Curetis Expects Near-Term FDA Decision on De Novo Request
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Review of the Unyvero System and Lower Respiratory Tract (LRT) Cartridge is nearing completion
U.S. commercial team and operational infrastructure in place
Curetis N.V. (the "Company" and, together with Curetis USA Inc. and Curetis GmbH, "Curetis"), a developer of next-level molecular diagnostic solutions, today provided a status update on the FDA De Novo filing for the Company’s Unyvero System and LRT Cartridge for the diagnosis of lower respiratory tract infections.
The FDA and Curetis have agreed on software results screens and disclaimer language in the fourth quarter of 2017 and software implementation of the final reporting format is already underway. In December 2017, the FDA and Curetis also agreed on the format and scope of reporting of clinical and resistance marker data (incl. resistance marker statistics) as part of the labelling (package insert / handbook).
"We are in very close interaction with the FDA’s review team,” said Oliver Schacht, CEO of Curetis. “We are now expecting a near-term decision on our De Novo request for the Unyvero System and Unyvero LRT Cartridge.”
Preparations for a future submission of bronchoalveolar lavage (BAL) sample types for use with the LRT Cartridge are also progressing, and the Company intends to request a pre-submission meeting in due course.
As the FDA review is nearing completion and in anticipation of the FDA decision, the Company has continued to build its U.S. commercial organization in San Diego, CA with the recent hiring of highly experienced key regional sales and commercial support staff.