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Press Releases
For Immediate Release
Date: October 6, 2005
Contact: Liz Lloyd, Marketing Communications Manager
Phone: 800.871.8909 ext. 109
TREK Diagnostic Systems Receives FDA Clearance on Tigecycline (Tygacil™)
Cleveland, Ohio – October 6 , 2005 –TREK Diagnostic Systems recently received 510(k) clearance on Tigecycline for Sensititre® MIC susceptibility plates.
TREK Diagnostic Systems is the first susceptibility test manufacturer of dry microbroth dilution plates to offer an in vitro diagnostic use label to test Tigecycline in diagnostic laboratories. TREK received clearance to test and report Tigecycline against the following bacterial groups using Sensititre MIC susceptibility methods: aerobic facultative Gram-positive and aerobic facultative Gram-negative microorganisms. Tigecycline is the first glycylcycline and was designed to circumvent key bacterial resistant mechanisms.
Tigecycline is currently available for inclusion on custom plates or can be tested on JustOne® for Tigecycline (Part No. JO-TGC). Gram-negative and Gram-positive MIC plates will contain Tigecycline later this year.
“We are proud to announce the availability of Tigecycline on Sensititre plates for in vitro diagnostic susceptibility methods,” commented Jenny Lorbach, Global Product Manager for Sensititre. “The immediate availability of Tigecycline for Sensititre MIC test procedures emphasizes our success with early FDA clearance on new compounds versus other test systems. Tigecycline is now available in our JustOne format and will soon be available for our automated customers in standard MIC plate formats.”
TREK’s Sensititre® product line combines a history of development and manufacturing expertise with a cost effective and flexible approach to customized susceptibility and identification testing. TREK Diagnostic Systems offers a full range of services for clinical trial management worldwide including custom susceptibility plate design, MIC testing for new drug clearance, resistance surveillance testing, antifungal testing, and frozen NCCLS reference panel manufacturing. TREK provides full diagnostic support for laboratories in the United States and in Europe.
Founded in January 1999, TREK Diagnostic Systems is a global manufacturer and distributor of automated systems and consumable products for the microbiology diagnostic laboratory. Signature product lines include VersaTREK®, Sensititre®, alamarBlue®, para-JEM®, YeastOne®, onSite®, and TREK Lab Services. TREK is committed to delivering the highest quality products and services to clinical, pharmaceutical, and veterinary diagnostic laboratories worldwide.
For more information, contact Liz Lloyd at 216.485.1140 or via e-mail at elloyd@trekds.com
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