Companies Collaborate to Detect Gene Rearrangements

According to an agreement between the two companies, BioView will perform the studies to obtain regulatory approval for its Duet Automated Scanner to include an indication for automated imaging and analysis of Abbott's Vysis ALK Break Apart FISH Probe Kit.

Abbott plans to utilize the BioView product in its own clinical trials for future regulatory approval for end-to-end automation of the preparation, scanning, and scoring of formalin-fixed paraffin-embedded (FFPE) non-small-cell lung cancer-tissue specimens, probed with the ALK Kit. After receiving regulatory approvals, the parties plan to co-promote the BioView product worldwide, in compliance with applicable regulatory rules.

The Duet System is intended for in vitro diagnostic use as tool to aid the pathologist in the detection, classification, and counting of cells of interest based on color, intensity, size, pattern, and shape. The Duet has US Food and Drug Administration (FDA; Silver Springs, MD, USA) clearances for the automated imaging and analysis of hematopoietic cells, amniotic cells, cells in urine, and FFPE breast tissue specimens.

Related Links:
BioView
Abbott
US Food and Drug Administration