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MicroPhage recently announced that it 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. 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. MicroPhage began commercial sales in the US through Cardinal Health in December of 2011.
www.microphage.com
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