BioSpace Collaborative

Academic/Biomedical Research
News & Jobs
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
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
  C2C Services & Suppliers™
Europe
Asia

DIVERSITY

PROFILES
Company Profiles

INTELLIGENCE
Research Store

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

 News | News By Subject | News by Disease News By Date | Search News
Get Our Industry eNewsletter FREE email:    
   

FDA Clears Applied Spectral Imaging (ASI)'s GenASIs Advanced Imaging for HER-2/neu Analysis


2/21/2012 6:47:41 AM

CARLSBAD, Calif.--(BUSINESS WIRE)--Applied Spectral Imaging (ASI) announces that ASI’s GenASIs automated scanning and image analysis system for detection and quantifying chromosome 17 and the HER-2/neu gene has been cleared by the United States Food and Drug Administration (FDA) for marketing in the US.

Detection and analysis is concluded via Fluorescence In Situ Hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens.

GenASIs Scan and Analysis is intended for in-vitro diagnostic use as an adjunctive automated enumeration tool to assist the cytogenetics and pathologist to detect amplifications of the HER-2/neu gene in human breast cancer specimens.

With the introduction of GenASIs 7, ASI has broadened its FDA cleared portfolio and now provides 3 major FDA cleared tests: an aiding tool in breast cancer - HER2/neu FISH, CEP XY used to assess effectiveness of bone marrow transplantation in opposite-sex transplants and UroVysion for detection of cells in urine specimens from persons suspected of having bladder cancer.

ASI’s manual and automated scanning platform and image analysis systems enable laboratories to provide highly reliable Her2/neu FISH test results quickly and cost-effectively.

Limor Shiposh, ASI’s Chief Executive Officer said, “We are pleased to have received an additional and important FDA clearance. We plan to expand our portfolio of FDA cleared tools in our GenASIs platform to better serve our customers in achieving more accurate clinical results, quicker and more cost effectively. I am confident that this addition will help further establish ASI as the world leaders in automated and manual FISH imaging and analysis.”

About ASI

Applied Spectral Imaging (ASI) makes patient care better through advanced biomedical imaging.

The GenASIs Automated Imaging Platforms for Genetic and Pathological Analysis are the foundation of ASI’s offering. With superior imaging and analysis capabilities, ASI provides state of the art diagnostic aids, offering cytogeneticists and pathologists accurate analysis. GenASIs enables automated tissue analysis for primary diagnostics, with reproducible and reliable results. GenASIs Hyperspectral with HiSKY® Probes adds a new dimension to biomedical image analysis.

GenASIs is FDA cleared for FISH clinical applications such as UroVysion, HER2/neu, CEP XY and Karyotyping. ASI complies with major regulatory requirements and international quality standards.

ASI is the industry's leading microscopy imaging solution provider since 1993, with over 30 registered patents in the US, Europe and Japan and over 2,500 systems deployed worldwide. With worldwide offices in the US, Europe and Asia, ASI has built a global network of over 50 distributors.

Contacts

Applied Spectral Imaging

Mr. Dror Armon, Sales Director

Phone: +1(800) 611-3466

E-mail: Dror@spectral-imaging.com

www.spectral-imaging.com


Read at BioSpace.com
Read at SelectScience

   

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

//-->