Navigation Links
IntelligentMDx Announces CE-Marking of a new high-throughput test for Group B Streptococcus intended to improve women's health and prenatal care
Date:5/15/2012

CAMBRIDGE, Mass., May 15, 2012 /PRNewswire/ -- IntelligentMDx (IMDx) announced today that it has obtained CE-marking for a new automated, high-throughput, qualitative in vitro diagnostic test designed for the rapid detection of Group B Streptococcus (GBS) for use in screening pregnant women and those in labor who may be infected with the pathogen. GBS is responsible for life-threatening bacterial infections in newborns, including sepsis, meningitis, and pneumonia. The IMDx™ GBS for Abbott m2000™ test utilizes real time PCR, operates on the Abbott m2000 system and addresses the needs of hospitals to rapidly screen large numbers of patients for GBS and make quick informed decisions about antibiotic treatment.

(Logo: http://photos.prnewswire.com/prnh/20120306/NE63745LOGO )

The IMDx GBS for Abbott m2000 test offers robust and accurate detection of GBS from both direct swabs and enriched culture broth samples.  With this test, results for up to 48 patient samples can be obtained simultaneously in approximately 5 hours or less. When compared against traditional culture methods, the IMDx GBS for Abbott m2000 test exhibits 95.5% sensitivity and 98.3% specificity with direct swabs and 100% sensitivity and 100% specificity with enriched culture broth samples.

"At IMDx we strive to develop tests that will address the specific needs of target communities," says Alice Jacobs, MD, Chairman & CEO of IMDx. "Testing for GBS is a critical step in eliminating the incidence of newborn infection. The IMDx GBS for Abbott m2000 assay is intended to improve women's health and prenatal care by providing physicians with the confidence to make intelligent treatment choices for their patients."

The IMDx GBS for Abbott m2000 assay is the third CE-marked test developed under a multi-year distribution agreement between IMDx and Abbott whereby IMDx designs, develops, obtains regulatory clearances, and manufactures assays for the Abbott FDA cleared m2000 instrument.   In addition to the new GBS assay, the IMDx CE-marked test menu for use on the Abbott m2000 system includes real-time PCR assays for the detection of vancomycin-resistant enterococci (VRE) and toxigenic C. difficile.

*The IMDx GBS for Abbott m2000 assay is CE-marked and not available for sale in the U.S. or Canada.

About IMDx

Based in Cambridge, MA, IMDx (www.IntelligentMDx.com) is an innovative company that designs, develops and manufactures molecular diagnostic products. IMDx has developed molecular solutions that are clinically impactful and competitively differentiated for a range of disease areas for current and next generation systems, including targets in infectious diseases, oncology and genetics. IMDx's expertise spans evolutionary biology, bioinformatics, microbiology, chemistry and molecular biology. These capabilities are harnessed by IMDx's proprietary bioinformatics and product development processes allowing for the rapid design and development of tests to meet clinical needs.

Contact:
Renda Hawwa
(617) 871-6405
rhawwa@intelligentmdx.com


'/>"/>
SOURCE IntelligentMDx
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. IntelligentMDx (IMDx) Introduces a CE-Marked Automated Molecular Test for the Detection of Vancomycin Resistance Genes vanA and vanB Most Commonly Found in Vancomycin-Resistant Enterococci
2. Frost & Sullivan Recognizes IntelligentMDx for Its Commitment to the Advancement of Healthcare and Diagnostics
3. Verification Studies of IntelligentMDxs Proprietary Molecular Diagnostic Assay Process Have Been Completed
4. Cardium Announces Agreement With UK-Based Angel Biomedical For Excellagen Supply And Planned European Market Expansion
5. Telik Announces the Publication of Two Reports in the Journal Of Hematology & Oncology Describing the Results of a Clinical Study of Telintra® in Combination With Revlimid® and a Genomic Study Designed to Identify Genes That Predict Response to Teli
6. Adamas Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA for Arimenda™
7. Veeva Systems Announces Dramatic Growth in Europe
8. Celleration, Inc. Announces First Patient Enrollment in In-Balance VLU Randomized Control Trial
9. Echo Therapeutics Announces First Quarter 2012 Financial Results
10. UBM Canon, the Global MedTech Authority, Announces Strategic Alliance with ITG Market Research, a Preeminent Industry Research Organization
11. Viztek Announces Availability of Opal-Mammo Integrated Mammography Suite - Complete Womens Health Package Combines PACS and Tracking Software
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/17/2017)... GRAND RAPIDS, Mich. , Jan. 17, 2017 ... of Richard M. Erwin as Vice ... Catalyst Pharmaceuticals, where he was Executive Director, Clinical Project Management. ... with over 25 years of experience in global ... a string of successful growth-stage clinical operation build-outs ...
(Date:1/17/2017)...  Bayer today announced the appointment of Dr. Carsten ... Americas, comprising the United States , ... . In this role, Dr. Brunn will report to ... of Bayer AG and President of the Pharmaceutical division. ... the pharmaceutical industry and I,m delighted to have him lead ...
(Date:1/16/2017)... 2017 Research and Markets has announced the ... report to their offering. ... Global multiple myeloma drugs market to grow at a ... report covers the present scenario and the growth prospects of the ... size, the report considers the revenue generated from the sales of ...
Breaking Medicine Technology:
(Date:1/17/2017)... , ... January 17, 2017 , ... A prescription medication ... of the fourth Cradle to Cradle Product Design Challenge , the Cradle ... a series of six circular design challenges scheduled to run through early 2018. The ...
(Date:1/17/2017)... ... January 17, 2017 , ... Wettstein ... to families and business professionals throughout central Colorado, is joining local nonprofit Aurora ... The Aurora Warms The Night organization is committed to breaking the cycle of ...
(Date:1/17/2017)... ... January 17, 2017 , ... Seceon , the ... in real-time, today announced a strategic partnership with TechLab Security, a ... Seceon partners, TechLab Security has become a strategic partner and a value added ...
(Date:1/17/2017)... New York, NY (PRWEB) , ... January 17, ... ... of Inc. Magazine’s fastest-growing private companies and ranked among the top US security ... first Board of Directors. This announcement brings a year-long independent board nomination ...
(Date:1/17/2017)... ... January 17, 2017 , ... ... the Montclair State University’s Athletic Training Education program forged a relationship built upon ... Education Program, which is consists of both student members and certified members ...
Breaking Medicine News(10 mins):