Curetis receives U.S. FDA 510(k) clearance of Unyvero LRT for BAL specimens

Curetis N.V., a developer of next-level molecular diagnostic solutions, announced 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.

“Pneumocystis jirovecii is a leading cause of pneumonia in immunocompromised individuals. 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 and/or trophic forms on stained respiratory specimens,“ said Richard G. Wunderink, MD, Professor of Medicine, Pulmonary Critical Care, Northwestern University Feinberg School of Medicine, and Medical Director, Medical ICU, Northwestern Memorial Hospital. “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.”

Indiscriminate overuse and misuse of antibiotics are key drivers of dramatically spreading antibiotic resistance, a substantial global health threat. A report recently issued by the Centers for Disease Control and Prevention (CDC) revealed that drug-resistant bacteria and fungi cause almost 3 million infections and 35,000 deaths a year in the United States, meaning that antibiotic-resistant pathogens cause a serious infection every 11 seconds and a death every 15 minutes.

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.

“Unyvero LRT had already been cleared by the U.S. FDA for tracheal aspirate samples in April 2018,” said Johannes Bacher, COO of Curetis. “With our new Unyvero LRT BAL Application Cartridge, clinicians and hospitals can now also test bronchoalveolar lavage samples. 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.”

“We expect that the clearance of our LRT panel for BAL samples will significantly increase the total addressable market for our Unyvero System in the U.S.,” said 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.”

With commercial launch preparations underway, the Company expects to make Unyvero LRT BAL broadly available to U.S. customers in Q1-2020.

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