Applied Spectral Imaging (ASI) has announced that its GenASIsTM applications comply with CE-IVD requirements under the European Directive on In Vitro Diagnostic Medical Devices, for automated analysis with the IQFISH lung cancer panel on Dako Omnis (comprising of ALK, ROS1, RET and MET IQFISH probes) of Agilent Technologies Inc.
This clearance delivers to pathology labs the best of both worlds – ASI’s unmatched workflow efficiencies and enhanced accuracy, with Agilent’s new high-quality IQFISH lung cancer panel. The result ensures optimal performance and standardization of FISH analysis, without compromising the laboratories’ certification standards.
“This latest CE-IVD conformity is evidence of our commitment to improve patient care. Laboratories can now have a fully optimized FISH workflow with greater image quality, that negates the time-consuming and costly need for internal validation,” said Limor Shiposh, chief executive officer of ASI. “Being recognized for our industry-leading FISH imaging platforms, ASI is proud to be the first to market imaging platforms that are CE-IVD conformed with Agilent’s new IQFISH lung cancer panel. We are certain that this solution will rapidly become the new gold standard for pathologists in Fluorescence-based molecular analysis”, Mrs. Shiposh added.