MicroPhage recently received its CE Mark for selling and distributing the first of its instrument-free, rapid staph infection testing products in Europe. Based on its Bacteriophage Amplification technology, the product is designed to identify Staphylococcus aureus (staph) bacteria as well as determine methicillin resistance (MRSA) or susceptibility (MSSA) in suspected cases of bacteremia-bacteria in the blood. According to the company, these tests can be conclusive in as little as five hours, versus the three days for current test results.
The MicroPhage MRSA/MSSA Blood Culture Test requires no instrumentation and begins with two small reaction tubes for incubating blood culture specimens. After five hours, the incubated samples are added to a dual dipstick-like detector that 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. MicroPhage feels delivering this information more quickly will enable physicians to determine more effective and precise antibiotics that could shorten hospital stays, lower health care costs and, ultimately, save lives.
In August, MicroPhage announced the start of a multi-site clinical trial to support its U.S. FDA premarket notification 510(k) submission, which is expected to be filed shortly. The clinical study involves four major medical centers throughout the U.S. and is expected to test more than 1,000 specimens.