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:5/4/2017)... , May 4, 2017  Fortuna Fix Inc. (" ... to be the first to eliminate the need for embryonic ... cells to treat neurodegenerative diseases. Fortuna ... with Professor Michael Fehlings , MD, PhD; Father ... , MD, MPH; and Professor James Giordano , PhD. ...
(Date:5/4/2017)... Israel , May 4, 2017  DarioHealth Corp. ... mobile health and big data solutions, today announced that ... A&D Company, and STI Technologies Limited to lower diabetes ... immediately. Through STI,s innoviCares card, which is available throughout ... , DarioHealth customers will be eligible for additional savings ...
(Date:5/3/2017)...  Kalorama Information notes that transplant diagnostics is ... and this is projected to continue to 2021. ... or bone marrow transplants require histocompatibility between the ... this task. This according to a new report ... various PCR-based methodologies, Sanger sequencing and NGS used ...
Breaking Medicine Technology:
(Date:5/26/2017)... (PRWEB) , ... May 26, 2017 , ... ... met this week to review more than eighty-nine grant submissions all vying ... emerging young scientists in the Parkinson’s field.     , The American Parkinson Disease Association ...
(Date:5/26/2017)... ... , ... Amir Qureshi, MD is the first physician in Arkansas to implant ... The Nuvectra™ Algovita SCS System has been FDA approved as a treatment option for ... to introduce the most powerful SCS system and the only stretchable lead on the ...
(Date:5/26/2017)... (PRWEB) , ... May 26, 2017 , ... ... premium delicatessen foods, is sharing bold recipes for Memorial Day entertaining that are ... menus. , “Boar’s Head fresh sliced meats and cheeses featured in these ...
(Date:5/26/2017)... (PRWEB) , ... May 26, 2017 , ... After raising ... Antzy Top gadget will continue to be available at a discounted crowdfunding price on ... with stress wherever they are, I also wanted to bring a fidget toy to ...
(Date:5/26/2017)... ... ... Lowe acts as host and helps educate and inform the public using the “Informed” ... reconnect with America as it explores some of the best places to hike and ... inventive new place for a family vacation, and have discovered hiking. Many will agree ...
Breaking Medicine News(10 mins):