Sam Brusco, Associate Editor04.08.22
OraSure subsidiary DNA Genotek has been awarded de novo authorization from the U.S. Food and Drug Administration (FDA) for its OMNIgene GUT Dx (OMD-200) microbiome collection device. The company is also currently rolling out the device.
OMNIgene GUT Dx non-invasively collects human fecal samples and stabilizes DNA from the bacterial community to assess the microbiome profile by an assay validated for use with the device.
“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 told the press. “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’s microbiome collection device portfolio is used in over 90 countries and to date has been spotlighted in over 200 scientific publications.
OMNIgene GUT Dx non-invasively collects human fecal samples and stabilizes DNA from the bacterial community to assess the microbiome profile by an assay validated for use with the device.
“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 told the press. “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’s microbiome collection device portfolio is used in over 90 countries and to date has been spotlighted in over 200 scientific publications.