Curetis NV, Amsterdam, the Netherlands, has been granted FDA premarket notification (510(k)) clearance to market its Unyvero system and lower respiratory tract (LRT) infection application cartridge in the United States.
Together with the Unyvero LRT application cartridge, the sample-to-answer Unyvero system provides infectious disease test results directly from aspirate samples in less than 5 hours. The LRT cartridge covers more than 90% of patients hospitalized with infectious pneumonia, and provides clinicians with a comprehensive overview of all genetic antibiotic resistance markers detected. According to the company, clearance of the LRT cartridge marks the first time that FDA has granted clearance for an automated molecular diagnostic test for the atypical microorganismLegionella pneumoniae.
Curetis expects to place 60 to 80 Unyvero analyzers in the United States within its first full year of commercial availability.
“The launch of our Unyvero system and LRT application cartridge in the United States will address a pressing unmet medical need, as it delivers results much faster than current standard-of-care microbiology culture,” says Johannes Bacher, cofounder and chief operating officer of Curetis.
To support the company’s premarket notification submission, data from a clinical trial that included more than 2,200 patient samples from nine participating US hospitals were submitted to FDA in early 2017. Curetis’ clinical trial operations team worked in close collaboration with FDA’s review team to evaluate the study dataset and develop relevant statistics and reports, as well as a risk-benefit analysis.
“The LRT application is the first cartridge for our Unyvero system that has been approved in the United States,” says Oliver Schacht, PhD, chief executive of Curetis. “Preparations for another prospective multicenter clinical trial for a second Unyvero application are already underway.”
For more information, visit Curetis.