REHOVOT, Israel, September 28 /PRNewswire/ -- BioView Ltd, from Rehovot, Israel, announced today 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 (TM) System, for amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X, Y, 13, 18, and 21).
The Duet(TM) had previously received FDA clearance for hematopoietic cells stained by Giemsa stain, Immunohistochemistry or ISH (with bright field and fluorescent) prepared from cell suspension for in-vitro diagnosis use, as an aiding tool to the pathologist in the detection, classification and counting of cells of interest based on particular color, intensity, size pattern and shape.
This new application for the DUET (TM) System will now assists caregivers to diagnose and monitor patients with genetic abnormalities as well as hematological pathologies. Bioview's advanced technology rapidly links morphological analysis with FISH (Fluorescent in-situ hybridization) technology which allows the pathologist to analyze the same cell by both methods, for example, morphology and FISH staining. According to BioView, the utilization of its system generates increased information that is not provided by any other commercial technology while providing fast, accurate and highly sensitive results.
Opher Shapira, President and CEO of BioView Ltd, said, "We are pleased to have received FDA clearance for the new extended use of the Duet(TM) System on amniotic cells. In particular, we are pleased to have received clearance for the Duet to aid in the diagnosis of specific chromosomal aberrations (X, Y, 13,18 and 21). Coupled with the prior clearance of the Duet(TM) for hematopoietic cells this clearance will enable us to broaden our market penetration and firmly establish BioView as the leader in FISH automation systems worldwide."
"We intend to continue to develop future applications of other types of cells as well as for specific diseases. 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. We believe that BioView offers the only automated system that enables laboratories to perform a wide range of genetic tests based on fluorescent in situ hybridization (FISH) technology, combined with morphology or immunohistochemical staining in order to provide important genetic data to the caregiver."
About BioView Ltd.
Established in 2000, and led by an expert team of biologists, software engineers and physicists, BioView develops, manufactures and supplies cell imaging equipment, biological kits and software to medical institutes and universities. A privately owned company, BioView currently has strategic collaborations underway with international scientific leaders and institutions.
For more information about the BioView technology, and press related issues, please contact Alan Schwebel, T +972-8-936-6868, firstname.lastname@example.org or visit our website at http://www.bioview.co.il/