Curetis AG initiates clinical trial in the U.S. towards FDA clearance
Curetis AG announced the start of a clinical trial of its Unyvero™ System and the corresponding LRT (lower respiratory tract) application in the U.S. The company expects enrollment completion within the next 12-15 months, followed by a 510(k) submission to the FDA in 2014. The prospective, multicenter trial will include samples collected from more than 2,000 hospitalized patients suspected to have a lower respiratory tract infection and several hundred retrospective samples with known microbiology culture results for rare pathogens. Samples will be processed by the Unyvero™ Lysator, transferred to the LRT cartridge, and tested by the Unyvero™ Analyzer.
Primary endpoint of the study will be assay performance defi ned as clinical sensitivity and specifi city compared to microbiology culture (today’s diagnostics standard of care) and to a composite reference diagnosis that incorporates PCR and sequencing to determine clinical truth whenever microbiology culture results are negative. Trial sites include Northwestern University (Chicago, IL) and North Shore-LIJ Health System (Lake Success, NY), among others. The Principal Investigator is Prof. Christine C. Ginocchio, Senior Medical Director and Chief, Division of Infectious Disease Diagnostics, North Shore-LIJ Health System. Curetis has contracted Aptiv Solutions as its CRO and Neil Mucci of GlobalBioclinical as project manager in the US. “With shipment of instruments and cartridges and training of the fi rst sites completed, we expect the fi rst three sites to be initiated during the next few weeks,” said Oliver Schacht, CEO of Curetis. “
Based on an intensive and engaged dialog with the FDA and our regulatory affairs advisors over the past 24 months, we have designed a study protocol to meet FDA requirements. We are very happy that we were able to effectively establish a path forward for our highly multiplexed, PCR-based cartridge.” “With current standard microbiology, it takes up to 72 hours to provide the clinician with initial information on the types of organisms causing a life-threatening infection and also the appropriate antibiotics that can be used as treatment,” said Christine Ginocchio. “This can delay appropriate therapy and if a patient is not treated with an appropriate antibiotic regimen from the beginning, this can result in increased morbidity and mortality. We are therefore very much looking forward to test the Unyvero System. Faster, accurate and reliable testing will be of tremendous clinical benefi t and greatly improve the quality of patient care.”
The LRT application analyzes 39 DNA targets simultaneously from a single patient sample. Results are available within about 4 hours. The pathogen panel has been selected for clinical relevance based on current international clinical guidelines and has been reviewed by clinical experts in Europe and the USA. Resistance genes were chosen by frequency and clinical signifi cance. A similar product, the Unyvero™ P50 pneumonia cartridge is CE-marked and currently marketed in Europe and the Middle East.