From: Alice Jacobs <I To: Denise Marston <I CC: Denise Marston <I Subject: MDx Receives FDA Clearance for IMDx VanR for Abbott m2000 assay Date: Tue, 30 Jul 2013 14:40:22 +0000 Attachments: IMDx VanR for Abbott m2000 FDA clearance_.pdf I hope you are doing well and are having a great summer. I am pleased to announce that IMDx has achieved a pivotal milestone with the receipt of FDA clearance for its Vancomycin Resistance (VanR) test for the Abbott m2000 system. This test detects vancomycin-resistance genes that can be associated with vancomycin resistant enterococci (VRE.) 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. My best, Alice IntelligentMDx Receives FDA Clearance for IMDx VanR for Abbott m2000 assay Cambridge, MA, July 29, 2013 — 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, rect