Additional FDA Clearing for KeyPath™ MRSA/MSSA Blood Culture Test
MicroPhage has received an additional FDA 510(k) clearance that significantly expands the market for its KeyPath™ MRSA/MSSA Blood Culture Test-BT.
The KeyPath™ MRSA/MSSA Blood Culture Test-BT test is the first and only blood test to quickly diagnose and distinguish methicillin resistant and methicillin sensitive Staphylococcus aureus (MRSA vs. MSSA) in positive blood cultures. The test is now cleared for use with four BD BACTEC™ blood culture bottle types including the BD BACTEC™ Plus Aerobic/F, Plus Anaerobic/F, Standard/10 Aerobic/F and Standard/10 Anaerobic/F blood culture bottles.
MicroPhage is now entering clinical trials to further expand clearances to use of bioMerieux BacT/ALERT® blood culture bottles and will seek 510(k) clearance later this year. 'Clearances for use with both major blood culture systems ensure more than 90% of US hospitals have access to the accelerated antibiotic susceptibility results KeyPath™ provides,' said Don Mooney, MicroPhage President and CEO. 'MicroPhage will continue to expand its KeyPath™ platform and utilize its susceptibility differentiation to address skin and soft tissue infections and infections caused by Gram negative bacteria.'
The KeyPath™ MRSA/MSSA Blood Culture Test-BT received initial FDA 510(k) market clearance in May of 2011 for the identification of S. aureus and differentiation of MRSA from MSSA in positive blood cultures. It is the first and only test in a new test category for accelerated antibiotic susceptibility. KeyPath™ delivers results two days earlier than traditional methods thus providing physicians a significant time advantage in treating critically ill patients with bloodstream infections.
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Source : Microphage, Inc. View archived contact details
Posted on April 17, 2012