EFTA00687759.pdf

From: "Alice Jacobs" To: "Denise Marston" Subject: IMDx Introduces CE-marked Assay for C. difficile for European Market Date: Tue, 02 Aug 2011 23:45:37 +0000 I wanted to update you with our latest news. I hope that you're doing well. My best, Alice Intelligent Medical Devices, Inc. (IMDx) Introduces a CE-Marked Automated Assay for the Detection of C. difficile Including Hypervirulent Strains CAMBRIDGE, Mass., Aug. 1, 2011 /PRNewswire/ -- Intelligent Medical Devices, Inc. (IMDx) today announced it has received CE-Mark for a high-throughput automated assay for the detection of C. difficile, including the A-B+ 1470 variant, as well as the NAP1 strain. The IMDxTM C. difficile assay for the Abbott m2000TM is the first assay released under a multi-year distribution agreement between Abbott and IMDx whereby IMDx will design, develop, regulatory clear, and manufacture assays for the Abbott FDA cleared m2000 instrument. Designed utilizing IMDx's proprietary bioinformatics process, the IMDx C. difficile assay for the Abbott m2000 demonstrates a sensitivity of 95.7 percent and a specificity of 100 percent (internal comparison data). C. difficile may develop after prolonged antibiotic use and is the most frequent cause of health- care-associated diarrhea, also causing more severe intestinal conditions such as colitis. The bacterium is easily transmitted via direct contact with high-touch surfaces in patient rooms, contaminated patient-care items, and hands of health-care workers. "Our assays are developed to incorporate evolving clinical needs. Not only do we offer automated detection of toxigenic C. difficile genes, shortening the time needed to diagnose infections, but we also cover the detection of hypervirulent strains, including NAP1, and tcdB-variant strains, including 1470. Early identification of pathogens is critical in improving patient healthcare, shortening hospital stays, and reducing expenses," says Alice Jacobs, MD, Chairman & CEO of IMDx. About IMDx Based in Cambridge, MA, IMDx (www.IntelligentMDx.com) is an innovative company that designs, develops and manufactures molecular diagnostic products. IMDx has developed molecular solutions that are clinically impactful and competitively differentiated for a range of disease areas for current and next generation systems, including targets in infectious diseases, oncology and genetics. IMDx's expertise spans evolutionary biology, bioinformatics, microbiology, chemistry and molecular biology. These capabilities are harnessed by IMDx's proprietary bioinformatics and product development processes allowing for the rapid design and development of tests to meet clinical needs. CONTACT: Renda Hawwa, SOURCE Intelligent Medical Devices, Inc. (IMDx) Alice A. Jacobs, M.D. Chairman 84 CEO IntelligentMOx EFTA00687759 19 Blackstone Street Cana Phone: Cell: Fax: Email: Visit us at www.inte Gent x.com 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. EFTA00687760