February 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.
Curetis expects to make the panel available to U.S. customers in the first quarter of this year.
Curetis, 619-452-3644