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

   

Abacus Diagnostica Receives CE Mark for Its Rapid Direct PCR Test for Toxigenic Clostridium Difficile


11/19/2012 6:55:59 AM

TURKU, Finland, November 19, 2012 /PRNewswire/ -- Abacus Diagnostica Ltd announced that it has received the CE mark for the GenomEra™ C. difficile assay for the detection of toxin-producing Clostridium difficile directly from stool samples. C. difficile is the leading cause of infectious nosocomial diarrhea in Europe and North America.

(Photo: http://photos.prnewswire.com/prnh/20121119/574465 )

Rapid changes in the epidemiology and increasing incidence have taken the focus on methods to diagnose toxigenic C. difficile faster and more efficiently. Accurate and rapid diagnosis of C. difficile infection is crucial for patient care but also for preventing transmission and reducing the overall disease burden.

The GenomEra C. difficile assay is the newest test of Abacus Diagnostica's expanding line of easy-to-use and cost-efficient molecular diagnostics products. The C. difficile test is extremely simple to perform directly from stool specimen through a straightforward sample preparation process without extraction, heating or centrifugation steps. The assay is built on rapid and reliable target amplification and end-point detection technology that allows for high quality results in 50 minutes.

"Abacus is committed to providing a continuum of diagnostic products for key infectious diseases to meet the needs of various laboratory settings," said Tom Palenius, CEO of Abacus Diagnostica. "Along with our earlier CE marked MRSA/SA assays this PCR test will help to meet the testing and resource challenges of many different types of labs. During next year we will continue to expand our molecular test offering for critical blood stream and perinatal infections."

About the GenomEra CDX™ System Molecular Diagnostic Platform

The GenomEra CDX system is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination. The GenomEra CDX system is designed for clinical routine use for identification of target nucleic acid sequences directly from crude clinical samples and delivering reliable non-confusing answers in less than in one hour. The GenomEra CDX system combines minimal sample preparation with rapid and high-performing PCR (polymerase chain reaction) amplification and end-point detection for fully integrated and automated nucleic acid analysis. GenomEra CDX system is the first commercial homogenous PCR platform to use thermally stable, intrinsically fluorescent time-resolved fluorometric (TRF) labels combined with a proprietary assay and measurement technology with effective elimination of background effects originating from e.g. crude clinical samples.

About Abacus Diagnostica

Abacus Diagnostica Oy is a Finnish ISO9001:2008 and ISO13485:2003 certified IVD company specialized in rapid DNA testing. Our proprietary, fully automated GenomEra CDX™-platform makes it possible to perform high-performance DNA-based testing even outside a specialized laboratory and by personnel without experience in molecular biology.

The company's business focus is in Healthcare Associated Infections, Bloodstream Infections and Perinatal Diagnostics. The Abacus GenomEra CDX system is currently available in Europe with CE-IVD mark. Applications include a test panel for MRSA/SA for various matrixes including blood culture for sepsis care, and the Clostridium difficile test for stool samples. Next tests in pipeline are Streptococcus pneumoniae and Streptococcus agalactiae (GBS).

http://www.abacusdiagnostica.com



Read at BioSpace.com

 
 

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