CardiovascularMicroPhage Demonstrates Rapid Diagnostic Platform Feasibility In Skin And Soft Tissue Infections
In a presentation at the current General Meeting of the American Society for Microbiology (ASM) being held in Philadelphia, PA, a simple and inexpensive developmental diagnostic assay produced by MicroPhage, Inc., http://www.microphage.com, was shown to be highly accurate for rapid identification of serious staph bacterial infections from skin and soft tissue infections.
Thirty three samples from a wide array of body sites were collected from the St. Mary-Corwin Hospital in Pueblo Colorado. Of the 33, 8 were determined to have Staphylococcus aureus infections by traditional microbiology methods. Seven of these samples were rapidly detected by the prototype rapid assay by MicroPhage, days before these full results were available.
"We were really excited by these early results," said Drew Smith, Ph.D., MicroPhage Director of Research and Development. "We essentially took a prototype in development for our screening test and applied it to these samples. It demonstrates to us that the platform can easily be adapted to other samples types, which is very encouraging." The results are so compelling that he concludes that a 5 hour result time is likely for this simple to use test.
By contrast, today"s physicians do not have any antibiotic testing information when they prescribe these drugs for suspected infections like these in their patients. Doing so has been shown to increase antibiotic resistance and make treating these infections more and more difficult. The typical turn-around for such a diagnosis is often more than 48 hours. MicroPhage is the first company to present findings that an easy-to-use platform, similar to that of a pregnancy test, could hold the answer, through rapid, accurate tests that could help alleviate the need for antibiotics, or help guide the use of more appropriate antibiotics in hospitals and other clinical settings.
The company plans further development of the test through 2009 and will enter it into FDA clinical trials in early 2010. It is planned that the product will be formatted like its blood culture test, and provide antibiotic susceptibility and resistance results to determine if the S. aureus present is methicillin-resistant (MRSA) or sensitive (MSSA), further directing appropriate therapy. The product is planned to reach the US market later next year.
A Simple and Natural Identification Technology
The MicroPhage system has two incubation 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 staff bacteria and the other indicates antibiotic susceptibility of the bacterial strain.
MicroPhage has adapted a natural biologic process, called bacteriophage amplification technology, for identifying staph infections as its primary products. "Phages" are viruses that multiply aggressively when exposed to the target bacteria. In the identification 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 that kills or inhibits the target bacterium will also prevent phage amplification. Only resistant strains allow amplification of phage and yield a positive signal on the detector strip.
MicroPhage