Applied Spectral Imaging (ASI) announced today 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. (NYSE: A).
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.
ASI is a global leader in the development of imaging solutions, supporting fluorescent, brightfield and spectral image-acquisition, for various pathology tests, FISH and karyotyping.
The GenASIs™ automated imaging platforms for pathology and genetic analysis provide advanced diagnostic aids for pathologists and cytogeneticists, with reproducible and standardized results. GenASIs platforms support manual and automatic scanning for a wide range of workflows and applications, to best suit the needs, size and budget of any lab.
ASI’s GenASIs applications are FDA cleared for BandView, FISHView, CEP XY, UroVysion, ALK, HER2/neu FISH and IHC Family for: HER2, ER, PR and Ki67.
ASI serves clinical laboratories, life science companies and research institutions in over 50 countries.
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Applied Spectral Imaging
Phone: +1 (760) 929-2840