Automated bladder cancer test receives FDA clearance

Ikonisys Inc. has received FDA approval to market the oncoFISH bladder diagnostic application in the United States. In conjunction with the company’s proprietary Ikoniscope 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 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 and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

The automated diagnostic platform is expected to significantly reduce the time required to process test results while improving the accuracy of bladder cancer diagnosis, according to the manufacturer.