NEW YORK ─ Scope Fluidics said Thursday it has obtained CE marking for its BacterOmic system to diagnose the antimicrobial susceptibility of bacteria that cause respiratory, blood, urinary tract, and skin infections, among others.
The BacterOmic system, available for use in the European Union, will soon be offered as part of an early-access program, the Warsaw, Poland-based firm said.
During testing conducted by independent clinical centers, the system showed more than 90 percent compliance while assessing susceptibility for 20 antibiotics, the firm said, adding that it plans to expand the system to include susceptibility testing for additional antibiotics.
The BacterOmic system combines microfluidics, detection, data analysis, and automation to provide classical microdilution culture-based antibiotic susceptibility testing, the firm said. The core microfluidic technology splits a suspension of bacteria from a patient sample into 640 microchambers. Each microchamber provides an isolated setting for culturing aerobic or facultatively anaerobic bacteria without the transfer of reagents or bacteria between microchambers, the firm said.
Marcin Izydorzak, vice president and cofounder of Scope Fluidics, said in a statement that the BacterOmic system "ultimately might be able to test all clinically significant antibiotics in one test."