Automated Urine Test Diagnosis Bladder Cancer

oncoFISH bladder test 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.

Ikonisys, Inc. (New Haven, CT,USA), a developer of automated cell-based diagnostic products, announced that the United States Food and Drug Administration (FDA) cleared the company's oncoFISH bladder diagnostic application for marketing in the United States. In conjunction with the company's Ikoniscope robotic digital microscopy platform, oncoFISH bladder enables automated testing of cells found in urine specimens.

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 CEO 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.

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.

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 for cancer diagnostics and monitoring and fastFISH for the prenatal detection of genetic disorders, which are designed to run on the company's robotic digital microscopy platform




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