The US Food and Drug Administration (FDA) has granted an additional 510(k) clearance to MicroPhage's KeyPath MRSA/MSSA blood culture test-BT.
The KeyPath MRSA/MSSA blood culture test-BT is designed to diagnose and distinguish methicillin resistant Staphylococcus aureus (MRSA) and methicillin sensitive Staphylococcus aureus (MSSA) in positive blood cultures.
The additional approval allows the test to 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 said it 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 in 2012.
MicroPhage president and CEO Don Mooney said clearances for use with both major blood culture systems ensure more than 90% of US hospitals have access to the antibiotic susceptibility results provided by KeyPath.
"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," Mooney added.