BioView receives FDA clearance for ALK FISH application
BioView is pleased to announce that the United States Food and Drug Administration (FDA) cleared for marketing in the United States its automated scanning microscope and image analysis system, the Duet™ system, to qualitatively detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens, probed with the Abbott Vysis® ALK Break Apart FISH Probe Kit. The Duet™ is to be used as an adjunctive automated enumeration tool, in conjunction with manual review of the digital image. The Duet™ system is intended for in-vitro diagnostic 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.
The Duet™ had previously received FDA clearances for the following applications:
- Hematopoietic cells stained by Giemsa stain, Immunohistochemistry or ISH (with bright field and fluorescent) prepared from cell suspension
- Amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X, Y, 13, 18 and 21)
- Cells in urine specimens, stained by FISH using the Vysis UroVysion™ Bladder Cancer Recurrence Kit FFPE breast tissue specimens probed by the Vysis® PathVysion™ HER-2 DNA Probe Kit
- FFPE breast tissue specimens probed by the Vysis® PathVysion™ HER-2 DNA Probe Kit