FDA has granted premarket notification (510(k)) clearance to the Unyvero lower respiratory tract (LRT) application cartridge from Curetis, Holzgerlingen, Germany, for use with bronchoalveolar lavage (BAL) samples to diagnose lower respiratory tract infections such as pneumonia.
The Unyvero LRT BAL panel detects a broad spectrum of clinically relevant causative agents, including atypical pathogens as well as antibiotic-resistance markers. The panel offers clinicians a valuable diagnostic tool that supports appropriate antibiotic treatment decisions.
Richard G. Wunderink, MD, Northwestern University’s Feinberg School of Medicine.
Infections with atypical pathogens are often associated with community-acquired pneumonia, but are not usually considered in the context of hospital-acquired or ventilator-associated pneumonia. Hospitalized patients are therefore not tested for such organisms unless there is a suspicion of infection. Further, empiric treatment of hospitalized patients does not normally cover atypical pathogens. The Unyvero LRT BAL panel expands the capability of clinicians to diagnose atypical infections that might otherwise escape detection, and hence can prevent prolonged inappropriate treatment of patients.
Johannes Bacher, Curetis.
The Unyvero LRT BAL panel is the only FDA-cleared molecular diagnostic that includes Pneumocystis jirovecii, the causative agent of P. jirovecii pneumonia. As culture-based diagnosis of P. jirovecii pneumonia is not possible, identification of this pathogen is often based on morphological detection techniques, which are labor-intensive, time-consuming, and lack sensitivity. Rapid diagnosis of P. jirovecii pneumonia, which causes severe and life-threatening symptoms, is crucial in patients with a weak or suppressed immune system. Initiating appropriate therapy even 1 day earlier can significantly reduce mortality in this patient group.
Oliver Schacht, PhD, Curetis.
“Pneumocystis jirovecii is a leading cause of pneumonia in immunocompromised individuals,” says Richard G. Wunderink, MD, professor of medicine at Northwestern University’s Feinberg School of Medicine. “Several features unique to Pneumocystis make its diagnosis difficult. No combination of symptoms, signs, and chest radiographic findings is diagnostic of Pneumocystis pneumonia. The organism cannot be cultured, and its diagnosis currently relies on microscopic visualization of the characteristic cysts or trophic forms on stained respiratory specimens.
“Inclusion of Pneumocystis jirovecii in a rapid comprehensive molecular panel for BAL—the preferred diagnostic procedure for Pneumocystis pneumonia—will greatly facilitate our ability to quickly diagnose and treat these patients,” says Wunderink.
FDA previously cleared the Unyvero LRT panel for use with tracheal aspirate samples. “With our new Unyvero LRT BAL application cartridge, clinicians and hospitals can now also test bronchoalveolar lavage samples,” says Johannes Bacher, COO of Curetis. “This sample type accounts for about half of the samples obtained for the diagnosis of lower respiratory tract infections such as pneumonia. As a result, our Unyvero solution is offering the most comprehensive multiplex molecular panel for the rapid diagnosis of bacteria and fungi associated with severe pneumonia. It not only enables rapid and simultaneous detection of pathogens, but also offers the broadest coverage of resistance markers.”
FDA-cleared Unyvero panel for pneumonia.
“We expect that clearance of our LRT panel for BAL samples will significantly increase the total addressable market for our Unyvero system in the United States,” says Oliver Schacht, PhD, CEO of Curetis. “It will provide us with substantial opportunities to place Unyvero instruments for rapid testing of patients with suspected lower respiratory tract infections. Moreover, by providing laboratorians and clinicians with a powerful diagnostic tool to identify pathogens in lower respiratory tract infections earlier, faster, and more reliably, Unyvero supports antibiotic stewardship efforts to avoid the unnecessary use of antibiotics.”
Curetis expects the Unyvero LRT BAL panel to be broadly available in the United States in early 2020. For more information, visit Curetis.
