First Rapid Diagnostic Platform for Respiratory Infections Gets FDA Nod
Dutch molecular diagnostics company, Curetis, has now received the FDA approval for its multiplex assay to detect lower respiratory tract infections, as well as for the firm’s molecular diagnostic platform, Unyvero. The assay is the first multiplex lower respiratory tract infection test to be cleared by the FDA.
“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“, said Curetis’ co-founder and Chief Operating Officer Johannes Bacher.
“We expect that the LRT panel will transform our approach to the diagnosis of lower respiratory tract infections“, said Dr. Donna Mildvan, Infectious Diseases Physician and Clinical Professor of Medicine at Icahn School of Medicine at Mount Sinai, New York, NY. “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 sample-to-answer Unyvero System together with the Unyvero LRT Application Cartridge provides rapid infectious disease testing directly from aspirate samples in under five hours
. It covers more than 90% of infection cases of hospitalized patients with pneumonia and provides clinicians with a comprehensive overview on genetic antibiotic resistance markers detected.Data from a clinical trial, which included more than 2,200 patient samples at nine participating U.S. hospitals, were submitted to the FDA in early 2017. Curetis’ clinical trial operations team has worked in close collaboration with the FDA’s review team to evaluate the study data set and develop relevant statistics and reports, as well as a benefit-risk analysis which was compiled with input and support from several renowned U.S. clinical experts.
Curetis further 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.