Curetis said it plans to launch its Unyvero System and Lower Respiratory Tract Infection (LRT) Application Cartridge in the U.S. this quarter after the FDA granted the molecular diagnostic a De Novo clearance.
The FDA nod marks the first time the agency has granted clearance to market an automated molecular diagnostic test for the atypical microorganism Legionella pneumoniae, and other lower respiratory tract infections, Curetis said.
The sample-to-answer Unyvero System consists of the Unyvero L4 Lysator, the Unyvero A50 Analyzer and the Unyvero C8 Cockpit. The system also includes a special operating software, corresponding accessories and disposable cartridges for the detection of infectious diseases.
The System, which includes the Unyvero LRT Application Cartridge, offers 29 multiplexed PCR assays designed to detect more than 30 Gram-positive and Gram-negative bacterial organisms known to cause lower respiratory tract infections, as well as 10 genetic markers for antibiotic resistance, including carbapenem and 3rd generation cephalosporins.
According to Curetis, the test 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.
The Unyvero System and LRT Cartridge are designed to provide rapid infectious disease testing directly from aspirate samples in under five hours.
"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", Curetis co-founder and COO Johannes Bacher said in a statement.
The FDA granted its clearance based on data submitted last year from a clinical trial that included more than 2,200 patient samples at nine U.S. hospitals. In addition to working with the FDA to evaluate study data and develop statistics and reports, Curetis said, its clinical trial operations team partnered with “several renowned U.S. clinical experts” who offered input and support for a benefit-risk analysis for the test.
“Preparations for another prospective multi-center clinical trial for a second Unyvero application are already underway,” added Curetis CEO Oliver Schacht, Ph.D.
Following the initial clearance of the LRT application, Curetis said it intends to submit to the FDA an application for a label claim extension which would include the bronchoalveolar lavage (BAL) sample types, for use with the LRT Cartridge, as well as several additional diagnostic targets.
Preparations for a future submission of BAL sample types are progressing, Curetis said, with plans to request a pre-submission meeting “in due course.” The company said it is also collecting patient samples for a multi-center FDA study for its Unyvero IJI Cartridge for the detection of invasive joint infections, and working to develop additional Unyvero cartridges designed for rapid diagnosis of microbial and viral infections.
60 to 80 Placements
Curetis said its commercial launch of the Unyvero test and LRT cartridge will start early in the second quarter, with initial placement opportunities also expected during Q2. The company has set a goal of placing 60 to 80 Unyvero Analyzers with customers in the U.S. within the first full year of commercial availability.
The company added that it will make “additional and accelerated” investments in the U.S. To that end, Curetis has committed to exploring and preparing for strategic and tactical options to finance its commercial roll-out in the U.S., as well as its other operations.
Amsterdam-based Curetis has a team of more than 20 professionals already in place at its Curetis USA subsidiary in San Diego. They include U.S. executive leadership, regional sales directors, clinical application specialists, and field-based territory sales managers and service engineering and logistics support.
“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,” stated Chris Bernard, President and CEO of Curetis USA and EVP Global Sales.
Donna Mildvan, M.D., infectious diseases physician and clinical professor of medicine at Icahn School of Medicine at Mount Sinai, predicted that the LRT panel is expected to “transform our approach to the diagnosis of lower respiratory tract infections.”
"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."
Dr. Mildvan is one of five U.S.infectious disease experts appointed by Curetis to its new U.S. Scientific Advisory Board, founded to support clinical adoption of Unyvero System and Unyvero LRT Application Cartridge. The other four are Debra Goff, Pharm.D., of The Ohio State University and Wexner Medical Center; Melissa Miller, Ph.D., of University of North Carolina at Chapel HillSchool of Medicine; Frederick Nolte, Ph.D., of Medical University of South Carolina; and Robin Patel, M.D., of the Mayo Clinic in Rochester, MN.