Navigation Links
IntelligentMDx Receives FDA Clearance for IMDx VanR for Abbott m2000 assay
Date:7/29/2013

CAMBRIDGE, Mass., July 29, 2013 /PRNewswire/ -- IntelligentMDx (privately held) announced today that the U.S. Food and Drug Administration (FDA) has cleared its automated molecular diagnostic test that detects the presence of vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE). This is one of the tests in IMDx's portfolio of infectious disease products to be cleared by the FDA for use on Abbott's fully automated m2000 platform.

VRE are bacteria which have become resistant to the antibiotic vancomycin, and are responsible for a variety of healthcare-associated infections, including surgical wound, urinary tract, and bloodstream infections. The IMDx VanR for Abbott m2000 assay is intended to be used as an aid to identify, prevent and control vancomycin-resistant colonization in healthcare settings.

The automated nature of the IMDx VanR for Abbott m2000 test allows laboratories to obtain results for up to 46 patient samples in less than 3 hours, and up to 94 patient samples in less than 4 hours. The assay is performed directly on human peri-rectal swabs, rectal swabs, or stool specimens from patients at risk for VRE colonization.

"We are proud to have received FDA clearance so that IMDx can offer a diagnostic solution to aid in the identification of vancomycin-resistant colonization in hospital settings in the U.S.," says Dr. Alice Jacobs Nesselrodt, Chairman and CEO of IMDx. "FDA clearance of the IMDx VanR for Abbott m2000 assay is a step toward the fulfillment of IMDx's mission to make clinically impactful molecular diagnostic testing solutions available as broadly as possible. We look forward to continuing to expand our menu of diagnostic tests in the U.S."

The IMDx VanR 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.

About IMDx

Based in Cambridge, MA, IMDx (www.IntelligentMDx.com) is an innovator of unique proprietary molecular tests equipped with features and benefits to port onto nearly any molecular testing system. IMDx's competitive advantage lies in its extensive bioinformatics capabilities, enabling the production of rapid, low cost high quality products with top performance characteristics to empower clinicians to provide care with greater certainty. Current and future product lines include tests for Infectious Diseases (Healthcare Associated Infections, respiratory diseases, STDs, prenatal testing), oncology and other human genetic targets. The IMDx facilities are ISO 13485:2003 certified and all of the IMDx products are developed and manufactured within a regulatory compliant (FDA QSR, CE-IVDD and cGMP) environment.

CONTACT: Renda Hawwa, +1-617-871-6417, cc@intelligentmdx.com


'/>"/>
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. PAREXEL Chief Operating Officer Dr. Mark A. Goldberg Receives Special Recognition Award
4. Leica Biosystems Receives FDA Approval for the Fully Automated Bond Oracle™ HER2 IHC System on the Leica BOND-MAX
5. Nephros Receives 510(k) Clearance for Hemodiafiltration System
6. ProUroCare Medical Receives FDA Clearance for ProUroScan Elasticity Imaging System
7. BONESUPPORT Receives Red Herring 2012 Top 100 Europe Award
8. Diabecline Antibiotic Receives Edison Award for Best New Pharmaceutical Product
9. Lexicon Receives Funding for Phase 2 Clinical Trial of LX4211 in Type 1 Diabetes
10. Alexza Receives Complete Response Letter for Adasuve™ NDA
11. Ventana Receives FDA Clearance for p53 (DO-7) Image Analysis and Digital Read Applications
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... Dehaier Medical Systems Ltd. (NASDAQ: DHRM ) ... medical devices and wearable sleep respiratory products in ... with Hongyuan Supply Chain Management Co., Ltd. (hereinafter referred ... to develop Dehaier,s new Internet medical technology business. ... Hongyuan Supply Chain,s sales platform to reach Dehaier,s dealers ...
(Date:6/24/2016)... , June 24, 2016 ... appointment of Dr. Edward Futcher to ... Director, effective June 23, 2016.Dr. Futcher was also ... and Governance Committees.  As a non-executive member of ... expertise and strategic counsel to VolitionRx in connection ...
(Date:6/23/2016)... , June 23, 2016 Research ... "Pharmaceutical Excipients Market by Type (Organic Chemical (Sugar, Petrochemical, ... (Oral, Topical, Coating, Parenteral) - Global Forecast to 2021" ... The global pharmaceutical excipients market is ... a CAGR of 6.1% in the forecast period 2016 ...
Breaking Medicine Technology:
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... PawPaws ... a new product that was developed to enhance the health of felines. The formula ... , The two main herbs in the PawPaws Cat Kidney Support Supplement ...
(Date:6/25/2016)... ... 25, 2016 , ... The temporary closing of Bruton Memorial Library on June 21 due to ... a new, often overlooked aspect of head lice: the parasite’s ability to live away from ... common occurrence, but a necessary one in the event that lice have simply gotten out ...
(Date:6/25/2016)... ... ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department of Health ... of their exemplary accomplishments in worksite health promotion. , The Wellness at Work Awards ... at the BWI Marriott in Linthicum Heights. iHire was one of 42 businesses to ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was ... his family verbally and physically. , “When something upset him, he couldn’t control his emotions,” ... He would throw rocks at my other children and say he was going to kill ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and ... that call for a minimum wage raise to $12 an hour by 2020 and then ... will restore the lost value of the minimum wage, assure the wage floor does not ...
Breaking Medicine News(10 mins):