MicroPhage has gained an additional FDA 510 clearance for its KeyPath MRSA/MSSA Blood Culture Test-BT.
Blood test was initially cleared to 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 president and CEO Don Mooney said that the 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.
"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.