Ikonisys Receives FDA Clearance For Automated Bladder Cancer Test

Ikonisys Inc., a developer of automated cell-based diagnostic products, today announced that the United States Food and Drug Administration (FDA) cleared the Company's oncoFISH(TM) bladder diagnostic application for marketing in the United States. In conjunction with the Company's proprietary Ikoniscope(R) robotic digital microscopy platform, oncoFISH bladder enables automated testing of cells found in urine specimens to aid in the detection of bladder cancer.

"oncoFISH bladder is expected to significantly reduce the time required to process test results while improving the accuracy of bladder cancer diagnosis, and we are prepared for its immediate launch," said Petros Tsipouras, M.D., Chairman and Chief Executive Officer of Ikonisys. "We believe the Ikoniscope and associated oncoFISH and fastFISH automated diagnostic applications are an economical and dependable solution to subjective sample analysis, protracted turnaround times for test results, and the acute laboratory shortage of trained technical personnel."

Ikonisys' suite of diagnostic products automates a standard but time-consuming laboratory technique, fluorescence in situ hybridization (FISH), which identifies chromosome aberrations associated with various diseases. oncoFISH bladder detects aberrations for chromosomes 3, 7, 9, and 17 in cells found in urine sediment to aid in the initial diagnosis of bladder cancer in patients with hematuria (blood in the urine) and the subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

About Bladder Cancer

Bladder cancer is one of the most common cancers in the United States. More than 61,000 new cases of bladder cancer were diagnosed in 2006, according to the American Cancer Society, and most patients are monitored for recurrent disease.

About Ikonisys

Ikonisys develops, commercializes and markets a robotic digital microscopy platform and proprietary diagnostic applications that increase throughput and improve the accuracy of diagnostic screening in the areas of cancer diagnosis and management, prenatal detection of genetic disorders, and fertility. The Company has developed two product lines, oncoFISH(TM) for cancer diagnostics and monitoring and fastFISH(R) for the prenatal detection of genetic disorders, which are designed to run on the company's proprietary Ikoniscope(R) robotic digital microscopy platform. Additional information about Ikonisys and the Company's products can be found at http://www.ikonisys.com.

Ikonisys Inc.
http://www.ikonisys.com