People typically go into the hospital to get better, but many patients wind up sicker than when they came in. Hospital acquired infections (HAIs) such as Staphylococcus aureus (“staph”) can be deadly to patients with already weakened immune systems. Approximately 60 percent of patients with S. aureus bacteremia (bacteria in the blood) may be resistant to methicillin-type antibiotics. HAIs kill more than 15 million people worldwide each year and cost the U.S. $29 billion in annual health expenses. Current MRSA/MSSA testing can take up to three days for test results, often resulting in ineffective treatment, bacterial resistance and death. MRSA infections have a mortality rate of over 20 percent.
MicroPhage of Longmont, Colo., has developed a platform of rapid diagnostic tests to identify staph bacteria and determine methicillin resistance (MRSA) and susceptibility (MSSA). The company’s Bacteriophage Amplification technology makes use of bacteriophage, or viruses that amplify bacteria, as a marker for infections. Phage multiply rapidly when exposed to target bacteria.
The MicroPhage MRSA/MSSA Blood Culture Test consists of two small tubes and an indicator. Blood samples are placed in the tubes, mixed, and incubated. When mixed with a patient’s sample, the phage attach to the bacteria present in the blood and then replicate rapidly. After five hours, the blood samples are added to a dual dipstick-like indicator, which resembles a home pregnancy test. The indicator is able to detect the amplified phage proteins in the sample and identify the bacteria. One part of the test will determine whether the patient is infected with Staphylococcus aureus. The other part of the test will determine whether the patient is resistant to methicillin-type antibiotics.
MicroPhage recently received the CE Mark to commercialize its MRSA/MSSA Blood Culture Test in Europe. The company expects to file for 510(k) approval with the U.S. Food and Drug Administration within the next few weeks. In August, MicroPhage announced the start of a multi-center U.S. clinical trial to test the safety and efficacy of the MicroPhage MRSA/MSSA Blood Culture Test.