Curetis Receives FDA De Novo Clearance of Unyvero System and Unyvero LRT Infection Cartridge

Curetis N.V., a developer of next-level molecular diagnostic solutions, has been granted de novo clearance by the U.S. Food and Drug Administration (FDA) to market the Unyvero System and Lower Respiratory Tract Infection (LRT) Application Cartridge in the United States.
 
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 percent of infection cases of hospitalized patients with pneumonia and provides clinicians with a comprehensive overview on genetic antibiotic resistance markers detected. As the first-in-class molecular test for lower respiratory tract infections with no direct MDx competition, it addresses a high unmet medical need that generates over $10 billion in annual costs for the U.S. healthcare system.^1,2 It is also the first time the FDA has granted an automated molecular diagnostic test for the atypical microorganism Legionella pneumoniae. In sum, Unyvero is expected to impact clinical outcomes, support antibiotic stewardship and create health economic benefits.
 
The company has a team of more than 20 seasoned experts already in place at its Curetis USA Inc. subsidiary in San Diego, Calif. These experts include the U.S. executive leadership, regional sales directors, clinical application specialists, and field-based territory sales managers and service engineering and logistics support. Commercial roll-out will start early in the second quarter, with initial placement opportunities expected in the same quarter. Curetis targets to place 60 to 80 Unyvero Analyzers in the United States within the 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”, Curetis co-founder and Chief Operating Officer Johannes Bacher said.
 
“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 in New York City. “Having the opportunity to characterize pneumonia by knowing the causative organism as well as relevant antibiotic resistance markers in four to five hours has great clinical implications—it is game changing and exciting.”
 
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.
 
“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”, said Oliver Schacht, Ph.D., CEO of Curetis.
 
Curetis intends to submit an application for a label claim extension following this initial clearance of the LRT application, which would include the bronchial lavage (BAL) sample types, as well as several additional diagnostic targets. In addition, further to the already significant investments in its U.S. operations in anticipation of the FDA approval, Curetis will make additional and accelerated investments in the United States. Therefore, Curetis will continue to explore and prepare for strategic and tactical options to finance its commercial roll-out in the United States and its other operations.
 
“We have assembled a team of 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 Unyvero Solution to clinicians, microbiologists in clinical laboratories, and above all to patients in the Unites States”, commented Chris Bernard, president and CEO of Curetis USA Inc. and executive vice president Global Sales.
 
The Unyvero System with the Unyvero LRT Cartridge is the first, most comprehensive molecular diagnostics (MDx) product for lower respiratory tract infections that has been granted clearance by the FDA. With 29 multiplexed PCR assays it can 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. Preparations for a future submission of bronchoalveolar lavage (BAL) sample types for use with the LRT Cartridge are progressing, and the company intends to request a pre-submission meeting in due course. The company also is already collecting patient samples for a multi-center FDA study for its Unyvero IJI Cartridge for the detection of invasive joint infections. Further, Unyvero Cartridges with unique panels designed for the rapid diagnosis of microbial and viral infections are in preparation.
 
Curetis N.V. is a provider of solutions for molecular microbiology designed to address the global challenge of diagnosing severe infectious diseases and identifying antibiotic resistances in hospitalized patients.
 
Curetis’ Unyvero System is a versatile, fast and highly automated molecular diagnostic platform for easy-to-use, cartridge-based solutions for the comprehensive and rapid detection of pathogens and antimicrobial resistance markers in a range of severe infectious disease indications. Results are available within hours, a process that can take days or even weeks if performed with standard diagnostic procedures, and thereby facilitates improved patient outcomes, stringent antibiotic stewardship and health economic benefits. Unyvero in-vitro diagnostic (IVD) products are marketed in Europe, the Middle East, Asia, and in the United States.
 
Curetis’ wholly-owned subsidiary Ares Genetics GmbH offers next-generation solutions for infectious disease diagnostics and therapeutics. ARES’ technology platform combines the world’s most comprehensive database on the genetics of antimicrobial resistances with advanced bioinformatics and artificial intelligence.

References
1. CDC (2015) ‘New CDC study highlights burden of pneumonia hospitalizations among US adults’, available at: https://www.cdc.gov/media/releases/2015/p0714-pneumonia-hospitalizations.html
2. American Thoracic Society (2015) ‘Top 20 pneumonia facts – 2015’, available at: https://www.thoracic.org/patients/patient-resources/resources/top-pneumonia-facts.pdf