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BioView, Abbott Team on Scanning System for ALK FISH Probe

NEW YORK (GenomeWeb News) – Israel-based BioView today said that it has reached an agreement with Abbott to collaborate on development of automated digital imaging software for Abbott's Vysis ALK Break Apart FISH Probe Kit.

BioView said that it will perform studies to support regulatory approval of its Duet Automated Scanner with an indication for automated imaging and analysis of the Abbott test. In addition, it said Abbott intends to use BioView's automated scanning microscope and image analysis system for clinical trials supporting regulatory approval of end-to-end automation of the preparation, scanning, and scoring of formalin-fixed paraffin-embedded non-small cell lung cancer tissue specimens that are probed with the ALK Kit.

Following regulatory approvals the firms plan to co-market BioView technology worldwide. Further terms of the alliance were not disclosed.

The Vysis ALK Break Apart FISH Probe Kit gained US Food and Drug Administration clearance in August 2011. It detects rearrangements of the anaplastic lymphoma kinase gene in non-small cell lung cancer and is marketed for use with Pfizer's Xalkori (crizotinib) ALK-inhibitor.

BioView's Duet System already has FDA clearance for automated imaging and analysis of cells in urine specimens using the Vysis UroVysion Bladder Cancer Recurrence Kit and for FFPE breast tissue specimens probed by the Vysis PathyVision HER-2 DNA Probe Kit.

Abbott noted in a separate statement that it also plans to conduct clinical studies to develop a version of the Vysis ALK FISH kit for use with its own VP2000 Processor to automate the sample pretreatment steps.