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FDA Clears Three Additional Antimicrobials for Use on TREK Sensititre(R) In Vitro Diagnostic (IVD) MIC Susceptibility Plates: Minocycline and Telavancin Used to Treat MRSA and Other Infections; and Tigecycline, Now Cleared for Streptococcus Pneumoni
Date:3/23/2010

CLEVELAND, March 23 /PRNewswire/ -- Magellan Biosciences, Inc., an emerging leader in clinical diagnostics products, announced that the company has become the first to offer minocycline and telavancin on IVD-labeled microbroth dilution susceptibility plates. The U.S. Food and Drug Administration (FDA) has cleared TREK-brand Sensititre MIC plates for testing minocycline against Gram positive and Gram negative bacterial isolates, as well as telavancin against Gram positive bacterial isolates and fastidious Streptococcus sp. isolates. The FDA has also broadened the tigecycline clearance on the Sensititre platform to include Streptococcus pneumoniae testing.

"Easy, cost-effective susceptibility testing is key in the global effort to prevent MRSA (methicillin-resistant Staphylococcus aureus) and other drug-resistant infections, and we are committed to growing our susceptibility product line with new reportable compounds that expand treatment options for clinicians," said Magellan President and Chief Executive Officer Hiroshi Uchida, Ph.D. "These new clearances demonstrate that Magellan continues to deliver on our successful development strategy – bringing products to market that make diagnostic testing easier, more cost-effective and less labor-intensive."

Minocycline and telavancin are available for immediate use on Sensititre custom IVD formats and the company plans to add the drugs to several of its standard IVD-labeled plates in the coming months. Tigecycline is available now on Sensititre Streptococcus spp. MIC plate, as well as on custom formats.

Minocycline, sold under a variety of trade names, is a generic, oral, broad-spectrum tetracycline antibiotic, known for having broader activity than other members of the tetracycline class. Doctors prescribe the drug to treat skin, respiratory, and urinary tract infections, as well as MRSA and drug-resistant Acinetobacter spp. isolates. Telavancin is a new intravenous lipoglycopeptide antibiotic sold under the trade name Vibativ®, used in the treatment of complicated skin and skin-structure infections (cSSSI) due to Gram-positive pathogens, including MRSA. Tigecycline, a glycylcycline antibiotic, is sold under the brand TYGACIL®.

Commenting on Magellan's strong track record with the FDA, Dr. Uchida said, "Over the past two years, we have extended our portfolio of FDA-cleared products, introducing a number of new IVD plates, including a Gram-positive plate used in MRSA detection, which is FDA-cleared for D-Test and Cefoxitin screening, and YeastOne® plates available with five IVD-cleared antifungal compounds: itraconazole, fluconazole, 5-flucytosine, voriconazole, and caspofungin. To meet expanding customer needs, we also continue to offer new plates for research use only (RUO)."

About the Sensititre Product Line

Magellan's TREK-brand Sensititre product line for susceptibility and identification testing enables labs to 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. This saves microbiology labs from having to use multiple off-line test procedures to obtain accurate susceptibility data. Magellan often gets early access to the latest therapeutics because pharmaceutical companies use the Sensititre system during drug development. The platform is also the system-of-choice for global surveillance initiatives, including NARMS (National Antimicrobial Resistance Monitoring System). We offer a full range of standard and custom Sensititre plates featuring 18- to 24-hour incubation, true MIC endpoints, and on-scale QC ranges, making susceptibility testing a viable procedure for laboratories of virtually any size. For custom dried or reference-method plates, laboratories can specify format and antimicrobic concentrations, selecting from more than 240 agents, including 80+ cleared compounds, to create a plate best-suited for the lab's particular need. Small minimum order quantities allow for better cost and inventory control.

Better Dx = Better Rx – About Magellan (www.magellanbio.com)

Founded in 2004, Magellan's innovative technologies make diagnostic testing easier, more cost-effective, and less labor intensive. The company's products deliver the timely information that clinicians need to make appropriate treatment decisions and improve outcomes for patients. They include LeadCare®-brand rapid point-of-care systems to screen children and adults for lead poisoning; TREK-brand microbiology products for blood culture and susceptibility testing that help in the global effort to prevent MRSA and other drug-resistant infections; as well as Dynex® -brand automated ELISA processing systems for a wide variety of immunoassays – from infectious disease to autoimmune and food-safety testing. Magellan has approximately 290 employees worldwide.

SOURCE Magellan Biosciences, Inc.

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SOURCE Magellan Biosciences, Inc.
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