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For Immediate Release
Date: March 25, 2004
Contact: Liz Lloyd, Marketing Communications Manager
Phone: 800.871.8909 ext. 109

TREK Diagnostic Systems is First Diagnostic Manufacturer to Receive FDA Clearance on Daptomycin for Microbroth Dilution Testing Methods

Cleveland, Ohio – March 25, 2004 – TREK Diagnostic Systems is the first company to receive 510K clearance on Daptomycin for microbroth dilution testing methods.
The drug is currently available on TREK Diagnostic Systems’ JustOne® strips (Part No. JODAP).

Manufactured by Cubist, Daptomycin is one of the newest antibiotics. Used once daily, it provides a rapid bactericidal antibiotic effect against MRSA and MSSA. Daptomycin is an antibacterial agent of a new class of antibiotics, the cyclic lipopeptides. It is a natural product which has clinical utility in the treatment of infections caused by aerobic Gram-positive bacteria. The in vitro spectrum of activity of Daptomycin encompasses most clinically relevant Gram-positive pathogenic bacteria. Daptomycin retains potency against antibiotic resistant Gram-positive bacteria, including isolates resistant to methicillin and vancomycin.

“We are proud to announce the availability of Daptomycin with Sensititre susceptibility products. Our dry plate technology allows us to work closely with pharmaceutical companies during the dried plate drug development process,” commented Jenny Lorbach, Global Product Manager for Sensititre. “We worked closely with Cubist in the early stages of Daptomycin development and successfully completed manual and automated read comparative clinical trials. Newer compounds can present manufacturing challenges with some competitive methodologies. The Sensititre manufacturing process is easily adapted to overcome such difficulties. Daptomycin is now available in our JustOne format and will be available for our automated customers in a standard MIC plate format soon.”

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.

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