MicroPhage announces 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%.
“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 million persons worldwide each year and costing the US. $29 billion in unnecessary health care expense. We believe that our initial test will be extremely well received in Europe as well as in the US.
“Our first commercial product establishes a new standard for clinicians in S. aureus identification and antibiotic susceptibility testing, and it is designed to complement the demands of hospitals and laboratories of all sizes,” Lundy added. “We are developing additional tests, including rapid tests for screening of high-risk patients, skin and soft tissue infections, as well as respiratory infections for S. aureus and other bacteria of clinical interest.”
In August, MicroPhage announced the start of a multi-site clinical trial to support its FDA premarket notification 510(k) submission, which is expected to be filed shortly. The clinical study involves four major medical centers throughout the US and is expected to test more than 1,000 specimens with the Microphage MRSA/MSSA Blood Culture Test to demonstrate its safety and performance. The MicroPhage test is being compared to a battery of laboratory “gold standard” tests to determine its performance.