Navigation Links
IntelligentMDx Receives FDA Clearance for IMDx C. difficile for Abbott m2000 Assay, Completes Move of Corporate Headquarters to Waltham
Date:11/12/2013

WALTHAM, Mass., Nov. 12, 2013 /PRNewswire/ -- IntelligentMDx announced today that it has received FDA clearance for the IMDx C. difficile for Abbott m2000 assay which detects nucleic acids encoding the toxin A gene and toxin B gene sequences of toxigenic strains of Clostridium difficile in human liquid or soft stool specimens collected from patients suspected of having Clostridium difficile associated disease.  This is the third test from IMDx to receive FDA clearance within three months for use on Abbott's fully-automated m2000 system and follows clearances of the IMDx VanR for Abbott m2000 and IMDx Flu A/B and RSV for Abbott m2000 assays.

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

C. difficile is the leading cause of hospital-acquired diarrhea and may cause more severe intestinal conditions such as pseudomembranous colitis. According to the CDC, C. difficile infection is linked to approximately 14,000 deaths in the United States annually.* Effective molecular diagnostic tests for early detection of C. difficile remain critical to help control the spread of infection and the threat of more serious complications.

Analytical reactivity studies demonstrated that the IMDx C. difficile for Abbott m2000 assay is capable of detecting the 31 different toxigenic C. difficile strains that were tested. These strains represent the global diversity of C. difficile strains, including NAP1, and tcdB-variant strains, such as 1470.

"FDA clearance of the IMDx C. difficile for Abbott m2000 assay comes at a pivotal time when incidence of C. difficile infection and severity in both hospital and community settings is increasing," says Dr. Alice Jacobs Nesselrodt, Chairman & CEO of IMDx. "Detection of a wide variety of C. difficile strains, including hypervirulent strains, by the IMDx C. difficile for Abbott m2000 assay will help ensure that a high number of cases of C. difficile are detected in a timely manner, regardless of the source of infection."

The IMDx C. difficile for Abbott m2000 assay is part of a broad real-time PCR test menu designed, developed, and manufactured for use on Abbott's RealTime m2000 system under a multi-year distribution agreement with Abbott.

IMDx also recently completed the move of its corporate headquarters, manufacturing and R&D operations to its new facility in Waltham, Massachusetts. The design-built facility features BL-2 laboratory space and GMP manufacturing in compliance with FDA and ISO 13485 standards.

*MMWR Weekly Report "Vital Signs: Preventing Clostridium difficile Infections" March 9, 2012 / 61(09); 157-162

About IMDx

Based in Waltham, MA, IMDx (www.IntelligentMDx.com) designs, develops and manufactures platform-agnostic, regulatory-cleared molecular diagnostic tests that enable partners to more rapidly and efficiently expand test menus. Beyond growing its portfolio of assays for infectious disease, IMDx is pursuing new targets in companion diagnostics, oncology and human genetics, as well as next generation instrument systems. IMDx facilities are ISO 13485:2003 certified and all products are developed and manufactured within a regulatory compliant (FDA QSR, CE-IVDD and cGMP) environment.

Renda Hawwa
617-871-6405


'/>"/>
SOURCE IMDx
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. IntelligentMDx Announces CE-Marking of a new high-throughput test for Group B Streptococcus intended to improve womens health and prenatal care
2. IntelligentMDx gibt CE-Kennzeichnung eines Tests zum Nachweis und zur Differenzierung von Influenza A, Influenza B und respiratorischem Synzytialvirus in Echtzeit-System Abbott m2000 bekannt
3. IntelligentMDx Receives FDA Clearance for IMDx VanR for Abbott m2000 assay
4. PAREXEL Chief Operating Officer Dr. Mark A. Goldberg Receives Special Recognition Award
5. Leica Biosystems Receives FDA Approval for the Fully Automated Bond Oracle™ HER2 IHC System on the Leica BOND-MAX
6. Nephros Receives 510(k) Clearance for Hemodiafiltration System
7. ProUroCare Medical Receives FDA Clearance for ProUroScan Elasticity Imaging System
8. BONESUPPORT Receives Red Herring 2012 Top 100 Europe Award
9. Diabecline Antibiotic Receives Edison Award for Best New Pharmaceutical Product
10. Lexicon Receives Funding for Phase 2 Clinical Trial of LX4211 in Type 1 Diabetes
11. Alexza Receives Complete Response Letter for Adasuve™ NDA
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/16/2017)... , June 16, 2017  Exactly 50 years ago ... off what later became known as the San Francisco "Summer ... ) is unveiling two radical innovations in strategic market research ... This announcement marks the beginning of Northern Light,s "Summer of ... ...
(Date:6/12/2017)... , June 12, 2017 Kineta, Inc., a biotechnology ... Kineta Vice President of R&D and Head of ... Pandemic Preparedness for the Northwest and Beyond meeting ... on June 14, 2017 from 8:30-10:30 AM PDT at the ... Dr. Bedard will be joined by other ...
(Date:6/8/2017)... MAITLAND, Fla. , June 8, 2017  Less ... ransomware attack that hit more than 200,000 companies, including hospital ... is being heralded as one of the largest online ... technology in the healthcare market, it is imperative that ... can protect their data from this — and many ...
Breaking Medicine Technology:
(Date:6/23/2017)... , ... June 23, 2017 , ... Everybody has their ... while others prefer to read it, and some people don't like it at all. ... Here's what they found: , Erotic literature can give readers a taste of their ...
(Date:6/23/2017)... ... June 23, 2017 , ... 21 Middle East and South Asia Leaders Selected ... from government, business and civil society in 11 countries across the Middle East and ... in a transformative exchange of knowledge and ideas with the leading minds in their ...
(Date:6/23/2017)... ... 23, 2017 , ... Ulster University, Magee Campus in Northern Ireland is hosting ... pm to present to graduate students exciting new and innovative hope research based on ... by The Health Improvement Service of the Western Health & Social Care Trust (WHSCT) ...
(Date:6/23/2017)... ... June 23, 2017 , ... Moore Insurance, ... area with access to asset protection and financial planning services, is teaming up ... improving the lives of children with cancer and other chronic diseases. , The ...
(Date:6/22/2017)... ... June 22, 2017 , ... ... from the American Heart Association (AHA) to launch a Rheumatic Heart Disease Center, ... prevention and diagnosis of rheumatic heart disease (RHD) in high-risk, financially disadvantaged countries ...
Breaking Medicine News(10 mins):