BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

FDA Clears BioView Duet(TM) System For Automated FISH Scanning Of Amniotic Cells


10/19/2005 5:09:13 PM

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, alan@bioview.co.il or visit our website at http://www.bioview.co.il/

BioView Ltd.

CONTACT: Dr. Alan Schwebel, T +972-8-936-6868



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES