MicroPhage Inc. out of Longmont, Colorado, a company that develops technology for bacterial identification, has announced positive results from a study of its 5 hour MRSA detection system.
The company explains the study and technology behind the test:
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 Johns Hopkins University, Northshore University Healthcare (IL.), 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. “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.
Product page: MRSA screening test
Press release: MicroPhage Successfully Completes Beta Trial for Rapid MRSA Test (.pdf)
Study info page at ClinicalTrials.gov…
