| |
Press Releases
For Immediate Release
Date: January 8, 2007
Contact: Joan Lamprecht, Associate Product Manager
Phone: 800.871.8909 ext. 243
TREK Receives FDA Clearance for Streptococcus species on Sensititre® Susceptibility
Plates
Cleveland, Ohio — January 8, 2007 – TREK Diagnostic Systems
received FDA clearance for automated and manual reading of MIC susceptibilities for Streptococcus species using both the
Sensititre ARIS 2X® fully automated systems and Sensititre manual platforms.
With this FDA clearance, TREK is the first diagnostic manufacturer of dry microbroth dilution
plates to
offer an in vitro diagnostic use label to test Streptococcal organisms against Daptomycin(Cubicin),
Gemifloxacin (Factive®, Oscient Pharmaceuticals), Ertapenem (Invanz), Telithromycin
(Ketek®, Sanafi-Aventis) and Tigecycline (TYGACIL®, Wyeth) in diagnostic laboratories.
These antimicrobics are available on TREK’s newly designed Streptococcus plate (Part
No. STP5F).
Streptococci isolates can also be tested on TREK’s existing Streptococcus plate (Part
No. STP3F).
“We are pleased to announce the extension of our clearance claims for Streptococcus testing, in light of
the fact that pneumococci and other Streptococci continue to display newly emerging
resistance
patterns,” commented Jenny Lorbach, Director of Global Marketing for TREK Diagnostic
Systems. “We
continue to offer new antimicrobials for in vitro diagnostic test methods faster
than other automated test
methods. Sensititre plates are also unique in that they can be read manually, when
automation is not
available in a diagnostic laboratory.”
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.
About TREK Diagnostic Systems
TREK Diagnostic Systems, a subsidiary of Magellan Biosciences, Inc., is a global manufacturer and
distributor of automated systems and consumable products for microbiology diagnostic
testing serving the clinical, pharmaceutical, and veterinary laboratory markets. Signature product lines,
the VersaTREK® Automated Microbial Detection System and the fully automated Sensititre® ARIS 2X® System,
are designed to provide cost effective improvements in workflow efficiencies, ergonomics,
and test result performance. For more information, visit www.trekds.com.
About Magellan Biosciences
Magellan serves the worldwide clinical-diagnostics market with rapid point-of-care
analyzers and automated systems for hospital-based labs and near-patient testing. Scientists use
the company’s discovery systems and sensors for cutting-edge research to develop a new understanding
of health and illness – from disease pathology to biomarker identification. Magellan designs all
its systems, sensors, and consumables to deliver better, more-reliable results. And better results help
drive improved health outcomes: earlier, more-accurate diagnoses; breakthroughs that can lead to novel
treatments, new cures – innovations to enhance life. A privately held company, Magellan serves customers
through wholly owned subsidiaries: TREK Diagnostic Systems, ESA Biosciences, Dynex Technologies,
and TekCel. For more information, visit www.magellanbio.com.
For more information, contact Joan Lamprecht at 1.800.871.8909 ext. 243 or via e-mail
at
jlamprecht@trekds.com.
###
< back
|
 |