MicroPhage announced today that it has obtained its CE Mark to market in Europe the first of its instrument-free, rapid tests based on its patented Bacteriophage Amplification technology. The Company’s initial commercial product 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 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.
“Our initial product, as well as the family of tests we intend to offer based on our Bacteriophge Amplification platform, represents a new paradigm for the effective, cost-effective testing of hospital patients,” said MicroPhage CEO, Steve Lundy. “Hospital-acquired infections (HAIs) are a colossal problem, killing more than 15 million1 persons worldwide each year and costing the U.S. $29 billion2 in unnecessary health care expense. We believe that our initial test will be extremely well received in Europe as well as in the U.S.