LONGMONT, Colo., Jan. 13 /PRNewswire/ -- A new bacterial identification test that rapidly identifies MRSA infections moved closer to market with conclusion of its first multicenter clinical trial, which was announced today by MicroPhage, Inc., http://www.microphage.com. The company also reported the trial results have surpassed its early-stage performance expectations.
The beta-site study evaluated MicroPhage's 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, which are
scheduled to begin early this year. Beta sites included
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. "Our prototype assay performed like a market-ready test for identification of MRSA, producing excellent results with regard to specificity," said Smith. "We are confident the final manufactured product will be robust and meet the demands of the clinical laboratory market and the scrutiny of the FDA." He added that the system is expected to be available to US hospitals later this year.
The field trials confirm previous 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. That research showed the 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 requires no 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 measures antibiotic susceptibility/resistance.
MicroPhage has adapted bacteriophage-amplification technology, a natural biologic process, for identifying bacterial infections. "Phages" are bacteria-specific viruses that multiply aggressively when exposed to target bacteria. In 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 that 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. Further information about the technology is available at http://www.microphage.com/technology.
Based in Longmont, Colo. and privately held, MicroPhage, Inc. is working to be a global leader in developing rapid diagnostics products for bacterial identification and antibiotic susceptibility/resistance testing. Using its proprietary bacteriophage-based amplification platform, the company has developed a patented process that is a product platform or engine for rapid, easy-to-use, inexpensive diagnostic tests. Its first products, expected in late 2009, will set a new standard for clinicians in MRSA identification and antibiotic susceptibility testing, and are designed to fit the demands of hospitals and laboratories of all sizes. For further information, go to http://www.microphage.com.
|SOURCE MicroPhage, Inc.|
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