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  • Inside DNA Genotek → Press Releases → 2022

    Press Releases

    2022

    Nov 03

    • ORAcollect®·RNA (OR-100)
    • OraSure Technologies Receives General Clearance for its ORAcollect®•Dx Device for Over-theCounter (OTC) Use from the U.S. Food and Drug Administration (FDA)

      BETHLEHEM, Pa., Nov. 03, 2022 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in point-of-care and homediagnostic testing and sample collection technologies, announced today that the Company received U.S. FDA clearance for its ORAcollect®•Dx salivacollection device for OTC (i.e. direct-to-consumer) use. The device had been previously cleared for prescription use by the FDA...

    Jul 14

    • ORAcollect®·RNA (OR-100)
    • OraSure Technologies Launches New Product for Microbiome Researchers to Study DNA and RNA

      BETHLEHEM, Pa., July 14, 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 that its OMNIgene ® •GUT DNA and RNA product ( OMR-205 ) is now available to gut microbiome...

    Apr 07

    • ORAcollect®·RNA (OR-100)
    • 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.

    Mar 31

    • ORAcollect®·RNA (OR-100)
    • OraSure Technologies’ Subsidiary Diversigen Launches Metatranscriptomic Sequencing and Analysis Services for Gut Microbiome Samples

      BETHLEHEM, Pa., March 31, 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 that its’ Diversigen subsidiary has launched a new service to provide metatranscriptomic sequencing and analysis of gut microbiome samples.

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    DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc. (NASDAQ: OSUR), focuses on providing high-quality biological sample collection products and end-to-end services for human genomics, microbiome and infectious disease 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.

    © 2025 DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc., all rights reserved.

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