April 7, 2022 – OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in point-of-care and home diagnostic testing and sample collection technologies, announced today its OMNIgene®·GUT Dx (OMD-200) microbiome collection device, has been granted de novo authorization from the U.S. Food and Drug Administration (FDA) and the Company is commercially launching the device.
OMNIgene®·GUT Dx allows for the non-invasive collection of human fecal samples and the stabilization of DNA from the bacterial community for subsequent assessment of the microbiome profile by an assay validated for use with OMNIgene®·GUT Dx.
“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. Given the innovation in the field, we believe we are on the cusp of seeing a number of FDA-authorized therapeutics and diagnostic products utilizing microbiome biomarkers,” said Kathleen Weber, President of Molecular Solutions for OraSure Technologies. “Microbiome therapeutics and diagnostics have the potential to aid health care providers in treating and preventing disease on a more personalized level, and OraSure is positioned as a leader in the microbiome field.”
DNA Genotek has a proven track record of supporting companies offering diagnostic testing in the human genomics space. Their microbiome collection device portfolio is used in more than 90 countries and has been featured in over 200 scientific publications to date.