by the Early Detection Research Network (EDRN), a National Cancer Institute (NCI) consortium for early detection and risk assessment of cancer.

The study has been designed to test the assay's effectiveness in detecting recurrent cancer in 300 bladder cancer patients with the goal of presenting the assay for evaluation by the FDA. The test is Cangen's first application of its platform technology to detect cancer through the identification of genetic alterations in micro-satellite DNA. The primary funding for this project is through the EDRN and the NCI. Cangen, which holds the license for developing diagnostic tests using microsatellite analysis from Johns Hopkins Medical Institute, is collaborating with the EDRN and NCI on the project.

"Cangen has worked closely with the NCI, the Early Detection Research Network (EDRN) and the Food and Drug Administration (FDA) to assure that the study protocol and results meet FDA requirements for evaluation of its cancer diagnostic," stated Dr. Frank E. Young, former FDA Commissioner and Cangen's Board Chairman.

Richard A. Silfen, President and Chief Financial Officer, commented, "Cangen is focusing on an array of cancer diagnostics that will make a difference in the selection of therapeutic regimes. Cangen owns the worldwide rights to develop a number of diagnostic applications based on genetic alterations in microsatellite DNA through a technology license from Johns Hopkins University, the patent holder."

The bladder cancer assay is based on analysis of DNA in urine that is amplified by the polymerase chain reaction (PCR) and analyzed by capillary electrophoresis. Silfen noted that, "this is the first diagnostic application of DNA based assays developed by Cangen under its license."

"If successful, the study will result in a non-invasive, painless cost-effective test for identifying recurrent cancer in thousands of bladder cancer patients," stated Robert G. Kalik, Chief Operating Officer of Cangen.

About Cangen Biotechnologies

Cangen Biotechnologies, Inc. is a leader in the development of non-invasive diagnostic tests for the early detection of cancer and other technologies designed to enhance the selection of cancer therapeutic regimes. The diagnostic tests being developed by Cangen Biotechnologies are based on one of its two platform technologies, one of which analyzes micro-satellite DNA and the other of which analyzes arrays of protein markers. Cangen Biotechnologies also is developing technology to enable chemo-sensitivity analysis designed to enhance the selection of cancer therapeutic regimes using its protein based platform technology. Cangen Biotechnologies is based in Bethesda, MD, has laboratories in Baltimore, MD and also has operations in Seoul, Korea. For more information call 240-644-0240 or visit www.cangenbio.com.