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Microphage Inc Rapid MRSA Test Moves Closer To Market

A new bacterial identification test which rapidly identifies MRSA infections moved closer to market with conclusion of its first multicenter clinical trial that was announced by MicroPhage Inc. The company also reported the trial results have surpassed its early-stage performance expectations. The beta-site study evaluated the prototype assay to identify Staphylococcus aureus (staph) bacteria and determine methicillin resistance (MRSA) or susceptibility (MSSA) in suspected cases of bacteremia (bacteria in the blood). The research precedes FDA-submission clinical studies that are scheduled to begin early this year. Beta sites included Northshore University Healthcare (IL.), Johns Hopkins University and the University of Maryland Medical School. According to Drew Smith, Ph.D, Director, Research and Development at MicroPhage, test performance at the three sites exceeded all study goals and performed at or near FDA requirements in more than 700 clinical samples. The field trials confirm prior performance studies reported in October at the prestigious joint meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and Infectious Disease Society of America. The research showed that MicroPhage system provides results in five hours versus up to 48 hours for culture testing methods, and had an excellent detection rate for S. aureus bacteria of 93 percent while also determining methicillin resistance or susceptibility at greater than 98 percent reliability. Results of the beta trial were not available for release, pending final analysis and publication. The MicroPhage system doesn’t require any instrumentation and is composed of two small reaction tubes for incubating blood-culture specimens. After five hours, the incubated samples are added to two dipstick-like detectors. One detector shows if the sample is infected with staph bacteria and the other one measures antibiotic susceptibility/resistance. MicroPhage has adapted bacteriophage-amplification technology which is a natural biologic process, for identifying bacterial infections. "Phages" are bacteria-specific viruses which multiply aggressively when exposed to target bacteria. During the detection process, reaction of the bacteriophage proteins on the test strip indicates the sample is positive for staph bacteria. For susceptibility analysis, the organism in the sample is challenged with an antibiotic. Because phages depend on host bacteria for growth, any compound which kills or inhibits the microbe will stop phage growth. Only resistant strains allow multiplication of phages and yield a positive signal on the detector strip.