Ikonisys bladder cancer test
This article was originally published in Clinica
Ikonisys has received US FDA 510(k) market clearance for its automated bladder cancer test, oncoFISH, which, when used with the firm's robotic digital microscopy platform, Ikoniscope, enables faster testing of cells in urine to help detect the disease. Ikonisys' technology automates a standard but time-consuming laboratory technique, fluorescence in situ hybridisation (FISH), which identifies chromosome aberrations associated with various diseases. oncoFISH bladder detects aberrations for chromosomes 3, 7, 9, and 17 in cells in urine sediment to aid in the initial diagnosis of bladder cancer in patients with haematuria and the subsequent monitoring for tumour recurrence in patients previously diagnosed with bladder cancer. The test is expected to improve diagnostic accuracy, said the New Haven, Connecticut firm.