Molecular diagnostics company Curetis said today that it won a de novo clearance from the FDA for its Unyvero System and lower respiratory tract infection cartridge.
Combined with the cartridge, the Unyvero System evaluates samples for the presence of infectious respiratory disease in under five hours. The device can also tell doctors if it detects any genetic antibiotic resistance markers.
Curetis touted that this regulatory win is the first time the U.S. agency has granted an automated molecular diagnostic test for Legionella pneumoniae.
The company plans to launch the product in the second quarter of 2018 and hopes to place 60 – 80 Unyvero Analyzers in the U.S. in the first 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,” co-founder & COO Johannes Bacher said in prepared remarks.
“We expect that the LRT panel will transform our approach to the diagnosis of lower respiratory tract infections,” Dr. Donna Mildvan, a physician & professor at the Icahn School of Medicine at Mount Sinai in New York, added. “Having the opportunity to characterize pneumonia by knowing the causative organism as well as relevant antibiotic resistance markers in 4 to 5 hours has great clinical implications – it is game changing and exciting.”
“The LRT application is the first cartridge for our Unyvero System that has been approved in the U.S. Preparations for another prospective multi-center clinical trial for a second Unyvero application are already underway,” CEO Oliver Schacht said.
Curetis also plans to submit an application to the FDA for an expanded label on its diagnostic system, which would include clearance for bronchial lavage sample types and additional diagnostic targets.
“We have assembled a team of high-caliber talent here at Curetis USA, and we will continue to expand our commercial organization in support of the Unyvero product launch in Q2/2018. We are truly excited to bring the innovative Unyvero Solution to clinicians, microbiologists in clinical laboratories, and above all to patients in the Unites States,” Chris Bernard, president & CEO of Curetis USA Inc. and EVP of global sales, said.