Press Releases

For Immediate Release
Date: August 27, 2004
Contact: Liz Lloyd, Marketing Communications Manager
Phone: 800.871.8909 ext. 109

TREK Diagnostic Systems Receives FDA Clearance on Telithromycin (Ketek™)

Cleveland, Ohio – August 27, 2004 – TREK Diagnostic Systems recently received 510K clearance on Telithromycin 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 Telithromycin in diagnostic laboratories. TREK received clearance to test and report Telithromycin against the following bacterial groups using Sensititre MIC susceptibility methods: Staphylococcus species, Streptococcus pneumoniae, Streptococcus species and Haemophilus influenzae. Telithromycin belongs to the ketolide class of antibacterials and is structurally related to the macrolide family of antibiotics.

Telithromycin is currently available for inclusion on custom plates or can be tested on JustOne® for Telithromycin (Part No. JOTEL). Sensititre MIC Plates for Streptococcus pneumoniae and Gram-positive isolates containing Telithromycin will be available in Fall 2004.

“We are proud to announce the availability of Telithromycin on Sensititre plates for in vitro diagnostic susceptibility methods,” commented Jenny Lorbach, Global Product Manager for Sensititre, “Our dry plate technology allows us to work closely with pharmaceutical companies during the dried plate drug development process. Telithromycin 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®, ESP®, 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.