FDA clears Ikonisys' oncoFISH her2 breast cancer test
This article was originally published in Clinica
The FDA has granted 510(k) clearance for Ikonisys' oncoFISH her2 test, an automated microscopy system to determine HER2 status in breast cancer patients. The test runs on the firm's CellOptics platform and features the Ikoniscope digital microscope system, and analyses breast cancer specimens processed with Abbott's PathVysion HER2 DNA Probe Kit. Establishing a patient's HER2 status is important to determine whether they can receive Roche's HER2-targeting drug Herceptin (trastuzumab). Fluorescence in situ hybridisation (FISH) uses fluorescent probes to detect specific DNA sequences, which are then visualised with a fluorescent microscope. New Haven, Connecticut-based Ikonisys says that its system helps laboratories standardise their test procedures and decreases waiting time for results.
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