Company News: Curetis Completes Sample Enrollment in Unyvero U.S. FDA Trial in Lower Respiratory Tract Infections
– Last patient enrolled in prospective arm of IVD trial
– More than 2,250 prospective and retrospective samples enrolled in study
– Data to be complemented with up to 500 additional contrived samples with focus on rare pathogens
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced the completion of patient enrollment in its Unyvero U.S. FDA trial. The primary endpoint of the prospective and retrospective study is the performance of the Unyvero LRT55 Lower Respiratory Tract cartridge in detecting lower respiratory tract infections as compared to microbiology culture, the current diagnostic standard of care.
In less than a year, a total of 2,254 tracheal aspirate and bronchoalveolar lavage samples have enrolled at nine participating sites across the US, including Mayo Clinic, Northwestern University, Johns Hopkins Hospital, UCLA and Columbia University Medical Center. 1,698 samples were prospectively tested, and 556 were retrospectively tested with the LRT55 Unyvero Lower Respiratory Tract Cartridge as well as using standard of care microbiology culture. The Principal Investigator of the trial is Dr. Robin Patel, Director of the Clinical Bacteriology Laboratory and Infectious Diseases Research Laboratory, and Chair of the Division of Clinical Microbiology at Mayo Clinic.
“Our Clinical Trial Operations team would like to thank all of the participating sites, as well as our Principal Investigator Robin Patel, for their dedicated support during the study,” said Johannes Bacher, Chief Operating Officer of Curetis. “We are proud to conclude patient enrollment this month as planned, after running more than 5,650 Unyvero LRT55 Cartridges in a study with complex sample management logistics.”
“We are very pleased to have finished enrolment of our U.S. study on schedule and according to plan,” said Dr. Oliver Schacht, CEO of Curetis. “In preparing for our IPO during the second half of last year, we outlined a number of anticipated near- and mid-term milestones for the Company. Following the commercial launch of our blood culture (BCU) application cartridge earlier this year, the completion of enrollment in our U.S. trial represents another important accomplishment from that list. I am proud of what our teams have accomplished since becoming a public company, and we look forward to the release of initial top-line data from the study later this year.”
After completion of all molecular comparator testing, data will be unblinded and Unyvero results will be compared against an independent molecular composite comparator based on pathogen DNA analysis by PCR and sequencing. Completion of the analysis is expected in the second half of 2016. Subsequently, a statistical analysis based on more than 350,000 data points combined from microbiology, Unyvero runs, additional molecular testing and bidirectional sequencing will be prepared. FDA submission is anticipated before the end of the year, with a goal of securing FDA clearance for Unyvero and commercialization of the technology in the first half of 2017.
In order to provide additional data points for certain rare pathogens, e.g. Legionella, Mycoplasma, Pneumocystis, up to 500 contrived samples from well characterized pathogen strains from several international strain providers will be spiked into negative matrix and tested with Unyvero at several clinical trial sites. It is expected that this phase will add approximately 1,500 cartridge runs, as double testing will be performed on two systems in parallel for software validation, including daily controls and a number of sample repeats.
LRT55 is a second-generation cartridge based on the design of the CE-IVD marked P55 cartridge marketed outside the U.S. It features 40 markers, a novel control concept and provides the most comprehensive molecular marker panel for lower respiratory tract infections available today.
Further details about the Unyvero platform are available at the Unyvero product website – www.unyvero.com.