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Press Releases
For Immediate Release
Date: February 29, 2008
Contact: Carlene Simmons, Marketing Communications Manager
Phone: 800.871.8909 ext. 109
FDA Clears Doripenem for TREK Sensititre® In Vitro Dry
Microbroth Plates used in Clinical-Diagnostic Laboratories
Cleveland, Ohio — Februrary 29, 2008 – TREK Diagnostic Systems, a
Magellan Biosciences company and leading provider of susceptibility products for microbiology
labs, is the first diagnostic manufacturer of dry microbroth dilution plates to offer an in
vitro diagnostic-labeled product to test Doripenem (DORIBAX™) in diagnostic laboratories.
TREK products now have clearance to test and report Doripenem against Gram negative
bacilli using Sensititre MIC susceptibility methods, enabling laboratories to report
additional antimicrobic results and providing a wider range of treatment options for clinicians.
“We are pleased to announce the extension of our clearance claims
for Doripenem, which was previously available to our customers for research
use only,” commented the Director of Global Marketing for TREK Diagnostic
Systems, Jenny Lorbach. “Diagnostic labs can now test and report the
broadest range of antimicrobials using the Sensititre platform. We continue
to offer new antimicrobials for in vitro diagnostic test methods earlier
than manufacturers of other automated test methods – a key part of our
commitment to help our laboratory customers deliver better results to improve
health outcomes for patients.”
Doripenem was cleared by the FDA on October 12, 2007, for the treatment
of complicated intra-abdominal infections and complicated urinary tract infections.
It belongs to the carbapenem class of antibacterial agents, which are useful
in treating infections caused by Gram positive and Gram negative bacteria.
Doripenem is manufactured in the U.S. by Johnson & Johnson Pharmaceutical
Research and Development, L.L.C., and marketed under the name DORIBAX.
With a long history of developing and manufacturing cost-effective customized
susceptibility and identification plates, 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 CLSI reference plate
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. TREK is a wholly owned subsidiary of Magellan Biosciences.
For more information, contact Carlene Simmons at 1.800.871.8909 ext. 109 or via e-mail
at csimmons@trekds.com.
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