MicroPhage successfully completes beta trial for rapid MRSA test
21 January 2009
MicroPhage has announced that its new bacterial identification test
that rapidly identifies MRSA infections has concluded its first
multicenter clinical trial. 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 Johns Hopkins
University, Northshore University Healthcare (IL.), and the University
of Maryland Medical School. More information on the study is available
on the National Institute of Health's ClinicalTrials.gov website, study
According to Dr Drew Smith, 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 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% while
also determining methicillin resistance or susceptibility at greater
than 98% 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
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.
Bookmark this page