MicroPhage Successfully Completes Beta Trial for Rapid...( LONGMONT Colo. Jan. 13 /- A new b...),Health

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.

(Photo: http://www.newscom.com/cgi-bin/prnh/20090113/AQTU542)

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 # NCT00814151.

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
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