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Article: MicroPhage Opens Pivotal FDA Study on Bacterial Identification Platform.
- Article from:
- Business Wire
- Article date:
- August 20, 2009
CopyrightCOPYRIGHT 2009 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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LONGMONT, Colo. -- MicroPhage announced today the launch of its multi-site clinical trial to support a U.S. Food and Drug Administration (FDA) premarket notification [510(k)]. The platform has been developed to rapidly identify bacterial infections and determine antibiotic susceptibility or resistance to aid physicians in antibiotic management. The company's first product is designed to rapidly identify Staphylococcus aureus (staph) bacteria and determine methicillin resistance (MRSA) or susceptibility (MSSA) in suspected cases of bacteremia - bacteria in the blood, in as little as 5 hours. Today's standard of care for determining these types of infections takes up to ...