EFTA00675936.pdf

From: Alice Jacobs Nesselrodt :< => To: Alice Jacobs Nesselrodt Subject: IMDx receives 3rd FDA clearance and relocates HQ to Waltham Date: Tue, 12 Nov 2013 21:14:41 +0000 Attachments: IMDx Cdiff Press_Release_12NOV2013.pdf I hope you are doing well and having a great fall. On the heels of a successful move into our new corporate headquarters in Waltham, MA, IMDx today announced its third FDA clearance for its C. difficile assay for Abbott m2000 assay. My best, Alice IntelligentMDx Receives FDA Clearance for IMDx C. difficile for Abbott m2000 Assay, Completes Move of Corporate Headquarters to Waltham WALTHAM, MA, November 12, 2013 -- 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-automatedm2000 system and follows clearances of the IMDx VanR for Abbott m2000 and IMDx Flu A/B and RSV for Abbott m2000 assays. 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 ft:dB-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 EFTA00675936 About IN1Dx 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. Alice Jacobs Nesselrodt, M.D. Chairman & CEO intelligerilMDX 285 Bear Hill Road Waltham. MA 02451 Pho Cell: Fax: Email: Visit us at WE'VE MOVED - Effective October 10, 2013, please send all correspondence and/or shipments to our new Corporate Headquarters located at 285 Bear Hill Road, Waltham, MA 02451. Please note our telephone. fax numbers and email addresses will all remain the same. The information transmitted is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. My review. retransmission, dissemination or other use of, or taking of any action in reliance upon, this information by persons or entities other than the intended recipient is prohibited. If you received this in error, please contact the sender and delete the material from all computers. EFTA00675937