FDA Clears Caspofungin Susceptibility Testing for TREK Diagnostic Systems' Sensititre(R) YeastOne(R) in Vitro Diagnostics (IVD) Product Line
Published: Jul 08, 2009
CLEVELAND, July 7 /PRNewswire/ -- TREK Diagnostic Systems, a Magellan Biosciences business and premier provider of diagnostic systems and susceptibility products for microbiology labs, has received clearance from the U.S. Food and Drug Administration (FDA) to include caspofungin in its line of YeastOne susceptibility products. TREK will make the drug available on custom YeastOne formats, allowing clinicians to create the plate that best meets their requirements. The custom format complements TREK's standard IVD-cleared YeastOne product (Part No. YO-2V), which contains the four most widely-prescribed antifungals: itraconazole, fluconazole, 5 flucytosine and voriconazole.
Physicians typically prescribe intravenous caspofungin therapy when other treatment regimes are not well tolerated or have failed. The first in a new class of enzyme-inhibiting antifungal agents, caspofungin, is FDA-cleared for treatment of candidiasis in adults and pediatric patients. Candidiasis is a fungal infection that can be life-threatening if it becomes systemic.
"This is the second FDA clearance we have received this year for our YeastOne product line," said President of Magellan's diagnostics business, James Whelan. "Last month, we announced the addition of voriconazole to our standard YeastOne IVD plate. Our goal with IVD susceptibility products is to increase reportable compounds and treatment options for clinicians. Customers need plates that allow them to report timely results using a fully reimbursable format. We are committed to taking our products through the FDA clearance process where feasible and appropriate. Because pharmaceutical companies use our Sensititre susceptibility system during drug development, we often get early access to the latest therapeutics and are able to provide clinicians with the widest possible drug choices. A wide array of cost-effective plate formats that deliver timely and reliable results not only supports pharmacy cost-control efforts - it improves patient care."
About the Sensititre YeastOne Product Line
TREK offers a wide range of FDA cleared and research-use-only (RUO) YeastOne dried microbroth dilution plates with a variety of drug options. The products provide physicians and researchers with fast, cost-effective, and reliable results. Plates feature standard 24-hour incubation, easy-to-read colorimetric endpoints, and on-scale QC ranges, making antifungal susceptibility testing a viable in-house procedure for virtually any size laboratory.
* YeastOne for IVD -- The YeastOne product line received its first FDA clearance in 2001 and has been widely recognized for accuracy. TREK's standard IVD YeastOne plate (Part No. YO-2V) is the only IVD-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.
* YeastOne for RUO -- TREK's standard RUO YeastOne plate (Part No. YO-9*) includes nine antimicrobics: anidulafungin, amphotericin B, caspofungin, fluconazole, 5 flucytosine, itraconazole, micafungin, posaconazole and voriconazole.
*For research use only. Not for use in diagnostic procedures.
* Custom YeastOne plates -- Labs can customize plates by selecting from nine antifungal agents, including five cleared antifungal compounds, and specifying format and drug concentrations to create the best plate for their particular needs. Small minimum order quantities allow for better cost and inventory control. To learn more about custom plates, call customer service toll-free at 800 871-8909. Outside the US and Canada, dial +44 (0) 1342-318777 or e-mail: firstname.lastname@example.org
About TREK Diagnostic Systems (www.trekds.com)
A Magellan Biosciences diagnostics business, 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®, Sensititre®, Vizion®, 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.
Cancidas is a registered trademark of Merck & Co., Inc.