Curetis NV has launched its Unyvero sample-to-answer molecular diagnostic system and the Unyvero LRT Application Cartridge for lower respiratory tract infections.
The Unyvero System, together with the Unyvero LRT Application Cartridge, provides rapid infectious disease testing directly from aspirate samples in less than five hours. It covers more than 90% of infection cases of hospitalized pneumonia patients and provides clinicians with a comprehensive overview of genetic antibiotic resistance markers detected.
As the first-in-class molecular test for lower respiratory tract infections with no direct molecular diagnostic competition, it addresses a significant unmet medical need that causes over $10bn in annual costs for the U.S. healthcare system. It is also the first time that the U.S. FDA has granted clearance for an automated molecular diagnostic test for the atypical microorganism Legionella pneumoniae.
“ASM Microbe is an ideal platform to launch the Unyvero System and the LRT Application Cartridge in the US,” said Chris Bernard, president and CEO of Curetis USA Inc. “We are making very good progress in getting Unyvero Systems installed in several of those accounts short-term and expect to have signed multiple commercial evaluation agreements in the coming weeks. We also received the first commercial Unyvero cartridge order from a US customer.”
Curetis is targeting the placement of 40 to 50 Unyvero Analyzers by year-end 2018 and 60 to 80 analyzers within the first full year of commercial availability in the US.