Magellan Biosciences Inc announces that the company has become the first to offer minocycline and telavancin on IVD-labeled microbroth dilution susceptibility plates.
The 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, PhD "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)."
Source: Magellan Biosciences