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ASI Receives CE-IVD Mark for Automated Image Platform with Lung Cancer Panel

NEW YORK (360Dx) – Applied Spectral Imaging said today that it has received CE-IVD clearance for the marketing of its GenASIs automated imaging platform with Agilent Technologies' Dako Omnis IQFISH lung cancer panel.

Because of the clearance "laboratories can now have a fully optimized FISH workflow with greater image quality, that negates the time-consuming and costly need for internal validation,” ASI CEO Limor Shiposh said in a statement.

He said that he believes the solution "will rapidly become the new gold standard" for pathologists doing fluorescence-based molecular analysis.

GenASIs platforms are used by pathologists and cytogeneticists with any brand of brightfield or fluorescence microscope, and they support manual and automatic scanning for a wide range of workflows and applications, ASI said.

The IQFISH panel for lung cancer is a set of oligonucleotide-based FISH probes used for detecting rearrangements involving the ALK, ROS1, and RET genes, and for detecting MET gene amplification by fluorescence in situ hybridization. The panel uses oligonucleotide-based SureFISH technology with formamide-free IQFISH fast hybridization buffer, and it allows labs to simultaneously stain IHC and FISH slides, and enables multiple FISH slides to be processed in just four hours, Agilent said.

In April 2016, Agilent and ASI signed a co-marketing agreement for fluorescent in situ hybridization products. The firms said that under the terms of the agreement, they would jointly market ASI's GenASIs imaging platforms with Agilent's FISH products, including the Dako Omnis instrument for automated sample processing.