MicroPhage's new platform for rapid identification of bacterial infections

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 three days.

The MicroPhage test platform 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 a dual dipstick-like detector, which looks much like a pair of home pregnancy tests. One part of the detector shows if the sample is infected with S. aureus bacteria and the other shows if it is susceptible or resistant to the antibiotic. Results allow for more precise antibiotic therapy for a condition that has a mortality rate of 20% or more. Delivering this diagnostic information quickly will enable physicians to prescribe more effective and precise antibiotics that could shorten hospital stays, lower rising health care costs, and ultimately save lives.

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. The MicroPhage test will be compared to a laboratory “gold standard” test to determine performance. It is expected to be completed in the fourth quarter of this year.

“This is a very exciting time for our company,” said MicroPhage CEO, Steve Lundy. “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.”