Susceptibility Plates serve in-vitro diagnostics, research.
Press Release Summary:
Designed for in-vitro diagnostics, YeastOne susceptibility plate is FDA-cleared for testing Candida species isolates against 4 antifungal agents: voriconazole, fluconazole, 5-flucytosine, and itraconazole. It features 24 hr incubation, colorimetric endpoints, and on-scale QC ranges. Available for research use, Sensititre® Xtra Gram Negative MIC plate incorporates 21 antimicrobic compounds. These include doripenem, colistin, polymixin B, doxycycline, minocycline, ertapenem, and imipenem.
Original Press Release:
TREK to Introduce New In Vitro Diagnostic and Research-Use-Only Susceptibility Products at American Society for Microbiology General Meeting, Booth 1301
- Company receives clearance to add voriconazole to its YeastOne(R) susceptibility plate for in vitro diagnostics; plate now includes four FDA-cleared antifungal agents
- New Research-Use-Only Sensititre(R) Xtra Gram Negative MIC Plate incorporates 21 antimicrobics, including colistin and polymixin B
CLEVELAND, May 14 -- TREK Diagnostic Systems, a Magellan Biosciences company and premier provider of diagnostic systems and susceptibility products for microbiology labs, will introduce two new susceptibility plates next week at the American Society for Microbiology (ASM) general meeting. TREK's YeastOne susceptibility plate for in vitro diagnostics and research-use-only Sensititre Xtra Gram Negative MIC plate both build on the company's leading platform of Sensititre susceptibility products, which are used widely by physicians and researchers as they work to address the serious and growing problem of drug-resistant infections, and by pharmaceutical companies in their new drug development.
"Susceptibility testing is a critical tool in combating drug resistance," explained James Whelan, president of Magellan's Clinical Diagnostics business. "It is now well known that the widespread and inappropriate use of antibiotics contributes to the creation of 'superbugs' that have become immune to many existing drugs. There has also been a documented increase in recent years of drug-resistant fungal infections, particularly in severely immuno-compromised and/or critically ill patients. The latter is the target of our new YeastOne dried microbroth dilution plate (Part No. YO-2V), which increases reportable compounds and treatment options for clinicians."
Mr. Whelan continued, "Increasingly, clinicians and researchers are relying on combinations of drugs. At TREK, we provide microbiology labs with both the latest FDA-cleared drugs and the widest range of formulations in a platform that improves test methods and reduces costs. The goal of our IVD susceptibility products is to help physicians safely and effectively fight infection without contributing to drug resistance by ensuring that they prescribe the right drug treatment or drug combination to stop microbial growth. YeastOne is the first in vitro diagnostic-labeled susceptibility product that is FDA-cleared for testing Candida species isolates against four commonly prescribed FDA-cleared antifungal agents: voriconazole, fluconazole, 5-flucytosine, and itraconazole. The plate features standard 24-hour incubation, easy-to-read colorimetric endpoints, and on-scale QC ranges, making antifungal susceptibility testing a viable in-house procedure for any size laboratory."
Turning to the company's new Sensititre Xtra Gram Negative MIC Plate (Part No. GNXF), Mr. Whelan said, "Our research-use-only plates help scientists better understand drug resistance. We designed this new Gram negative plate to include the antimicrobics colistin and polymixin B at the request of drug-resistance researchers because of resurgence in the use of these 50-year-old antibiotics to treat multi-drug-resistant infections. The plate incorporates 21 antimicrobic compounds, including doripenem, colistin, polymixin B, doxycycline, minocycline, ertapenem, and imipenem. In the U.S. and Canada, the plate is available for research-use-only, not for use in diagnostic procedures; minocycline, colistin and polymixin B have not been FDA-cleared for IVD use with FDA-approved interpretive criteria. Plates can be read manually and with TREK's Vizion(R) system, or read using the automated ARIS 2X System."
ARIS is part of the company's line of Sensititre Automated Susceptibility and Identification Testing products, designed so labs can test -- on a single cost-effective, LIS-compatible system -- more FDA-cleared antimicrobial drugs than on any other automated platform against the widest range of non-fastidious and fastidious bacteria and yeasts. Sensititre takes the guesswork out of reading susceptibility results and eliminates the need for microbiology labs to use multiple off-line test procedures to obtain accurate susceptibility data. Since Sensititre is the susceptibility platform that pharmaceutical companies use in their drug-development process, TREK has early access to the latest antimicrobial therapies. Sensititre is also the system-of-choice for global surveillance programs, including NARMS (National Antimicrobial Resistance Monitoring System).
The company will also feature at ASM its FDA-cleared Vizion System, which integrates with a lab's information system to eliminate transcription errors. It also adds easy-to-read digital imaging capability, enabling users to share or store images for future reference, training, and decision-making processes. TREK's award-winning VersaTREK(R) Automated Microbial Detection System will also be on view. VersaTREK is the only system that performs four tests on one automated platform: culture for blood, sterile body fluids, and mycobacteria, as well as Mycobacterium tuberculosis (TB) susceptibility testing.
The 109th annual ASM General Meeting will be held May 17-21, 2009, at the Pennsylvania Convention Center in Philadelphia. TREK will exhibit in Booth 1301. TREK will also present a number of poster presentations at the ASM meeting, including the following:
Monday, May 18, 2009 A Multi-Site Study Comparing an 18-24h
10:45 am to 12:15 pm Sensititre(R) Susceptibility System to the
Presentation: C-015 CLSI Broth Microdilution Method for Oritavancin
Poster #: 133 Using Fastidious and non-Fastidious Gram-positive
Organisms
Monday, May 18, 2009 A Multi-Site Study of the Sensititre(R)
10:45 am to 12:15 pm Susceptibility System Compared with the CLSI
Presentation: C-012 Microdilution Method for MIC Determination of
Poster #: 136 Gram-Negative and Gram-Positive Organisms vs.
Ceftaroline
Monday, May 18, 2009 An Equivalency Study of the Sensititre(R) Dried
10:45 am to 12:15 pm MIC System Compared with the CLSI Broth
Presentation: C-011 Microdilution Reference Method for TR-700 and
Poster #: 110 Comparator Antimicrobials
Monday, May 18, 2009 A Retrospective Examination of Mycobacteria
10:45 am to 12:15 pm Recovery Rates from the VersaTREK Automated
Presentation: C-022 Microbial Detection System and the MGIT(R)960
Poster #: 143
Monday, May 18, 2009 Resins Do not Adsorb All Antibiotics at Peak
1 to 2:30 pm Serum Concentrations, Especially the Newer Beta-
Presentation: C-048 Lactam Antibiotics
Poster #: 290
About TREK Diagnostic Systems (www.trekds.com)
A Magellan Biosciences diagnostics company, TREK is a global manufacturer and distributor of automated systems and consumable products for microbiology-based diagnostic testing designed to improve patient outcomes. Signature product lines include VersaTREK(R), Sensititre(R), Vizion(R), alamarBlue(R), para-JEM(R), YeastOne(R), onSite(R), and TREK Lab Services. TREK is committed to delivering the highest quality products and services to clinical, pharmaceutical, and veterinary diagnostic laboratories worldwide.
CONTACT: Caroline Grossman for TREK Diagnostic Systems, +1-781-771-5579, cgrossman@magellanbio.com; or Carlene Simmons of TREK Diagnostic Systems, +1-800-871-8909 ext. 109, csimmons@trekds.com
