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BioView Gets FDA OK for Duet System for ALK Rearrangements

NEW YORK (GenomeWeb) – BioView announced on Wednesday that the US Food and Drug Administration has cleared for marketing the firm's Duet System to detect rearrangements involving the ALK gene in non-small cell lung cancer samples.

Specifically, the system has been cleared for the qualitative detection of ALK rearrangements via fluorescence in situ hybridization in formalin-fixed paraffin-embedded NSCLC tissue specimens that are probed with the Abbott Vysis ALK Break Apart FISH Probe Kit.

The Duet System is intended for use as an aiding tool to the pathologist in the detection, classification, and counting of cells of interest based on color, intensity, size, pattern, and shape, said BioView.

The system previously was cleared by FDA for hematopoietic cells stained by Giemsa stain, Immunohistochemistry, or ISH (with bright field and fluorescent) prepared from cell suspension; amniotic cells stained by FISH; cells in urine specimens, stained by FISH using the Vysis UroVysion Bladder Cancer Recurrence Kit; and FFPE breast tissue specimens probed by the Vysis PathVysion HER-2 DNA Probe Kit.

Abbott's Vysis ALK Break Apart FISH Probe Kit received FDA 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.

Israel-based BioView inked an alliance with Abbott in late 2012, under which Abbott said that it intended 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 FFPA NSCLC specimens.