Curetis N.V. announced that the Company has received 510(k) clearance by the U.S. Food and Drug Administration (FDA) to market its Unyvero LRT Lower Respiratory Tract Application Cartridge for use with bronchoalveolar lavage (BAL) samples to diagnose lower respiratory tract infections such as pneumonia. The LRT BAL panel detects a broad spectrum of clinically relevant causative agents, including atypical pathogens, as well as antibiotic resistance markers. Thereby, it provides clinicians with a valuable diagnostic tool that informs early and supports appropriate antibiotic treatment decisions in this indication. Infections with atypical pathogens are often associated with community-acquired pneumonia (CAP), but are not considered in the context of hospital-acquired or ventilator-associated pneumonia. Therefore, hospitalized patients usually are not tested for these organisms unless there is a suspicion of infection. Further, empiric treatment of these patients does not normally cover atypical pathogens. Unyvero LRT BAL expands the diagnostic capability of clinicians to routinely identify atypical infections that might otherwise escape detection and hence can prevent prolonged inappropriate treatment of patients. Furthermore, the Unyvero LRT BAL application is the first and only FDA cleared molecular diagnostic pneumonia panel that includes Pneumocystis jirovecii. As culture-based diagnosis of Pneumocystis jirovecii Pneumonia (PJP) is not possible, identification of this pathogen is often based on morphological detection techniques, which are labor-intensive and time-consuming and lack sensitivity. Rapid diagnosis of PJP, which causes severe and life-threatening symptoms, is crucial in patients with a weak or suppressed immune system. Initiating the appropriate therapy even one day earlier can significantly reduce mortality in this patient group. By providing a fast and reliable solution for the rapid detection of pathogens and antibiotic resistance markers, Unyvero LRT BAL is an essential, indispensable tool for targeted antimicrobial therapy improving patient outcomes while facilitating stringent antibiotic stewardship. With commercial launch preparations underway, the Company expects to make Unyvero LRT BAL broadly available to U.S. customers in the first quarter of 2020.