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FDA Clears Curetis Lower Respiratory Tract Infections Panel

NEW YORK – Curetis said after the close of the market on Friday that the US Food and Drug Administration has cleared the company's Unyvero LRT lower respiratory tract application cartridge for marketing in the US.

The device was cleared for use with bronchoalveolar lavage (BAL) samples for the diagnosis of lower respiratory tract infections including pneumonia. The LRT BAL panel detects a wide spectrum of clinically relevant causative agents, such as atypical pathogens and antibiotic resistance markers, providing clinicians with a diagnostic tool that provides information early in the decision-making process and support in antibiotic treatment decisions, the German diagnostics firm said in a statement.

It noted that the Unyvero LRT BAL application is the "first and only FDA-cleared" molecular panel that includes Pneumocystis jirovecii. Culture-based diagnosis of P. jirovecii is not possible and its identification relies on morphological detection methods, which Curetis said are labor intensive, time consuming, and lack sensitivity.

P. jirovecii is a major cause of pneumonia in immunocompromised patients, and inclusion of the fungus in a "rapid comprehensive molecular panel for BAL … will greatly facilitate our ability to quickly diagnose and treat these patients," said Richard Wunderink, professor of medicine, pulmonary critical care at Northwestern University Feinberg School of Medicine and medical director, medical ICU at Northwestern Memorial Hospital, in a statement.

"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 US," added Oliver Schacht, 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." 

Curetis, which is being acquired by OpGen, expects to make the panel broadly available in the US in Q1 2020.