Jan. 7, 2020—Curetis announced it has received FDA 510(k) clearance to market its Unyvero LRT Lower Respiratory Tract application cartridge for use with bronchoalveolar lavage samples to diagnose lower respiratory tract infections such as pneumonia.
The Unyvero LRT BAL application is the first FDA-cleared molecular diagnostic pneumonia panel that includes Pneumocystis jirovecii, the company reports. The panel detects a broad spectrum of clinically relevant causative agents, including atypical pathogens, as well as antibiotic resistance markers.
“Pneumocystis jirovecii is a leading cause of pneumonia in immunocompromised individuals. Several features unique to pneumocystis make its diagnosis difficult,” Richard G. Wunderink, MD, professor of medicine, pulmonary and critical care, Northwestern University Feinberg School of Medicine, and medical director, medical ICU, Northwestern Memorial Hospital, said in a Curetis press release. “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 and/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.”
Curetis expects to make the Unyvero LRT BAL panel available to U.S. customers in the first quarter of this year.