MicroPhage, a developer of in-vitro diagnostic test products, has submitted human data from a pivotal clinical study of its ‘Microphage MRSA/MSSA Blood Culture Test’ to support FDA 510(k) premarket notification process.
The MicroPhage’s instrument-free, rapid tests are based on its patented Bacteriophage Amplification platform technology. The company has also begun OUS commercial shipments of the test.
MicroPhage’s initial commercial product ‘Microphage MRSA/MSSA Blood Culture Test’ which has previously received regulatory clearance (CE Mark) to be sold in Europe and has been designed to identify Staphylococcus aureus (staph) bacteria as well as determine methicillin resistance (MRSA) or susceptibility (MSSA) in suspected cases of bacteria in the blood in as little as five hours.
MicroPhage has said that the MicroPhage MRSA/MSSA Blood Culture Test requires no instrumentation and begins with two small reaction tubes for incubating blood culture specimens. After only five hours, the incubated samples will be added to a dual dipstick-like detector, which looks much like a home pregnancy test.
One part of the test will identify if the blood sample is infected with S. aureus bacteria and the other shows whether it is susceptible or resistant to methicillin-type antibiotics. Delivering this diagnostic information quickly will enable physicians to determine more effective and precise antibiotics that could shorten hospital stays, lower health care costs and, ultimately, save lives. S. aureus bacteria typically has a mortality rate of >20%.
The company has adapted Bacteriophage Amplification, a natural biologic process, for identifying bacterial infections.
Steve Lundy, CEO of MicroPhage, said: “The submission of our pivotal study data to the FDA for clearance to market our first test in the US marks a watershed in the commercial development of MicroPhage’s platform technology. Our initial commercial product, in addition to the suite of additional tests we will offer based on our Bacteriophage Amplification platform, represents a new era for the effective and cost-effective testing of hospital patients.
“We believe that our initial test will therefore be embraced by clinicians in Europe and the US as a fresh benchmark in S. aureus identification and antibiotic susceptibility testing. We already are seeing evidence of market acceptance with our first commercial shipments outside the US.”