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FDA Clears Magellan Biosciences Sensititre MIC Plates

Magellan Biosciences, a provider of clinical diagnostics products, has started offering minocycline and telavancin on IVD-labeled microbroth dilution susceptibility plates.

The TREK-brand Sensititre MIC plates have received FDA clearance for testing minocycline against gram positive and gram negative bacterial isolates, as well as telavancin against gram positive bacterial isolates and fastidious Streptococcus species isolates.

The FDA has also broadened the tigecycline clearance on the Sensititre platform to include Streptococcus pneumoniae testing.

Magellan said that 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 soon. Tigecycline is available on Sensititre Streptococcus spp. MIC plate, as well as on custom formats.

Minocycline 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.

Magellan Biosciences also said that 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.

Hiroshi Uchida, president and chief executive officer of Magellan, said: “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.

“The 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.”