Post by icemandios on Apr 7, 2022 12:55:41 GMT
OraSure Technologies’ Subsidiary DNA Genotek Launches the First Device with De Novo Authorization from the FDA for the Preservation and Stabilization of Microbiome Samples
BETHLEHEM, Pa., April 07, 2022 (GLOBE NEWSWIRE) -- 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.
About OraSure Technologies
OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. OraSure, together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com .
About DNA Genotek
DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc., focuses on providing high-quality biological sample collection products and end-to-end services for human genomics and microbiome applications. The Company's Oragene ® •Dx and ORAcollect ® •Dx product lines are the first and only FDA 510(k) cleared saliva-based DNA collection devices for in vitro diagnostic use. DNA Genotek also offers Research Use Only products to collect and preserve large amounts of DNA or RNA from multiple sample types. DNA Genotek markets its products worldwide and has a global customer base with thousands of customers in over 100 countries. For more information about DNA Genotek, visit www.dnagenotek.com
BETHLEHEM, Pa., April 07, 2022 (GLOBE NEWSWIRE) -- 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.
About OraSure Technologies
OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. OraSure, together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com .
About DNA Genotek
DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc., focuses on providing high-quality biological sample collection products and end-to-end services for human genomics and microbiome applications. The Company's Oragene ® •Dx and ORAcollect ® •Dx product lines are the first and only FDA 510(k) cleared saliva-based DNA collection devices for in vitro diagnostic use. DNA Genotek also offers Research Use Only products to collect and preserve large amounts of DNA or RNA from multiple sample types. DNA Genotek markets its products worldwide and has a global customer base with thousands of customers in over 100 countries. For more information about DNA Genotek, visit www.dnagenotek.com