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

bs 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


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