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 IMDx™ C. difficile assay
for the Abbott m2000™ 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 competitiv
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