Navigation Links
IntelligentMDx Receives FDA Clearance for IMDx VanR for Abbott m2000 assay

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 ( 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,

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:
(Date:11/30/2015)... Texas , Nov. 30, 2015  Hanger, Inc. ... amendment and restatement of the terms of its previously ... Solicitation") relating to its $200,000,000 aggregate principal amount 7⅛% ... other things, (i) the consent fees payable pursuant to ... on the Notes and (iii) the expiration date of ...
(Date:11/30/2015)... NAMUR , Belgium , Nov. 30, ... life sciences company focused on developing blood-based diagnostic tests for ... announced the Company will present at the LD Micro Conference, ... Los Angeles, CA. Attending from VolitionRx will ... and Scott Powell , Vice President of Investor Relations. ...
(Date:11/30/2015)... , November 30, 2015 PFE ... at up to 10 G protein-coupled receptor (GPCR) targets ... to research and develop potential new medicines directed at ... multiple therapeutic areas. --> Heptares Therapeutics ("Heptares"), ... and wholly-owned subsidiary of Sosei Group Corporation ("Sosei"; TSE ...
Breaking Medicine Technology:
(Date:11/30/2015)... , ... November 30, 2015 , ... RoamRight, a leading ... with Public Television’s Travel With Kids to promote family vacations around ... family as they explore international destinations and educate families about the people and places ...
(Date:11/30/2015)... ... November 30, 2015 , ... Advocare Orthopedic ... orthopedic care. Led by John Vitolo, M.D., the center offers their patients ... team at Advocare Orthopedic & Sports Medicine is ready to help their patients ...
(Date:11/30/2015)... ... November 30, 2015 , ... International telepathology consultations ... and KingMed Diagnostics researchers. Their review of more than 1,500 ... UPMC pathologists resulted in significantly altered treatment plans for more than half of ...
(Date:11/30/2015)... ... November 30, 2015 , ... The American Society for Clinical Pathology (ASCP) announced ... Day 2015. On Nov. 30, ASCP shared its “Give a minute. Get tested. Find ... and the importance of getting tested for HIV. , ASCP has asked members to ...
(Date:11/30/2015)... ... ... An inventor from Charlottesville, Va., is concerned about the need for peace and ... due to loud noises," she said, "so I decided that there needs to be ... radio waves and microwaves." , The baby BABY MUFF prevents loud noises, radio waves ...
Breaking Medicine News(10 mins):