MicroPhage has launched its multi-site clinical trial to support a 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.
Reportedly, the study will involve seven major medical centers throughout the country and is expected to test more than 2,000 specimens to demonstrate its safety and performance. It is expected to be completed in the fourth quarter of this year.
Steve Lundy, CEO of MicroPhage, said: “This is a very exciting time for our company. We are excited about our prospects to provide health care providers with rapid, actionable information to fight the rising tide of hospital acquired infections while lowering health care costs. We look forward to this Trial and getting to market later this year.”