NEW YORK — German molecular diagnostics firm Curetis said today that it has filed for 510(k) clearance with the US Food and Drug Administration for its Unyvero lower respiratory tract (LRT) infection test for use with bronchoalveolar lavage.
According to Curetis, the test covers 50 targets with 30 PCR-based assays for clinically relevant pathogens and markers of antibiotic resistance. It runs on the Unyvero system, which was cleared by the FDA in early 2018 along with an LRT infection test that uses tracheal aspirates.
Curetis said the regulatory submission is based on data from a clinical study of more than 1,400 prospective and retrospective patient samples that showed the test had an overall weighted average sensitivity of 90.1 percent and 94.7 percent, and an overall average weighted specificity of 98.4 percent and 97.9 percent, across all pathogens in the prospective and retrospective cohorts, respectively. The test's performance was confirmed in an additional set of 240 negative samples that were spiked with rare pathogens and resistance markers.
"We will continue to drive evaluations and adoption of our Unyvero application cartridges, and we also look to further menu expansions and conducting clinical trials," Curetis CEO Oliver Schacht said in a statement. He added that the firm aims to advance a Unyvero test for invasive joint infections toward an FDA regulatory submission as additional funding becomes available.
In May, Curetis said it will receive €6.5 million ($7.3 million) in gross proceeds under two financing facilities. The company ended the first quarter of the year with €6.2 million in cash and cash equivalents.