Time is of the essence when it comes to life-threatening illnesses like pneumonia. Curetis N.V. completed Food and Drug Administration clinical trials of its Unyvero Instrument Platform and Unyvero Lower Respiratory Tract Cartridge this week. The technology can help rapidly identify the bacteria and viruses that lead to life-threatening respiratory conditions.
Pneumonia is a serious condition with a 36 percent mortality rate; this includes patients who are hospitalized. The average hospital stay for a bout with the illness is 11 to 14 days.
A quick diagnosis is critical for better patient outcome. With the Unyvero, diseases such as pneumonia, implant or tissue infections are diagnosed within four to five hours. In its FDA trial, the Unyvero platform met the primary endpoint by demonstrating an overall weighted average sensitivity of 90.2 percent and an overall average weighted specificity of 99.3 percent.
Unyvero’s three-part-system includes the Unyvero L4 Lystear, the Unyvero A50 analyzer, and the Unyvero C8 Cockpit.
The Unyvero L4 Lystear takes a patient’s tissue sample and breaks down the cell membrane. Next, the Unyvero A50 analyzes the broken-down sample using three types of cartridges: The Unyvero P55, the i60 ITI Cartridge, and the BCU Cartridge. The cartridge has an “8 labs on 8 chips in a brick” design. The Unyvero Cockpit connects the Unyvero Lysator and Analyzer and includes a touchscreen and barcode reader for quickly entering and securing data. The cockpit also uses a software that gives users step-by-step guidance.
The trial included 2,203 prospective and retrospective samples and 5,694 Unyvero cartridges. Tracheal aspirate and bronchoalveolar lavage samples were collected at nine sites in the U.S. Of those samples, 1,654 were prospectively tested and 549 retrospectively tested with the cartridge using a standard-of-care microbiology culture and additional molecular diagnostic assays.
The study is complemented by data from more than 400 contrived samples from well-characterized pathogen strains obtained from several international strain providers. These strains were spiked into negative patient samples and are being tested at several clinical trial sites to provide additional data points for certain rare pathogens.
Overall, more than 1,100 samples tested positive for one or more pathogens on the LRT panel. Data was available from Unyvero Cartridges, from microbiology culture and from independent molecular testing using PCR and sequencing, resulting in a total of more than 350,000 data points. These data are fully consistent and in line with the performance evaluation previously conducted by Curetis for CE IVD marking in Europe, as well as published data from various European KOLs and customer sites.
Based on this data, Curetis is now preparing its final package for a 510(k) submission for the Unyvero Platform and the LRT Cartridge to the U.S. FDA in due course. The company is expecting feedback from the FDA in the first half of 2017.
“We are truly excited about completing the study on time and as planned and generating a strong and very comprehensive data set,” said Dr. Oliver Schacht, CEO of Curetis. “We have now started compiling the final submission documents and are looking forward to receiving feedback from the FDA. We will be working closely with the agency in the coming months.”