NEW YORK — OraSure Technologies said on Thursday that its DNA Genotek subsidiary has received de novo authorization from the US Food and Drug Administration for a gut microbiome sample collection device.
The device, Omnigene-Gut Dx, is designed for the noninvasive self-collection and stabilization of microbial DNA from human feces for gut microbiome profiling. Bethlehem, Pennsylvania-based OraSure said that the collection device is now commercially available.
"This innovation will support our customers as they seek to launch clinical assays or therapeutics based on the microbiome and seek the reliability of an FDA-authorized device," Kathleen Weber, president of molecular solutions at OraSure, said in a statement.