FISH Scanning for Bladder Cancer

The system has been cleared by the U.S. Food and Drug Administration (FDA).

Specifically, this Duet system is for use in detecting, classifying, and counting of cells in urine specimens that are stained by fluorescence in situ hybridization (FISH) using the UroVysion bladder cancer recurrence kit of Vysis, Inc. (Downer's Grove, IL, USA). The kit monitors chromosomal aberrations 3, 7, 17, and 9p21 locus. The Duet system is the product of BioView Ltd. (Rehovet, Israel).

The Duet was previously cleared by the FDA for hematopoietic cells stained by Giemsa stain, immunohistochemistry, or in situ hybridization (ISH) prepared from cell suspension and amniotic cells stained by FISH, using direct labeled DNA probes for chromosomes X, Y, 13, 16, and 21.

"Our commitment is to offer the most advanced image analysis systems to assist the pathologist and cytogeneticist in classifying and counting cells of interest, utilizing our advanced algorithms for both brightfield and fluorescent scanning,” noted Opher Shapira, president and CEO of BioView. "We believe that BioView offers the only automated system that enables laboratories to perform a wide range of genetic tests based on FISH technology, combined with morphology or immunohistochemical staining in order to provide important genetic data to the caregiver.”





Related Links:
Vysis
BioView