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Press Releases
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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