MicroPhage seeks FDA clearance for MRSA/MSSA Blood Culture Test, submits clinical study data

Mar 5 2010

MicroPhage announced that it has submitted human data from a pivotal clinical study of its ‘Microphage MRSA/MSSA Blood Culture Test’ to support a U.S. Food and Drug Administration (FDA) 510(k) premarket notification process. The first of MicroPhage’s instrument-free, rapid tests is based on the Company’s patented Bacteriophage Amplification platform technology. MicroPhage further announced that it has already begun OUS commercial shipments of the test.

The Company’s initial commercial product—‘Microphage MRSA/MSSA Blood Culture Test’—which has previously received regulatory clearance (CE Mark) to be sold in Europe, is designed to rapidly identify Staphylococcus aureus (“staph”) bacteria as well as determine methicillin resistance (MRSA) or susceptibility (MSSA) in suspected cases of bacteremia—bacteria in the blood—in as little as five hours. Today’s standard of care for determining these types of infections takes up to three days for test-results, which can result in ineffective treatment, bacterial resistance, and death.

“The submission of our pivotal study data to the FDA for clearance to market our first test in the United States 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,” said MicroPhage CEO, Steve Lundy. “Hospital-acquired infections (HAIs) are a formidable challenge, killing millions of patients worldwide each year while generating billions of dollars in unwarranted health care expenses. We strongly believe that our initial test will therefore be embraced by clinicians in Europe and the United States 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 U.S.”

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 are 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 percent.