Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.US-based Ikonisys, a provider of cell-based diagnostic solutions, has received clearance from the FDA for its oncoFISH her2 breast cancer test.
Subscribe to our email newsletter
Ikonisys said that oncoFISH her2 is a fully automated microscopy application for the determination of HER2 status in human breast cancer specimens processed with Abbott’s PathVysion HER2 DNA probe kit.
The test runs on the company’s CellOptics platform, featuring the Ikoniscope, a proprietary high-throughput, digital microscope, and provides ‘walk-away’ automated testing of the HER2 gene to provide an early and accurate indication for gene amplification, according to Ikonisys.
Petros Tsipouras, chairman and CEO of Ikonisys, said: “With this test, laboratories and hospitals will have an economical and accurate method for automating their FISH testing of HER2 breast cancer. This will help them to standardize their diagnostic testing procedures, decrease the wait time for test results and, more importantly, help labs to compensate for the nationwide shortage of lab technicians by enabling them to best maximize their time.”